Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia

Study Overview
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Brief Summary
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Considering the lack of evidence on the effects of combining acceptance and commitment therapy (ACT) with customized sound therapy for tinnitus-related insomnia patients, investigators designed this single-blind, 6-months randomized, controlled trial with two parallel groups. One is the ACT + sound therapy group, and the other is the sound therapy group.

Detailed Description
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Insomnia is one of the most frequent and severe comorbidities in patients with tinnitus and is highly relevant for the perceived tinnitus severity. Both tinnitus and insomnia significantly affect the quality of life of patients and represent a huge burden to society. While interventions exist to alleviate tinnitus distress, they often do not address sleep disturbances in tinnitus patients. Patients affected by tinnitus and insomnia suffer from long-term functional and psychological problems. Sound therapy is widely used to treat tinnitus, often combined with education and counseling, and can effectively improve the quality of life. In addition, acceptance and commitment therapy (ACT) for tinnitus improves both tinnitus and sleep. However, there is a lack of evidence on the effects of combining ACT with sound therapy for tinnitus-related insomnia patients. To fully characterize tinnitus patients, standardized measures of tinnitus and insomnia are essential. These measures include pure tone audiometry (PTA), acoustic immittance (AI), tinnitus pitch matching (PM) and loudness matching (LM), minimum masking level (MML), tinnitus handicap inventory (THI), insomnia severity index (ISI), and hospital anxiety and depression scale (HADS). Investigators hypothesize that the combination of ACT and sound therapy will be non-inferiority to sound therapy alone in reducing tinnitus distress.

Official Title
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SoundMind Trial: a Randomized Controlled Trial of Online Acceptance and Commitment Therapy and Sound Therapy for Tinnitus

Conditions
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Tinnitus, Insomnia

