Back to resultsA Comparison of Two Psycho-educational Group Interventions for Tinnitus Patients
Primary Purpose
Tinnitus
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
ACT
CET
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus
Eligibility Criteria
Inclusion Criteria:
- Tinnitus lasting more than 3 months
- Hebrew speaking
- Use hearing aids if needed
- Signed informed consent
Exclusion Criteria:
- None
Sites / Locations
- Sourasky Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CET
ACT
Arm Description
CET - Coping Effectiveness Training group.
ACT - Acceptance and Commitment Therapy group
Outcomes
Primary Outcome Measures
COPE
Coping scale questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT03068871
First Posted
February 22, 2017
Last Updated
October 31, 2018
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03068871
Brief Title
A Comparison of Two Psycho-educational Group Interventions for Tinnitus Patients
Official Title
A Comparison of Two Psycho-educational Group Interventions for Tinnitus Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 28, 2017 (Actual)
Primary Completion Date
July 23, 2017 (Actual)
Study Completion Date
July 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
participants will be randomized into one of three groups: 3-session CET intervention, 3-session ACT intervention, or Waiting List group. Each weekly session will last up to 2 hours and 10 participants will be assigned to each group. There will be two cohorts, with 30 participants in each cohort. The Waiting List group will receive the CET intervention after the groups have completed theirs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CET
Arm Type
Experimental
Arm Description
CET - Coping Effectiveness Training group.
Arm Title
ACT
Arm Type
Experimental
Arm Description
ACT - Acceptance and Commitment Therapy group
Intervention Type
Other
Intervention Name(s)
ACT
Intervention Description
Psycho-educational group
Intervention Type
Other
Intervention Name(s)
CET
Intervention Description
Psycho-educational group
Primary Outcome Measure Information:
Title
COPE
Description
Coping scale questionnaire
Time Frame
Before the intervention (T1) and at the end of intervention (T2-4 weeks after T1), 1 month after end of intervention (T3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Tinnitus lasting more than 3 months
Hebrew speaking
Use hearing aids if needed
Signed informed consent
Exclusion Criteria:
None
Facility Information:
Facility Name
Sourasky Medical Centre
City
Tel-Aviv
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Comparison of Two Psycho-educational Group Interventions for Tinnitus Patients
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