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Trial registered on ANZCTR


Registration number
ACTRN12624001048572
Ethics application status
Approved
Date submitted
30/07/2024
Date registered
29/08/2024
Date last updated
29/08/2024
Date data sharing statement initially provided
29/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of Audiologist-Delivered Psychological Intervention for Chronic Tinnitus (A-PICT) in Malaysia.
Scientific title
Efficacy of a Culturally Adapted Audiologist-Delivered Low-Intensity Psychological Intervention in Improving Severity and Distress among Chronic Tinnitus Patients in Malaysia.
Secondary ID [1] 312587 0
None
Universal Trial Number (UTN)
Trial acronym
A-PICT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic tinnitus 334514 0
Condition category
Condition code
Ear 331129 331129 0 0
Other ear disorders
Mental Health 331130 331130 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is generally a psychologically informed guidance manual to support audiologists in the management of tinnitus patients (Taylor et al., 2020). The 50-page manual comprises the introduction, patient assessment, rationale for psychological intervention, goal setting, patient education, eight modules of patient management/self-management, and relapse prevention. Together with the manual, a toolkit of 28 resources is available to facilitate the implementation of tinnitus management and support the patient's learning while navigating the process collaboratively with the audiologist.

Elements in patient education, delivered based on individual needs are causes and maintenance of tinnitus, misconceptions, information about the mechanism, its meaning, associations with hearing aids, hyperacusis, noise abuse, habituation to tinnitus, relaxation training, things to avoid, taming tinnitus takes time, and about masking.

The eight modules of patient management/self-management, which are also dependent on individual needs are managing the emotional consequences of tinnitus, rapid relaxation, managing fear and avoidance behaviours, changing unhelpful (negative) thoughts and beliefs, promoting physical exercise, promoting good sleeping habits, attention, monitoring and acceptance, as well as sound therapy (enrichment).

In the intervention group, the audiologist-delivered psychological intervention for chronic tinnitus (A-PICT) that has been culturally adapted will be delivered mainly in the form of talk therapy, one-to-one, and face-to-face to chronic tinnitus patients by the researcher, an audiologist with 10 years of clinical experience. He recently received specialized training in a dedicated workshop at University College Cork, Ireland, with the authors who developed the intervention manual. The intervention involves a total of 3 sessions (1 hour each), aimed to be completed within a month. In session 1, based on patient assessment, the individual participant will be provided with relevant educational counselling, reading materials and worksheets on cognitive-behavioural management strategies tailored to their needs. For example, if a participant manifests fear of tinnitus, the module on managing fear and avoidance behaviours will be provided. Apart from relevant education and reading materials about fear and tinnitus, an exposure worksheet from the toolkit of resources will be provided so the participant can self-practice and record at home for about a week. Self-efficacy and challenges encountered will be discussed and rectified in session 2, together with a non-optional module, rapid relaxation. Finally, in session 3, after the participants have successfully managed the relevant elements, the intervention will be concluded with relapse prevention.

To monitor participant adherence, the researcher will track the dates of the intervention sessions using a recorded form, updating the (re)scheduling of sessions as needed. The researcher will also contact participants via WhatsApp or phone call before their scheduled session as a reminder. However, participants may voluntarily withdraw from the study at any time.

Quantitative outcome measures, including the Tinnitus Functional Index (TFI) and the Depression, Anxiety, and Stress Scale-42 (DASS-42), will be administered at baseline, at the end of the intervention, and the 3-month follow-up. An intention-to-treat analysis will be adopted, including data from all participants who enrolled in the study, regardless of whether they completed the intervention. For participants with missing outcomes (dropped out/incomplete data), post-intervention scores will be imputed as pre-intervention scores, assuming the intervention does not worsen their tinnitus. Additionally, a semi-structured interview using the Theoretical Framework of Acceptability (TFA) questionnaire will be conducted with participants in the intervention group after the 3-month follow-up to gather insights into the acceptability of the intervention.

Reference: Taylor JA, Thompson DM, Hall DA, Walker DM, McMurran M, Casey A, et al. The TinMan study: feasibility trial of a psychologically informed, audiologist-delivered, manualised intervention for tinnitus. Int J Audiol [Internet]. 2020;0(0):905–14.
Intervention code [1] 329111 0
Treatment: Other
Comparator / control treatment
Participants in the control group will receive standard audiological care, including a hearing assessment and basic educational counseling about tinnitus (1 hour), delivered by an audiologist at the site who is not specially trained in managing tinnitus.

Quantitative outcome measures, including the Visual Analog Scale (VAS), Tinnitus Functional Index (TFI) and Depression, Anxiety, and Stress Scale-42 (DASS-42), will be administered at baseline, at the end of the intervention, and at the 3-month follow-up. An intention-to-treat analysis will be adopted, including data from all participants who enrolled in the study, regardless of whether they completed the intervention. For participants with missing outcomes (dropped out/incomplete data), post-intervention scores will be imputed as pre-intervention scores, assuming the intervention does not worsen their tinnitus. Ethically, if the adapted A-PICT intervention proves to be effective, participants in the control group will be offered the intervention following the analysis.
Control group
Active

Outcomes
Primary outcome [1] 338891 0
Tinnitus severity
Timepoint [1] 338891 0
Baseline, end of intervention, and 3-month follow-up
Secondary outcome [1] 437822 0
Tinnitus distress
Timepoint [1] 437822 0
Baseline, end of intervention, and 3-month follow-up

