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NCT00724152 · ClinicalTrials.gov registry record · Phase 1
Cognitive Behavioral Therapy (CBT) for Tinnitus
A Phase 1 study, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT00724152: Completed Phase 1 study, sponsored by US Department of Veterans Affairs.
NCT00724152 is a Phase 1 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00724152, a Phase 1 study, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
This study examined how useful it is to teach veterans coping skills for dealing with tinnitus, also called ringing in the ears. A psychological intervention, cognitive-behavioral therapy, was used to teach coping skills even though tinnitus is not a psychological disorder. Participants in Period 1 of the study were assigned to one of two groups for the duration of the study and were blinded to their group assignment until the end of the study. One group received education about tinnitus. The other group received education about tinnitus plus additional ways to cope with problems associated with tinnitus such as sleep disturbance and frustration. Participants were selected to participate if their tinnitus was severe and they had been exposed to loud sound. Participants attended up to six weekly group meetings. It was predicted that participants who were randomly assigned to the cognitive behavioral therapy group would report a greater reduction in tinnitus severity than education controls. During Period 2 of the study, a third "standard care" arm was added. Baseline and outcome data of the 4 participants who completed the study after this third arm was added to the study design are not reported.
Primary Outcome
Most widely used measure of tinnitus distress available during study period. The THI was created using the Tinnitus Handicap Questionnaire and the Tinnitus Questionnaire as well as the Beck Depression Inventory and Modified Somatic Perception Questionnaire. Its construct validity was also assessed using patients' responses on symptom rating scales and auditory tests of pitch and loudness. The THI score ranges from 0 to 100, with 100 indicating the most severe tinnitus and 0 is the least severe t
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy
- BEHAVIORAL Tinnitus Education
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2009-02 |
| Est. Completion | 2011-02 |
| Phase | Phase 1 |
What the finished NCT00724152 record still lists
NCT00724152 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 2 interventions - of which Cognitive Behavioral Therapy is the first listed.
NCT00724152 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00724152 about?
NCT00724152 is a clinical study titled "Cognitive Behavioral Therapy (CBT) for Tinnitus". This study examined how useful it is to teach veterans coping skills for dealing with tinnitus, also called ringing in the ears. A psychological intervention, cognitive-behavioral therapy, was used to teach coping skills even though tinnitus is not a psychological disorder. Participants in Period 1 ...
What is the current status of trial NCT00724152?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2009-02. Estimated completion is 2011-02.
What interventions are being tested in trial NCT00724152?
The interventions under investigation include: Cognitive Behavioral Therapy (BEHAVIORAL), Tinnitus Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT00724152?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00724152's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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