Intervention / Treatment
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* Behavioral: ACT for tinnitus
* Other: Customized sound therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged between 18 and 80 years old. Experiencing subjective tinnitus for at least 3 months. A score of 38 or more on THI. A score of 15 or more on ISI. 55 dB HL or less on the average pure tone threshold (0.5, 1, 2kHz) of the worse ear. Ability to read and write in Chinese and use a smartphone with an internet connection to work with text material. Exclusion Criteria: Pulsatile tinnitus and objective tinnitus. Organic sleep disorders. Other diseases that need to be treated first (e.g., infections, tumors, otosclerosis, Meniere's disease, the acute stage of sudden sensorineural hearing loss). Severe mental illness. Undergoing other research that may affect tinnitus and sleep.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT + sound therapy group<br>The combined treatment group will receive Internet-delivered guided self-help tinnitus treatment based on ACT combined with customized sound therapy. The online ACT program includes 8 modules of structured self-help material over 8 weeks. Each module includes information, exercises, and homework. The self-help material covers the six core processes of ACT: acceptance, cognitive defusion, being present, self-as-context, values, and committed action, emphasizing psychological flexibility. Customized sound therapy will be provided by the Fudan Tinnitus Relieving System (FTRS) app. Participants will listen to tailor-made music through the app for more than two hours per day. | Behavioral: ACT for tinnitus<br>* The intervention will be based on the ACT model and adjusted for tinnitus.<br>Other: Customized sound therapy<br>* The music will be modulated through a smartphone app using a set program to generate customized tinnitus relieving sound.<br>|
| Active Comparator: sound therapy group<br>The single treatment group will receive customized sound therapy provided by the FTRS app for more than two hours per day. | Other: Customized sound therapy<br>* The music will be modulated through a smartphone app using a set program to generate customized tinnitus relieving sound.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Handicap Inventory (THI) | The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a yes (4 points), sometimes (2 points), and no (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100). | 2 months from baseline | 
| Tinnitus Handicap Inventory (THI) | The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a yes (4 points), sometimes (2 points), and no (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100). | 3 months from baseline | 
| Tinnitus Handicap Inventory (THI) | The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a yes (4 points), sometimes (2 points), and no (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100). | 6 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index (ISI) | ISI is a self-report questionnaire that assesses the severity and impact of insomnia over the last two weeks. The questionnaire consists of seven items that evaluate the severity of sleep onset, sleep maintenance, early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by sleep difficulties. Each item is scored on a 0-4 scale, and the total score is interpreted as the absence of insomnia (0-7), sub-threshold insomnia (8-14), moderate insomnia (15-21), and severe insomnia (22-28). | 2 months from baseline | 
| Insomnia Severity Index (ISI) | ISI is a self-report questionnaire that assesses the severity and impact of insomnia over the last two weeks. The questionnaire consists of seven items that evaluate the severity of sleep onset, sleep maintenance, early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by sleep difficulties. Each item is scored on a 0-4 scale, and the total score is interpreted as the absence of insomnia (0-7), sub-threshold insomnia (8-14), moderate insomnia (15-21), and severe insomnia (22-28). | 3 months from baseline | 
| Insomnia Severity Index (ISI) | ISI is a self-report questionnaire that assesses the severity and impact of insomnia over the last two weeks. The questionnaire consists of seven items that evaluate the severity of sleep onset, sleep maintenance, early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by sleep difficulties. Each item is scored on a 0-4 scale, and the total score is interpreted as the absence of insomnia (0-7), sub-threshold insomnia (8-14), moderate insomnia (15-21), and severe insomnia (22-28). | 6 months from baseline | 
| Sleep Onset Latency (SOL) | SOL will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep. | 2 months from baseline | 
| Sleep Onset Latency (SOL) | SOL will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep. | 3 months from baseline | 
| Sleep Onset Latency (SOL) | SOL will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep. | 6 months from baseline | 
| Wake After Sleep Onset (WASO) | WASO will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep. | 2 months from baseline | 
| Wake After Sleep Onset (WASO) | WASO will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep. | 3 months from baseline | 
| Wake After Sleep Onset (WASO) | WASO will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep. | 6 months from baseline | 
| Sleep Efficiency (SE) | SE will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Higher score indicates better sleep. | 2 months from baseline | 
| Sleep Efficiency (SE) | SE will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Higher score indicates better sleep. | 3 months from baseline | 
| Sleep Efficiency (SE) | SE will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Higher score indicates better sleep. | 6 months from baseline | 
| Visual Analogue Scale (VAS) | Subjective perception of tinnitus loudness will be assessed using the VAS. Participants will be asked to rate the loudness of the tinnitus on a scale ranging from 0 (no tinnitus) to 10 (tinnitus could not be louder). | 2 months from baseline | 
| Visual Analogue Scale (VAS) | Subjective perception of tinnitus loudness will be assessed using the VAS. Participants will be asked to rate the loudness of the tinnitus on a scale ranging from 0 (no tinnitus) to 10 (tinnitus could not be louder). | 3 months from baseline | 
| Visual Analogue Scale (VAS) | Subjective perception of tinnitus loudness will be assessed using the VAS. Participants will be asked to rate the loudness of the tinnitus on a scale ranging from 0 (no tinnitus) to 10 (tinnitus could not be louder). | 6 months from baseline | 
| Hospital Anxiety and Distress Scale (HADS) | HADS is a 14-item self-report questionnaire with two 7-item subscales to assess symptoms of anxiety (HADS-A) and depression (HADS-D)[31]. Each item is scored from 0-3, with each subscale ranging from 0-21. A threshold value of 8 or greater for the HADS-A or HADS-D indicates clinically significant symptoms of anxiety or depression. | 2 months from baseline | 
| Hospital Anxiety and Distress Scale (HADS) | HADS is a 14-item self-report questionnaire with two 7-item subscales to assess symptoms of anxiety (HADS-A) and depression (HADS-D)[31]. Each item is scored from 0-3, with each subscale ranging from 0-21. A threshold value of 8 or greater for the HADS-A or HADS-D indicates clinically significant symptoms of anxiety or depression. | 3 months from baseline | 
| Hospital Anxiety and Distress Scale (HADS) | HADS is a 14-item self-report questionnaire with two 7-item subscales to assess symptoms of anxiety (HADS-A) and depression (HADS-D)[31]. Each item is scored from 0-3, with each subscale ranging from 0-21. A threshold value of 8 or greater for the HADS-A or HADS-D indicates clinically significant symptoms of anxiety or depression. | 6 months from baseline | 
| Tinnitus Acceptance Questionnaire (TAQ) | TAQ consists of 12 items divided into two factors: activity engagement and tinnitus suppression, and is widely used as a measure of experiential avoidance/acceptance in relation to tinnitus. The total score is 72, with higher scores indicating a higher level of tinnitus-related acceptance. | 2 months from baseline | 
| Tinnitus Acceptance Questionnaire (TAQ) | TAQ consists of 12 items divided into two factors: activity engagement and tinnitus suppression, and is widely used as a measure of experiential avoidance/acceptance in relation to tinnitus. The total score is 72, with higher scores indicating a higher level of tinnitus-related acceptance. | 3 months from baseline | 
| Tinnitus Acceptance Questionnaire (TAQ) | TAQ consists of 12 items divided into two factors: activity engagement and tinnitus suppression, and is widely used as a measure of experiential avoidance/acceptance in relation to tinnitus. The total score is 72, with higher scores indicating a higher level of tinnitus-related acceptance. | 6 months from baseline |