Eligibility
Key inclusion criteria
i. Adults, aged greater than or equal to 18 years, living in Malaysia
ii. Experiencing chronic subjective tinnitus for at least 6 months
iii. The ability to understand and write in simple Malay or English
iv. A tinnitus severity score of 25 and above on the Tinnitus Functional Index, indicating the need for intervention
v. Completed a routine audiological assessment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Tinnitus patients with current history of outer and middle ear disorders
ii. Reporting pulsatile, objective, or unilateral tinnitus, which has not been investigated medically or still under medical investigation
iii. Undergoing any tinnitus therapy concurrent with participation in this study
iv. Having a diagnosis of mental health and/or neurological disorders
v. Montreal Cognitive Assessment (MoCA) scores of 25 and below suggesting mild cognitive impairment
vi. Tinnitus patients with coexisting hyperacusis, based on the patient’s self-report and Khalfa Hyperacusis Questionnaire scores of 28 and above

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation: Using a computer software program called 'Research Randomizer,' the participants will then be randomized into the two groups (13 participants in each group).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation: An estimated sample size of 26 participants will first be stratified into two categories of tinnitus severity: small-to-moderate problems and big-to-very-big problems. This stratification ensures an equal proportion of participants with varying tinnitus severity in both the intervention and control groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Referring to a meta-analysis study by Ma Y et al. (2021) to see the efficacy of CBT for insomnia in breast cancer patients, total sample size for both treatment and comparison groups is estimated to be 26 subjects. It is calculated using G*Power calculator (version 3.1) based on following parameters:

F tests - ANOVA: Repeated measures, within-between interaction
Analysis: A priori: Compute required sample size
Input: Effect size f = 0.335
a err prob = 0.05
Power (1-ß err prob) = 0.95
Number of groups = 2
Number of measurements = 3
Corr among rep measures = 0.5
Nonsphericity correction = 1
Output: Noncentrality parameter = 17.5071000
Critical F = 3.1907273
Numerator df = 2.0000000
Denominator df = 48.0000000
Total sample size = 26
Actual power = 0.9612577

As for the statistical analyses:
1. Repeated measures ANOVA can be adopted to compare the tinnitus severity and distress at baseline, at the end of the intervention, and at the 3-month follow-up after the adapted A-PICT intervention.
2. Mixed design ANOVA will be used to assess the efficacy of the adapted A-PICT intervention by comparing tinnitus severity and distress at baseline, the end of intervention, and at the 3-month follow-up between treatment group and comparison group.
3. Thematic analysis is suitable to assess the acceptability of the adapted A-PICT intervention among chronic tinnitus patients in Malaysia.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/09/2024
Actual
Date of last participant enrolment
Anticipated
6/03/2025
Actual
Date of last data collection
Anticipated
6/04/2025
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment outside Australia
Country [1] 26453 0
Malaysia
State/province [1] 26453 0
Kuala Lumpur and Selangor

Funding & Sponsors
Funding source category [1] 317018 0
Hospital
Name [1] 317018 0
Sungai Buloh Hospital
Country [1] 317018 0
Malaysia
Funding source category [2] 317203 0
University
Name [2] 317203 0
the National University of Malaysia (UKM)
Country [2] 317203 0
Malaysia
Primary sponsor type
University
Name
the National University of Malaysia (UKM)
Address
Country
Malaysia
Secondary sponsor category [1] 319263 0
Government body
Name [1] 319263 0
Ministry of Health, Malaysia
Address [1] 319263 0
Country [1] 319263 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315774 0
Medical Research & Ethics Committee (MREC), Ministry of Health, Malaysia
Ethics committee address [1] 315774 0
Ethics committee country [1] 315774 0
Malaysia
Date submitted for ethics approval [1] 315774 0
Approval date [1] 315774 0
27/03/2024
Ethics approval number [1] 315774 0
23-03379-IUT
Ethics committee name [2] 315791 0
UKM Research Ethics Committee
Ethics committee address [2] 315791 0
Ethics committee country [2] 315791 0
Malaysia
Date submitted for ethics approval [2] 315791 0
Approval date [2] 315791 0
04/06/2024
Ethics approval number [2] 315791 0
JEP-2024-420

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135754 0
Dr Wan Syafira Ishak
Address 135754 0
Centre for Healthy Ageing and Wellness (H-CARE), Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur.
Country 135754 0
Malaysia
Phone 135754 0
+60 3 9289 5011
Fax 135754 0
Email 135754 0
wsyafira@ukm.edu.my
Contact person for public queries
Name 135755 0
Mohamad Azmeer Sadali
Address 135755 0
Centre for Healthy Ageing and Wellness (H-CARE), Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur.
Country 135755 0
Malaysia
Phone 135755 0
+60 13 755 5684
Fax 135755 0
Email 135755 0
P127323@siswa.ukm.edu.my
Contact person for scientific queries
Name 135756 0
Wan Syafira Ishak
Address 135756 0
Centre for Healthy Ageing and Wellness (H-CARE), Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur
Country 135756 0
Malaysia
Phone 135756 0
+60 3 9289 5011
Fax 135756 0
Email 135756 0
wsyafira@ukm.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Both ethics committees of Ministry of Health, Malaysia and the National University of Malaysia (UKM) delineated that all records and data are to be kept strictly confidential and can only be used for the purpose of this study.


What supporting documents are/will be available?




Results publications and other study-related documents

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