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Efficacy of Audiologist-Delivered Psychological Intervention for Chronic Tinnitus (A-PICT) in Malaysia.

Efficacy of a Culturally Adapted Audiologist-Delivered Low-Intensity Psychological Intervention in Improving Severity and Distress among Chronic Tinnitus Patients in Malaysia.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001048572
Acronym
A-PICT
Enrollment
26
Registered
2024-08-29
Start date
2024-09-06
Completion date
2025-03-06
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The main objective of the study is to evaluate the efficacy of audiologist-delivered low-intensity psychological intervention in reducing tinnitus severity and tinnitus distress among chronic tinnitus patients in Malaysia. The expected hypotheses are: 1. There is a significant reduction in tinnitus severity and tinnitus distress after receiving the A-PICT intervention. 2. The treatment group shows significant reduction in tinnitus severity and tinnitus distress as compared to the control group. 3. The adapted version of A-PICT intervention is acceptable among chronic tinnitus patients in Malaysia.

Interventions

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 a

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.

Sponsors

the National University of Malaysia (UKM)
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026