Open access Protocol

BMJ Open: first published as 10.1136/bmjopen-2023-080863 on 17 October 2024. Downloaded from http://bmjopen.bmj.com/ on October 17, 2024 by guest. Protected by copyright.
SoundMind Trial: a study protocol for a
randomised controlled trial for online
acceptance and commitment therapy
and sound therapy for tinnitus
Xiaoling Huang,1 Dongmei Tang,2 Shan Sun ‍ ‍,3 Huawei Li1,3

To cite: Huang X, Tang D, ABSTRACT

Sun S, et al. SoundMind Introduction Tinnitus is a common ailment that affects STRENGTHS AND LIMITATIONS OF THIS STUDY
Trial: a study protocol for a 10%–15% of adults worldwide. Comorbidities associated ⇒ The study employs a combination of acceptance
randomised controlled trial and commitment therapy (ACT) and tailored sound
with tinnitus often include hearing loss, emotional
for online acceptance and therapy to tackle insomnia associated with tinnitus.
distress and sleep disorders, with insomnia being a
commitment therapy and sound
common issue among patients with tinnitus. Audiological ⇒ Comprehensive patient evaluation is ensured
therapy for tinnitus. BMJ Open
2024;14:e080863. doi:10.1136/ and psychological approaches are typically used to through the utilisation of standardised question-
bmjopen-2023-080863 treat chronic subjective tinnitus, with the combination naires, clinical interviews, audiometric evaluations
of sound therapy and cognitive–behavioural therapy-­ and targeted psychoacoustic measures for tinnitus.
► Prepublication history for ⇒ The online administration of ACT and sound therapy
based counselling having the strongest evidence for
this paper is available online. interventions will enable widespread accessibility,
effectiveness. Acceptance and commitment therapy (ACT)
To view these files, please visit
has also shown promising effects in reducing the impact of allowing patients to participate regardless of geo-
the journal online (https://doi.​
org/10.1136/bmjopen-2023-​ tinnitus when delivered in groups or online. However, there graphical location, thereby enhancing the study’s
080863). is a lack of evidence on the effects of combining ACT with reach and convenience.
sound therapy for patients with tinnitus-­related insomnia. ⇒ The study’s design does not include participant
XH and DT contributed equally. Therefore, this study aims to compare the efficacy of blinding to the interventions they receive, which
internet-­delivered ACT combined with sound therapy could introduce bias.
Received 12 October 2023 ⇒ The recruitment approach may not be representa-
versus sound therapy alone for tinnitus in a superiority,
Accepted 24 September 2024 tive of the entire tinnitus-­affected demographic, po-
two-­arm randomised controlled trial.
Methods and analysis A total of 164 patients with tentially limiting the generalisability of the findings.
chronic subjective tinnitus and insomnia will be
randomised to receive internet-­delivered guided self-­help
tinnitus treatment based on ACT combined with tailored
is often accompanied by anxiety, depression
sound therapy or tailored sound therapy alone. The primary
outcome is the variation in Tinnitus Handicap Inventory and sleep disturbance.3 Due to the hetero-
scores observed 2 months after randomisation between geneity in the aetiology and maintenance of
© Author(s) (or their tinnitus, a single treatment modality may not
the two study groups. Secondary outcomes will include
employer(s)) 2024. Re-­use
insomnia severity, sleep parameters, tinnitus loudness, be effective for all patients.4 Common clinical
permitted under CC BY-­NC. No
commercial re-­use. See rights tinnitus acceptance, depression and anxiety. The outcomes management strategies, such as education
and permissions. Published by will be assessed at 2, 3 and 6 months post randomisation. and counselling, sound therapy and cogni-
BMJ. Ethics and dissemination The study is approved by the tive–behavioural therapy (CBT), can be used
1
Department of Otolaryngology review board and ethics committee of the Eye and ENT to reduce the awareness of tinnitus and its
Head and Neck Surgery, Second Hospital of Fudan University (approval number: 2023066-­ impact on daily life.5
Affiliated Hospital of Anhui 1). The findings will be disseminated through presentations
Medical University, Hefei, Anhui,
Insomnia is common among patients with
at relevant conferences and peer-­reviewed publications.
China tinnitus and can further influence the percep-
Trial registration number NCT05963542.
2
ENT Institute and tion of tinnitus, thus reducing their quality
Otorhinolaryngology Department of life,6 and many of the available sedative-­
of Eye & ENT Hospital, Fudan INTRODUCTION hypnotic medications have disagreeable side-­
University Eye Ear Nose and
Throat Hospital, Shanghai, China
Tinnitus, which is described as the percep- effects. CBT is the first-­line evidence-­based
3
Department of ENT Institute tion of sound without any corresponding psychotherapy for tinnitus, and it aims to
and Otorhinolaryngology, Fudan external stimulus, is a common medical modify dysfunctional beliefs and behaviours
University Eye Ear Nose and problem.1 While the prevalence of tinnitus in order to reduce the annoyance and
Throat Hospital, Shanghai, China is around 10%–15%, it becomes bothersome distress associated with tinnitus.7 CBT for
Correspondence to and problematic for only a small proportion tinnitus includes various interventions such
Dr Shan Sun; of patients (3%–5%).2 Bothersome tinnitus as psychoeducation about tinnitus, relax-
​Shansun@​fudan.e​ du.​cn can interfere with all aspects of daily life and ation techniques, positive imagery, cognitive

