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CBT-based Internet Intervention for Adults With Tinnitus in the United States

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04004260
Recruitment Status : Active, not recruiting
First Posted : July 2, 2019
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Vinaya Manchaiah, Lamar University

Tracking Information
First Submitted Date  ICMJE June 26, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date April 7, 2020
Actual Study Start Date  ICMJE March 1, 2020
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
Change in Tinnitus Functional Index (TFI) [ Time Frame: 8 weeks [Baseline; 2 month (last treatment session)] ]
The TFI is a 25-item questionnaire that evaluates treatment responsiveness (i.e., changes in functional effects of tinnitus over time). Total possible score ranges from 0-to-100 (scores >25 indicate tinnitus is a significant problem).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • Change in Tinnitus and Hearing Survey (THS) [ Time Frame: 8 weeks [Baseline; 2 month (last treatment session)] ]
    THS is a 10-item questionnaire that helps in determining how much of a patient's complaint about tinnitus is due to a hearing problem and how much is due specifically to the tinnitus. THS has three sections/subscales (A, B, and C). Section A consists of four items that address common tinnitus problems. Section B contains four items that address hearing. Section C, which includes two items, which focus on sound tolerance problem and ability to participate in group therapy. Responses for each item can range from 0 (not a problem) to 4 (very big problem). The total THS score can range from 0 to 40 (sections A and B range 0 to 16 and section C range from 0 to 8).
  • Change in Tinnitus Cognition Questionnaire (TCQ) [ Time Frame: 8 weeks [Baseline; 2 month (last treatment session)] ]
    TCQ is a 26-item questionnaire that assesses positive and negative cognitions associated with tinnitus. The first 13 items refer to negative thoughts and the second 13 items refer to positive thoughts. Responses are marked on a five-point Likert scale (0 to 4). The negative items (1-13) are scored 0-4, whereas the positive items (14-26) are reverse-scored: 4-0. The scoring procedure involves the simple addition of the number circled by the respondent for items 1-13 and the addition of reverse-scored items 14-26. The total score of the TCQ has a potential range from 0 to 104. A high score represents a greater tendency to engage in negative cognitions in response to tinnitus and low engagement in positive cognitions.
  • Change in Patient Health Questionnaire (PHQ-9) [ Time Frame: 8 weeks [Baseline; 2 month (last treatment session)] ]
    PHQ-9 is a 9-item questionnaire that assesses depression severity. Responses are marked on a four-point Likert scale (0 to 3). The total score can range from 0 to 27 with higher scores indicating more severe depression.
  • Change in Generalized Anxiety Disorder (GAD-7) [ Time Frame: 8 weeks [Baseline; 2 month (last treatment session)] ]
    GAD-7 is a 7-item questionnaire that assesses the severity of anxiety. Responses are marked on a four-point Likert scale (0 to 3). The total score can range from 0 to 21 with higher scores indicating more severe anxiety.
  • Change in Insomnia Severity Index (ISI) [ Time Frame: 8 weeks [Baseline; 2 month (last treatment session)] ]
    ISI is a 7-item questionnaire that evaluates insomnia. Responses are marked on a five-point Likert scale (0 to 4). The total score can range from 0 to 28 with higher scores indicating more severe insomnia.
  • Change in EuroQol EQ-5D-5L [ Time Frame: 8 weeks [Baseline; 2 month (last treatment session)] ]
    EQ-5D-5L is a 5-item questionnaire that evaluates health-related quality of life. Responses are marked on a five-point scale: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). The total score can range from 0 to 28 with higher scores indicating more severe insomnia. Possible health states is defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health). EQ-5D-5L health states are converted into a single index 'utility' score using a scoring algorithm based on public preferences.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CBT-based Internet Intervention for Adults With Tinnitus in the United States
Official Title  ICMJE Cognitive Behavior Therapy Based Self-help Delivered Via the Internet for Tinnitus Sufferers: Efficacy Trial in the U.S. Population
Brief Summary Nearly 50 million people in the U.S. experience tinnitus, of which about 20 million people have burdensome chronic tinnitus. Tinnitus can be very debilitating as many aspects of daily life can be affected, such as sleep, mood, and concentration. Currently, there is no cure for tinnitus. Pharmacological or sound-therapy based interventions are sometimes provided, but may be of limited value to certain individuals. Research suggests that Cognitive Behavior Therapy (CBT) based approaches have the most evidence of effectiveness in the management of tinnitus. However, CBT is rarely offered in the U.S. (less than 1%), partly attributed to a lack of trained professionals who can deliver CBT. To improve access to CBT for tinnitus, and online CBT program has been developed. The purpose of this study is to determine the feasibility and efficacy of a CBT Internet-based intervention for adults with tinnitus in the United States.
Detailed Description

Objective: This study aims to determine the feasibility and efficacy of an Internet-based Cognitive Behavior Therapy (ICBT) in reducing the impact associated with tinnitus in the United States.

