A Comparison of Two Psycho-educational Group Interventions for Tinnitus Patients

October 31, 2018 updated by: Tel-Aviv Sourasky Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-Aviv, Israel
        • Sourasky Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Tinnitus lasting more than 3 months
  • Hebrew speaking
  • Use hearing aids if needed
  • Signed informed consent

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CET
CET - Coping Effectiveness Training group.
Other: CET
Psycho-educational group
Experimental: ACT
ACT - Acceptance and Commitment Therapy group
Other: ACT
Psycho-educational group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COPE
Time Frame: Before the intervention (T1) and at the end of intervention (T2-4 weeks after T1), 1 month after end of intervention (T3)
Coping scale questionnaire
Before the intervention (T1) and at the end of intervention (T2-4 weeks after T1), 1 month after end of intervention (T3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2017

Primary Completion (Actual)

July 23, 2017

Study Completion (Actual)

July 23, 2017

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

February 24, 2017

First Posted (Actual)

March 3, 2017

Study Record Updates

Last Update Posted (Actual)

November 1, 2018

Last Update Submitted That Met QC Criteria

October 31, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0841-16-TLV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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