Huang X, et al. BMJ Open 2024;14:e080863. doi:10.1136/bmjopen-2023-080863 1

Open access

BMJ Open: first published as 10.1136/bmjopen-2023-080863 on 17 October 2024. Downloaded from http://bmjopen.bmj.com/ on October 17, 2024 by guest. Protected by copyright.
restructuring, sound exposure and behavioural activa- by enriching the acoustic environment or by shifting
tion.8 In several studies, sleep management has become the attention away from the tinnitus.22 While both ACT
an additional module in traditional CBT for tinnitus and and tailored sound therapy are potentially effective treat-
has shown a slight improvement in sleep quality.9 ments, they have not been combined in tinnitus treat-
Acceptance and commitment therapy (ACT) is a part ment. In addition, face-­to-­face psychological treatment
of the ‘third wave’ of CBT and is rooted in functional has been limited by high costs, long-­waiting times and
contextualism and is guided by relational frame theory.10 therapist availability, and internet-­delivered ACT has the
Contextualism views the behavioural impact of thoughts potential to increase the accessibility of treatment.23
and feelings as dependent on context instead of content. Given the limited evidence on the efficacy of combining
In this framework, ACT provides another option to ACT with sound therapy for patients with tinnitus-­related
reduce the influence that thoughts and feelings exert insomnia, the proposed study aims to examine the effi-
over behaviour without necessarily reducing the inten- cacy of an internet-­delivered ACT combined with a sound
sity or frequency of such thoughts and feelings, whether therapy treatment programme among a sample of people
these include fear, hopelessness, anxiety, depression, with tinnitus and insomnia compared with sound therapy
pain or tinnitus. The general goal of ACT is to increase alone. We hypothesise that the combination of ACT and
psychological flexibility, the ability to fully engage with sound therapy will be superior to sound therapy alone in
the present moment as a conscious human being and the reducing tinnitus distress.
ability to continue with or change behaviour.
ACT has been found to be more effective than tinnitus
retraining therapy (TRT) and to be comparable to METHODS AND ANALYSIS
CBT in reducing tinnitus distress.11 12 In addition, ACT Study design and setting
is a transdiagnostic approach that provides broad and This will be a prospective, single-­centre, parallel-­group,
useful guidance across a wide range of problem areas.13 randomised controlled trial conducted at the Eye and
Evidence from randomised controlled trials suggests ENT Hospital of Fudan University in Shanghai. The
that ACT for tinnitus can also improve the sleep quality hospital is a large ear, nose and throat-­specialised hospital
of patients with tinnitus.11 While classical behaviour and has a sufficient number of outpatient visits to meet
therapy techniques for insomnia, such as sleep restriction the target sample size. Outpatients will be randomly
and stimulus control, were used in that study to address assigned to receive either internet-­ delivered guided
insomnia related to tinnitus, the ACT process of mind- self-­
help tinnitus treatment based on ACT combined
fulness, acceptance and defusion can indeed be used to with tailored sound therapy or to receive tailored sound
reduce cognitive arousals and counterproductive sleep therapy alone for 8 weeks, and all participants will be
efforts.14 At the same time, increased psychological flex- followed up for 3 months. The primary outcome is the
ibility also contributes to better sleep.15 16 Therefore, we variation in Tinnitus Handicap Inventory (THI) scores
expect that ACT-­based treatment for tinnitus will address observed 2 months after randomisation between the two
co-­occurring sleep difficulties and that patients with study groups. Secondary outcomes will include insomnia
tinnitus and insomnia will be more likely to benefit from severity, sleep parameters, tinnitus loudness, tinnitus
such treatments. acceptance, depression and anxiety. We hypothesise that
Unlike masking therapy and TRT, which are non-­ the combination of ACT and sound therapy will be supe-
tailored sound therapies, recently developed tailored rior to sound therapy alone in reducing tinnitus distress.
sound therapies individually tailor sound to match the This protocol will follow the Standard Protocol Items:
levels hearing loss and the tinnitus parameters and seek Recommendations for Interventional Trials statement24
to modify the maladaptive auditory cortex reorganisa- (online supplemental additional file 1).
tion in order to inhibit or eliminate the tinnitus.17 Tailor-­
made notched music training (TMNMT) for tinnitus Participants
is based on the principle that spectrally notched music Participants who meet the following inclusion criteria will
can reduce cortical activity corresponding to the notch be included: (1) adults aged 18–80 years old, (2) expe-
centre frequency through lateral inhibition, thereby riencing subjective tinnitus for at least 3 months; (3) a
inhibiting the overactivated neurons associated with the score of 38 or more on the THI, (4) a score of 15 or more
tinnitus frequency. TMNMT has demonstrated significant on the Insomnia Severity Index (ISI), (5) 55 dB hearing
efficacy in reducing tinnitus distress and is also effective level or less for the average pure tone threshold (0.5 kHz,
in reducing subjective tinnitus loudness and emotional 1 kHz, 2 kHz) for the worse ear and (6) the ability to
disturbance.18–20 read and write in Chinese and use a smartphone with an
Combined approaches (such as sound therapy plus internet connection to work with text-­based material.
counselling) are commonly used in the management of Participants who meet any of the following exclusion
tinnitus.21 In some studies, CBT and sound stimulation criteria will be excluded: (1) pulsatile tinnitus or objective
were combined, but the sound stimulation provided by tinnitus, (2) organic sleep disorders, (3) other diseases
sound-­creating devices was not customised to the indi- that need to be treated first (eg, infections, tumours,
vidual, and it could only promote tinnitus habituation otosclerosis, Meniere’s disease or the acute stage of