Hypothesis: It is hypothesized that ICBT will result in reduced tinnitus-related distress, decreased sleep disturbance, decreased anxiety and depression, and improved health-related quality of life in a treatment group as compared with adults in the weekly check-in control-group in the U.S. population. The investigators also hypothesize that these results will be stable in both short- and long-term post-intervention.

Design: A two-armed Randomized Control Trial (RCT), with a one-year follow-up design will be used to evaluate the efficacy of ICBT on tinnitus distress.

Setting: This will be an Internet-based study for adults with tinnitus living in the State of Texas, USA.

Participants: Eligible participants will include adults with tinnitus for a minimum period of 3 months with internet access and no major medical or psychiatric conditions. 80 participants will be recruited for each group and will be randomly assigned using a computer-generated randomization schedule by an independent research assistant after being pre-stratified for language and tinnitus severity.

Intervention: The intervention offered is a guided CTB-based internet intervention (ICBT), providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.

Outcome measures: The main outcome measure is the Tinnitus Functional Index (TFI). Secondary outcome measures are the Tinnitus and Hearing Survey (THS), Tinnitus Cognition Questionnaire (TCQ), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder (GAD-7), Insomnia Severity Index (ISI), and EuroQol EQ-5D-5L.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The experimental group will initially undergo the ICBT intervention while the control group are monitored weekly. Once the experimental group has completed the intervention, the control group will undertake the ICBT intervention.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tinnitus
Intervention  ICMJE Behavioral: Internet-based Cognitive Behavior Therapy
The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Other Name: ICBT
Study Arms  ICMJE
  • Experimental: Experimental group
    The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned.
    Intervention: Behavioral: Internet-based Cognitive Behavior Therapy
  • Weekly check-in control group
    The weekly check-in control group will be monitored weekly by means of the Tinnitus Handicap Inventory-Screening version (THI-S) and the Tinnitus Qualities Questionnaire (TQQ). Once the experimental group completes the ICBT intervention, the control group undertake the same ICBT intervention.
    Intervention: Behavioral: Internet-based Cognitive Behavior Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 2, 2020)
158
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2019)
160
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. aged 18 years and older living in the State of Texas, USA;
  2. the ability to read and type in English or Spanish;
  3. no barriers to using a computer (e.g. no significant fine motor control or visual problems);
  4. Internet and e-mail access and the ability to use it;
  5. commitment to completing the program;
  6. completion of the online screening and outcome questionnaires;
  7. agreeing to participate in either group and be randomized to one of these groups;
  8. understanding and working towards the end goal of reducing the impact and distress of tinnitus, although the strength of the tinnitus may remain the same;
  9. be available for 12 months after starting the study to complete a 1-year follow-up questionnaire;
  10. suffering with experiencing tinnitus for a minimum period of 3 months; and
  11. tinnitus outcome measure scores indicating the need for tinnitus care [25 or above on the Tinnitus Functional Index (TFI)].

Exclusion Criteria:

  1. reporting any major medical or psychiatric conditions;
  2. reporting pulsatile, objective or unilateral tinnitus, which has not been investigated medically;
  3. tinnitus as a consequence of a medical disorder, still under investigation; and
  4. undergoing any other tinnitus therapy while participating in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04004260
Other Study ID Numbers  ICMJE R21DC017214( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The de-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Data will be available within 1-year of the study completion.
Access Criteria: Data access requests will be reviewed by the research team. Requestors will be required to sign a Data Access Agreement.
Responsible Party Vinaya Manchaiah, Lamar University
Study Sponsor  ICMJE Lamar University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vinaya Manchaiah, PhD Lamar University
PRS Account Lamar University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP