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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Insomnia; Tinnitus
• Intervention / Treatment: Behavioral: ACT for tinnitus; Other: Customized sound therapy

Detailed Description

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 superiority to sound therapy alone in reducing tinnitus distress.

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dongmei Tang; Phone Number: +86-13023299189; Email: tang.dongm@163.com
• Study Contact Backup: Name: Shan Sun; Phone Number: +86-021-64377134-2033; Email: sunshine7896@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Recruiting
      • Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department
      • Contact: Shan Sun, Phd; Phone Number: +86-021-64377134-2033; Email: sunshine7896@126.com
      • Contact: Dongmei Tang, Phd; Phone Number: +86-13023299189; Email: tang.dongm@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults aged between 18 and 80 years old.
2. Experiencing subjective tinnitus for at least 3 months.
3. A score of 38 or more on THI.
4. A score of 15 or more on ISI.
5. 55 dB HL or less on the average pure tone threshold (0.5, 1, 2kHz) of the worse ear.
6. Ability to read and write in Chinese and use a smartphone with an internet connection to work with text material.

Exclusion Criteria:

1. Pulsatile tinnitus and objective tinnitus.
2. Organic sleep disorders.
3. Other diseases that need to be treated first (e.g., infections, tumors, otosclerosis, Meniere's disease, the acute stage of sudden sensorineural hearing loss).
4. Severe mental illness.
5. Undergoing other research that may affect tinnitus and sleep.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACT + sound therapy group; 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; The intervention will be based on the ACT model and adjusted for tinnitus.; Other: Customized sound therapy; The music will be modulated through a smartphone app using a set program to generate customized tinnitus relieving sound.
Active Comparator: sound therapy group; 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; The music will be modulated through a smartphone app using a set program to generate customized tinnitus relieving sound.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University
• Investigators: Principal Investigator: Huawei Li, Eye and ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 16, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Sleep Initiation and Maintenance Disorders; Tinnitus
• Other Study ID Numbers: 2023066-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No