2 Huang X, et al. BMJ Open 2024;14:e080863. doi:10.1136/bmjopen-2023-080863

 Open access

BMJ Open: first published as 10.1136/bmjopen-2023-080863 on 17 October 2024. Downloaded from http://bmjopen.bmj.com/ on October 17, 2024 by guest. Protected by copyright.
sudden sensorineural hearing loss), (4) severe mental by research team members who are blind to the assign-
illness or (5) undergoing other research that may affect ment, and under no circumstances will unblinding be
tinnitus or sleep. permissible. See figure 1 for the study flow chart.

Procedure Intervention
All interested and potential participants will undergo an
All components of the intervention will be conducted
eligibility screening procedure at the outpatient clinic. The
online. The combined treatment group will receive ACT
screening will include standardised measures of tinnitus,
along with sound therapy, while the single treatment
insomnia and potential organic sleep disorders, such as
group will receive sound therapy alone. No other tinnitus
pure tone audiometry, acoustic immittance, tinnitus pitch
or insomnia treatment will be allowed during the trial
matching and loudness matching, minimum masking
period.
level, THI score, ISI score and the Hospital Anxiety and
Distress Scale (HADS) score. Eligible individuals will
be invited to meet with an investigator to collect base- Acceptance and commitment therapy
line data and provide informed consent (online supple- ACT for tinnitus will be guided as an internet-­delivered
mental additional file 2). The randomisation process will therapy and will include structured self-­ help material
be conducted by an independent statistician who will delivered through a smartphone. Therapists will be
use a computer-­generated random number sequence to available to provide support and guidance throughout
allocate participants to two groups in a 1:1 ratio without the treatment process, and the participants and thera-
stratification. To ensure allocation concealment, the pists will communicate via the instant messaging mobile
randomisation sequence will be obscured through the app WeChat. The self-­help material is mainly in Chinese
use of sequentially numbered opaque sealed envelopes. and includes text, images and audio components. It was
Recruitment of participants has started in September written by the research team based on the ACT model,10
2023 and is expected to end in October 2024. referencing published ACT treatment manuals25 and
This trial is single blinded and it is not possible to blind incorporating relevant research on ACT interventions for
the participants or therapists due to the nature of the tinnitus,11 12 and experiential exercises and metaphors
intervention. All outcome assessments will be conducted are frequently used in the intervention. The first version

Figure 1 Study flow chart.

Huang X, et al. BMJ Open 2024;14:e080863. doi:10.1136/bmjopen-2023-080863 3

Open access

BMJ Open: first published as 10.1136/bmjopen-2023-080863 on 17 October 2024. Downloaded from http://bmjopen.bmj.com/ on October 17, 2024 by guest. Protected by copyright.
of the material was reviewed by a licensed psychologist whether the participant has assimilated the material and is
with extensive experience in ACT. ready to move on to the next module. An outline of treat-
In general, ACT reduces the impact of tinnitus and ment content is presented in table 1.
tinnitus-­related distressing thoughts and feelings by
teaching psychological techniques (eg, mindfulness tech- Sound therapy
niques) to effectively deal with these while helping partici- The research team developed the Fudan Tinnitus
pants to clarify their values and to identify what is important Relieving System (FTRS) app, which provides tailored
and meaningful to them. The participants are then guided, sound therapy modulation based on self-­ described
motivated and facilitated in setting goals and taking life-­ tinnitus pitch and loudness matching.26 Participants will
enriching actions. The self-­help material covers the six core listen to tailor-­made music through the app for more than
processes of ACT, namely acceptance, cognitive defusion, 2 hours/day. The music will play using speakers and will
being present, the self-­as-­context, values and committed be kept slightly higher than the tinnitus volume for better
action, and it emphasises psychological flexibility. The desensitisation. The app provides tinnitus education,
material is 34 pages long and is divided into 8 modules that including popular science articles and lectures, through
include information, exercises and homework. The text a tinnitus forum.
and images in the modules are available in PDF format, and Outcome measures
the audio is available for download in MP3 format. Each Table 2 provides an overview of the outcome measures
module will be studied over 1 week, and the treatment will and the time points of assessment.
last a total of 8 weeks. Participants will be asked to complete
the exercises and homework assignments and to report the Primary outcome measures
results of specific homework assignments weekly through The primary outcome measure is the change in THI scores
WeChat. The therapist will use those reports to evaluate observed between the two groups at 2 months following

Table 1 Acceptance and commitment therapy for tinnitus

Modules Contents Assignment
1 Introduction to tinnitus Mindful breathing
Treatment rationale
Case conceptualisation
Introduction to mindfulness
Mindful breathing (exercise)
2 The white elephant (metaphor) Mindful breathing
Creative hopelessness
Pushing against the clipboard (metaphor)
Tug-­of-­war (metaphor)
3 The thinking self and the observing self Name the story (exercise)
The mind as a storyteller (metaphor) Leaves in a stream (meditation)
Writing thoughts down on a card (metaphor)
Defusion technique (exercise)
4 Demons on the boat (metaphor) Acceptance of emotions
Wade through the swamp (metaphor)
Acceptance of emotions (exercise)
5 The mind as a problem-­solving machine (metaphor) Mindful breathing
Mindfully eating a raisin (exercise) Mindful of morning routines and domestic chores
6 Three senses of self The continuous you
The slit lamp (metaphor)
The chessboard (metaphor)
The continuous you (exercise)
7 What values are Mindful breathing
The compass (metaphor)
Two kids in the car (metaphor)
Clarifying and contacting values (exercise)
8 Mountain climbing (metaphor) The willingness and action plan
Setting value-­based goals
Barriers to action
Breaking commitments
An outline of treatment content.

4 Huang X, et al. BMJ Open 2024;14:e080863. doi:10.1136/bmjopen-2023-080863

 Open access

BMJ Open: first published as 10.1136/bmjopen-2023-080863 on 17 October 2024. Downloaded from http://bmjopen.bmj.com/ on October 17, 2024 by guest. Protected by copyright.
Table 2 Schedule of enrolment, interventions and assessments
Study period
Enrolment Allocation Treatment Post treatment
Timepoint −t1 t0 1M 2M 3M 6M
Enrolment:
 Eligibility screening X
 Informed consent X
 Allocation X
Interventions:
 ACT+sound therapy group X X
 Sound therapy group X X
Assessments:
 Tinnitus Handicap Inventory (THI) X X X X
 Insomnia Severity Index (ISI) X X X X
 2 weeks sleep parameters X X X X
 Visual Analogue Scale (VAS) X X X X
 Hospital Anxiety and Depression Scale (HADS) X X X X
 Tinnitus Acceptance Questionnaire (TAQ) X X X X

randomisation.27 The THI questionnaire is widely used will be analysed and scored using specific algorithms to
in research and includes functional, emotional and generate sleep parameters.31
catastrophic subscales. It consists of 25 questions, and
answers are rated on a ‘yes’ (four points), ‘sometimes’ Visual Analogue Scale (VAS)
(two points) and ‘no’ (zero points) scale. The total score Subjective perception of tinnitus loudness will be assessed
is calculated by adding up the scores for all questions and using the VAS. Participants will be asked to rate the
classifying the severity of tinnitus as no handicap (0–16), loudness of their tinnitus on a scale ranging from 0 (no
mild handicap (18–36), moderate handicap (38–56) and tinnitus) to 10 (tinnitus could not be louder).
severe handicap (58–100).28 In this proposed study, the
validated Chinese version of the THI,29 which has high Hospital Anxiety and Distress Scale
test–retest reliability (r=0.98) and internal consisten- HADS is a 14-­item self-­report questionnaire with two 7-­item
cy(α=0.93), will be used. subscales that assess symptoms of anxiety (HADS-­A) and
depression (HADS-­D).32 Each item is scored on a scale of
Secondary outcome measures 0–3, with each subscale ranging from 0 to 21. A threshold
The secondary outcome measures will include the value of 8 or greater for the HADS-­A or HADS-­D indicates
following. clinically significant symptoms of anxiety or depression.33
The Chinese version of the HADS shows satisfactory
Insomnia Severity Index psychometric properties.34
The ISI is a self-­report questionnaire that assesses the
severity and impact of insomnia over the last 2 weeks. The Tinnitus Acceptance Questionnaire (TAQ)
questionnaire consists of seven items that evaluate the The TAQ consists of 12 items divided into two factors—
time until sleep onset, sleep maintenance, early morning activity engagement and tinnitus suppression—and it
awakening problems, sleep dissatisfaction, interference is widely used as a measure of experiential avoidance/
with daytime functioning by sleep difficulties, notice- acceptance in relation to tinnitus. The total score is 72,
ability of sleep problems by others and distress caused by with higher scores indicating a higher level of tinnitus-­
sleep difficulties. Each item is scored on a 0–4 scale, and related acceptance.35
the total score is interpreted as the absence of insomnia
(0–7), subthreshold insomnia (8–14), moderate insomnia Withdrawal
(15–21) and severe insomnia (22–28).30 Participants will be informed that they can withdraw from
the study at any time without any negative consequences
Sleep parameters on their subsequent treatment choices. Detailed records
Objective sleep will be estimated with actigraphy. Actig- will be maintained to document the reasons for with-
raphy (Atiwatch Spectrum Plus) consists of a small watch drawal. Additionally, any unplanned events experienced
worn on the participant’s non-­dominant wrist that stores by participants during the study follow-­up period, such
data about time and body movement. The collected data as significant hearing loss or vertigo, will be classified

Huang X, et al. BMJ Open 2024;14:e080863. doi:10.1136/bmjopen-2023-080863 5

Open access

BMJ Open: first published as 10.1136/bmjopen-2023-080863 on 17 October 2024. Downloaded from http://bmjopen.bmj.com/ on October 17, 2024 by guest. Protected by copyright.
as adverse events (AEs). All AEs will be recorded and on the pertinent baseline characteristic. The 95% CI for
reported to the chief investigator. the average difference in outcomes between the two treat-
ment groups will be scrutinised against the predefined
Trial management and quality control margin of seven points for the THI. Should the lower limit
Data collection will be conducted through the FTRS app, of the 95% CI fall below –7, the intervention combining
which is designed to administer validated surveys online. ACT with sound therapy can be regarded as having a
At the outset and for subsequent analyses, baseline and superior effect. IBM SPSS Statistics for Windows, V.24.0
outcome information will be documented in a digital case (IBM Corp.) will be used for all the statistical analyses.
report form. Additionally, research assistants will perform
follow-­up assessments by reaching out to patients to gather Patient and public involvement
the necessary data. A data monitoring committee, which Patients and the public were not engaged in the develop-
is independent of the trial investigators, has been estab- ment, execution, reporting or distribution of the findings
lished to monitor safety. This trial will be coordinated and of this study.
guided by the investigators of the study team. Changes
in the study protocol, the progression of the study and
serious AEs will be reported to the ethics committee. DISCUSSION
Personally identifiable information will be encrypted, and Sound therapy is one of the most widely researched treat-
all data will be kept confidential and stored on encrypted ments for tinnitus and includes masking therapy, hearing
servers and password-­protected devices. aids, TRT and a variety of tailored sound therapies. TRT
consists of directive counselling and sound therapy
Sample size designed to reclassify tinnitus perception to a neutral
To ensure an 80% statistical power with a type I error rate signal and to achieve habituation of the tinnitus.37 While
of 5%, we conducted a two-­sample t-­test for superiority. the efficacy of TRT and the contribution of counselling
The THI score difference after 8 weeks of intervention and sound therapy components remain controversial,
serves as the primary endpoint for this superiority trial. recent research suggests that using sound generators
An equivalence margin of 7 points was set, reflecting the in TRT can enhance treatment efficiency.38 Regarding
minimally clinically important difference for the THI, as tailored sound therapy, TMNMT can inhibit tinnitus
identified in prior research.36 Anticipating a mean differ- by reducing evoked activity in the auditory cortex areas
ence of 15.79 between the treatment groups, and based corresponding to the tinnitus frequency.18 Additionally,
on previous ACT studies on patients with tinnitus,11 we TMNMT has been shown to be more effective in reducing
established SD of 19.18 and 20.75 for the groups. This tinnitus distress than TRT.39
yielded a required sample size of 65 individuals per group. CBT is currently the first-­line evidence-­based psycho-
To compensate for a potential dropout rate of 20%, we therapy for tinnitus and can significantly reduce tinnitus
aim to enrol 82 participants for each group, totaling 164 distress while reducing the impact of tinnitus comorbidi-
participants. Power calculations suggest that with this ties such as anxiety, depression and insomnia.40 However,
sample size there is over 90% power to detect differences newer generations of CBT, such as ACT, may improve
in secondary outcomes, which include the ISI, HADS-­A, how we treat tinnitus-­ related problems. For example,
HADS-­D and TAQ. Participant enrolment will cease once studies have shown that interdisciplinary ACT can signifi-
the desired sample size has been achieved. cantly improve sleep in patients with chronic pain.
Furthermore, psychological flexibility has been shown to
Statistical analyses be strongly associated with improved sleep.16 Therefore,
Data will be presented as means and SD for continuous it is reasonable to expect that patients with tinnitus and
variables and as frequencies and percentages for categor- insomnia are more likely to benefit from ACT.
ical variables. Independent t-­tests and χ2 tests will be used Combining sound therapy and psychological interven-
to compare the differences between the baseline charac- tions has become a common approach in addressing both
teristics of the two groups. the physical and psychological aspects of patients with
To accommodate the longitudinal nature of the data, tinnitus. A recent pilot study provided personalised sound
a mixed-­effect model will be employed to evaluate the therapy and smartphone-­ based CBT to treat tinnitus,
temporal evolution of both primary and secondary and the results demonstrated that the group receiving
outcomes. Adhering to the intention-­to-­treat principle, the combined intervention experienced a significant
this analysis will include all participants as per their initial reduction in tinnitus distress compared with the waitlist
random assignment, irrespective of their adherence group.41 Still, the efficacy of the intervention needs to be
to the study protocol. In instances where missing data validated in a larger randomised controlled trial.
exceed 5%, sensitivity analyses using multiple imputa- This proposed study stands out from previous studies
tion will be undertaken to assess the potential influence by combining ACT and tailored sound therapy to address
of such missing data. In cases where baseline imbalances tinnitus-­related insomnia in patients. During the recruit-
that could affect the outcome exist between the treat- ment period of the study, patients will be assessed with
ment groups, stratified analyses will be conducted based standardised questionnaires, clinical interviews, complete

6 Huang X, et al. BMJ Open 2024;14:e080863. doi:10.1136/bmjopen-2023-080863

 Open access

BMJ Open: first published as 10.1136/bmjopen-2023-080863 on 17 October 2024. Downloaded from http://bmjopen.bmj.com/ on October 17, 2024 by guest. Protected by copyright.
hearing assessments and tinnitus-­specific psychoacoustic Open access This is an open access article distributed in accordance with the
assessments. These comprehensive evaluations will aim Creative Commons Attribution Non Commercial (CC BY-­NC 4.0) license, which
permits others to distribute, remix, adapt, build upon this work non-­commercially,
to fully characterise the patients with tinnitus, allowing and license their derivative works on different terms, provided the original work is
for an analysis of which types of patients are more likely properly cited, appropriate credit is given, any changes made indicated, and the use
to benefit from the treatment and to establish a basis is non-­commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
for individualised tinnitus treatment. In addition, ACT ORCID iD
and sound therapy will be delivered online, offering the Shan Sun http://orcid.org/0000-0003-2142-4307
advantage of easy accessibility regardless of the patient’s
location. However, this mode of delivery may result in
reduced contact with the therapist, potentially impacting REFERENCES
treatment compliance. 1 Baguley D, McFerran D, Hall D. Tinnitus. Lancet 2013;382:1600–7.
This proposed study also has some limitations. First, 2 Davis A, Refaie A. Epidemiology of Tinnitus, in The Handbook of
Tinnitus. San Diego: Singular Publishing Group, 2000:1–24.
participants will not be blinded to their intervention, 3 Langguth B. A review of tinnitus symptoms beyond 'ringing in the
which may introduce bias in their self-­reported outcomes. ears': a call to action. Curr Med Res Opin 2011;27:1635–43.
4 Piccirillo JF, Rodebaugh TL, Lenze EJ. Tinnitus. JAMA
Second, the study will exclude participants with profound 2020;323:1497–8.
hearing loss, which may limit the generalisability of the 5 Bauer CA. Tinnitus. N Engl J Med 2018;378:1224–31.
6 Miguel GS, Yaremchuk K, Roth T, et al. The effect of insomnia on
findings to the broader tinnitus population. Third, the tinnitus. Ann Otol Rhinol Laryngol 2014;123:696–700.
recruitment strategy might not capture the full spectrum 7 Fuller T, Cima R, Langguth B, et al. Cognitive behavioural therapy for
of the tinnitus population. Furthermore, the participants’ tinnitus. Cochrane Database Syst Rev 2020;1:CD012614.
8 Hesser H, Weise C, Westin VZ, et al. A systematic review and
psychological status, including anxiety and depression, meta-­analysis of randomized controlled trials of cognitive-­behavioral
may impact the degree of tinnitus perception and sleep therapy for tinnitus distress. Clin Psychol Rev 2011;31:545–53.
9 Curtis F, Laparidou D, Bridle C, et al. Effects of cognitive behavioural
quality, which may have confounding effects. therapy on insomnia in adults with tinnitus: Systematic review
In conclusion, this is the first study to evaluate the and meta-­analysis of randomised controlled trials. Sleep Med Rev
2021;56:101405.
efficacy of ACT combined with tailored sound therapy 10 Hayes SC, Luoma JB, Bond FW, et al. Acceptance and Commitment
in patients with tinnitus and insomnia. We predict that Therapy: Model, processes and outcomes. Behav Res Ther
psychotherapy and sound therapy may have some syner- 2006;44:1–25.
11 Westin VZ, et al. Acceptance and commitment therapy versus
gism and will be effective in improving patients’ tinnitus tinnitus retraining therapy in the treatment of tinnitus: a randomised
and sleep disturbances. Despite its limitations, this study controlled trial. Behav Res Ther 2011;49:737–47.
12 Hesser H, et al. A randomized controlled trial of Internet-­delivered
is expected to provide a foundation for exploring optimal cognitive behavior therapy and acceptance and commitment therapy
treatment options for tinnitus. in the treatment of tinnitus. J Consult Clin Psychol 2012;80:649–61.
13 Hayes SC. Acceptance and commitment therapy: towards a unified
model of behavior change. World Psychiatry 2019;18:226–7.
Acknowledgements We would like to acknowledge and thank all the staff in the 14 Saldaña KS, McGowan SK, Martin JL. Acceptance and Commitment
research center of the Eye, Ear, Nose, and Throat Hospital of Fudan University in Therapy as an Adjunct or Alternative Treatment to Cognitive
Shanghai. Behavioral Therapy for Insomnia. Sleep Med Clin 2023;18:73–83.
15 McCracken LM, Williams JL, Tang NKY. Psychological Flexibility
Contributors SS and HL conceived the review outlines, and XH and DT wrote the
May Reduce Insomnia in Persons with Chronic Pain: A Preliminary
manuscript. Retrospective Study. Pain Med 2011;12:904–12.
Funding This work was supported by the Key Research and Development Program 16 Daly-­Eichenhardt A, Scott W, Howard-­Jones M, et al. Changes
sponsored by the Ministry of Science and Technology (2023YFC2508402), the in Sleep Problems and Psychological Flexibility following
Interdisciplinary Acceptance and Commitment Therapy for Chronic
National Natural Science Foundation of China (nos. 82371146 and 82192862), the Pain: An Observational Cohort Study. Front Psychol 2016;7:1326.
Shanghai Science and Technology Committee (STCSM) Science and Technology 17 Wang H, Tang D, Wu Y, et al. The state of the art of sound therapy for
Innovation Program (no. 20MC1920200), Research Projects of Shanghai Municipal subjective tinnitus in adults. Ther Adv Chronic Dis 2020;11.
Health Committee (2022XD059) and the Shanghai Municipal Key Clinical Specialty 18 Okamoto H, Stracke H, Stoll W, et al. Listening to tailor-­made
(no. shslczdzk00801). The funding bodies will have no role in the study design, the notched music reduces tinnitus loudness and tinnitus-­related
collection, management, analysis, or interpretation of the data or the writing of the auditory cortex activity. Proc Natl Acad Sci U S A 2010;107:1207–10.
19 Teismann H, Okamoto H, Pantev C. Short and intense tailor-­made
manuscript.
notched music training against tinnitus: the tinnitus frequency
Competing interests None declared. matters. PLoS ONE 2011;6:e24685.
20 Tong Z, Deng W, Huang X, et al. Efficacy of Tailor-­Made Notched
Patient and public involvement Patients and/or the public were involved in the Music Training Versus Tinnitus Retraining Therapy in Adults With
design, or conduct, or reporting, or dissemination plans of this research. Refer to Chronic Subjective Tinnitus: A Randomized Controlled Clinical Trial.
the Methods section for further details. Ear Hear 2023;44:670–81.
21 Hobson J, Chisholm E, El Refaie A. Sound therapy (masking) in the
Patient consent for publication Not applicable. management of tinnitus in adults. Cochrane Database Syst Rev
Provenance and peer review Not commissioned; externally peer reviewed. 2010;2010:CD006371.
22 Hiller W, Haerkötter C. Does sound stimulation have additive effects
Supplemental material This content has been supplied by the author(s). It on cognitive-­behavioral treatment of chronic tinnitus? Behav Res
has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have Ther 2005;43:595–612.
been peer-­reviewed. Any opinions or recommendations discussed are solely 23 Herbert MS, Dochat C, Wooldridge JS, et al. Technology-­supported
those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability Acceptance and Commitment Therapy for chronic health
and responsibility arising from any reliance placed on the content. Where the conditions: A systematic review and meta-­analysis. Behav Res Ther
2022;148:103995.
content includes any translated material, BMJ does not warrant the accuracy and
24 Chan A-­W, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement:
reliability of the translations (including but not limited to local regulations, clinical defining standard protocol items for clinical trials. Ann Intern Med
guidelines, terminology, drug names and drug dosages), and is not responsible 2013;158:200–7.
for any error and/or omissions arising from translation and adaptation or 25 Harris R. ACT Made Simple: An Easy-­to-­Read Primer on Acceptance
otherwise. and Commitment Therapy. New Harbinger Publications, 2019.

Huang X, et al. BMJ Open 2024;14:e080863. doi:10.1136/bmjopen-2023-080863 7

Open access

BMJ Open: first published as 10.1136/bmjopen-2023-080863 on 17 October 2024. Downloaded from http://bmjopen.bmj.com/ on October 17, 2024 by guest. Protected by copyright.
26 Tang D, Wang K, Ye Z, et al. The Fudan Tinnitus Relieving System 35 Westin V, Hayes SC, Andersson G. Is it the sound or your relationship
(FTRS): The initial results of a smartphone application for tinnitus to it? The role of acceptance in predicting tinnitus impact. Behav Res
management and treatment. Internet Interv 2022;29:100564. Ther 2008;46:1259–65.
27 Newman CW, Jacobson GP, Spitzer JB. Development of the 36 Zeman F, Koller M, Figueiredo R, et al. Tinnitus handicap inventory
Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg for evaluating treatment effects: which changes are clinically
1996;122:143–8. relevant? Otolaryngol Head Neck Surg 2011;145:282–7.
28 Newman CW, Sandridge SA, Jacobson GP. Psychometric adequacy
37 Van der Wal A, Luyten T, Cardon E, et al. Sex Differences in
of the Tinnitus Handicap Inventory (THI) for evaluating treatment
outcome. J Am Acad Audiol 1998;9:153–60. the Response to Different Tinnitus Treatment. Front Neurosci
29 Meng Z, Zheng Y, Liu S, et al. Reliability and validity of the chinese 2020;14:422.
(mandarin) tinnitus handicap inventory. Clin Exp Otorhinolaryngol 38 Formby C, Yang X, Scherer RW. Contributions of Counseling and
2012;5:10–6. Sound Generator Use in Tinnitus Retraining Therapy: Treatment
30 Morin CM, Belleville G, Bélanger L, et al. The Insomnia Severity Response Dynamics Assessed in a Secondary Analysis of a
Index: psychometric indicators to detect insomnia cases and Randomized Trial. J Speech Lang Hear Res 2022;65:816–28.
evaluate treatment response. Sleep 2011;34:601–8. 39 Tong Z, Deng W, Huang X, et al. Efficacy of Tailor-­Made Notched
31 Ancoli-­Israel S, Martin JL, Blackwell T, et al. The SBSM Guide to Music Training Versus Tinnitus Retraining Therapy in Adults With
Actigraphy Monitoring: Clinical and Research Applications. Behav Chronic Subjective Tinnitus: A Randomized Controlled Clinical Trial.
Sleep Med 2015;13 Suppl 1:S4–38. E H 2023;44:670–81.
32 Zigmond AS, Snaith RP. The hospital anxiety and depression scale.
40 Beukes EW, Manchaiah V, Allen PM, et al. Internet-­Based
Acta Psychiatr Scand 1983;67:361–70.
Interventions for Adults With Hearing Loss, Tinnitus, and Vestibular
33 Bjelland I, Dahl AA, Haug TT, et al. The validity of the Hospital Anxiety
and Depression Scale. An updated literature review. J Psychosom Disorders: A Systematic Review and Meta-­Analysis. Trends Hear
Res 2002;52:69–77. 2019;23.
34 Chan Y-­F, Leung DYP, Fong DYT, et al. Psychometric evaluation of 41 Abouzari M, Goshtasbi K, Sarna B, et al. Adapting Personal
the Hospital Anxiety and Depression Scale in a large community Therapies Using a Mobile Application for Tinnitus Rehabilitation: A
sample of adolescents in Hong Kong. Qual Life Res 2010;19:865–73. Preliminary Study. Ann Otol Rhinol Laryngol 2021;130:571–7.

8 Huang X, et al. BMJ Open 2024;14:e080863. doi:10.1136/bmjopen-2023-080863