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NCT02293512

A Comparison of Three Psychoeducational Group Interventions for Veterans With Tinnitus

Completed NA Results posted Last updated 24 December 2018
What this trial tests

NA trial testing Coping Effectiveness Training in Tinnitus in 40 participants. Completed in 30 November 2016.

Timeline
1 September 2015
Primary endpoint
31 August 2016
30 November 2016

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment40
Start date1 September 2015
Primary completion31 August 2016
Estimated completion30 November 2016
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Tinnitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Coping Primary · Baseline

The Brief COPE scale (Carver, 1997) is a widely-used 28-item short form of the COPE Inventory (Carver, Scheier et al., 1989). This instrument measures 14 coping subscales. Each item is scored using a 1-4 frequency scale (i.e., 1= "I haven't been doing this it at all" to 4= "I've been doing this a lot"), where higher scores reflect greater use of the coping strategy. A three-factor structure was used as follows: (a) Engagement coping (EC), including active coping, positive reframing, planning, accepting, and use of humor (items n = 12; score range 12-48); (b) disengagement coping (DC), includin

Engagement coping
GroupValue95% CI
Coping Effectiveness Training (CET)34.3± 1.2
Cognitive-behavioral Therapy (CBT)31.6± 1.2
Acceptance and Commitment Therapy33.2± 1.2
Wait-list Control Group30.0± 1.2
Disengagement coping
GroupValue95% CI
Coping Effectiveness Training (CET)9.6± .6
Cognitive-behavioral Therapy (CBT)7.4± .6
Acceptance and Commitment Therapy8.7± .6
Wait-list Control Group7.6± .6
Social support coping
GroupValue95% CI
Coping Effectiveness Training (CET)19.2± .99
Cognitive-behavioral Therapy (CBT)16.3± .99
Acceptance and Commitment Therapy16.4± .99
Wait-list Control Group14.9± .99

Sponsor's own description

Tinnitus (i.e., ringing in the ears) is currently the most prevalent disability among Veterans. A range of clinical interventions has been created to systematically address the range of issues caused by tinnitus. While numerous interventions purport to promote coping strategies for tinnitus-related problems, few studies directly target and measure coping outcomes. The present pilot study proposes a comparison of coping outcomes after 3 psycho-educational groups: a cognitive-behavioral therapy (CBT) intervention, a Coping Effectiveness Training (CET) intervention, or an Acceptance and Commitment Therapy intervention among Veterans with tinnitus. These groups will be compared to a usual care group among Veterans and civilians with tinnitus. The proposed study will be the first application of CET to tinnitus. The primary goals of this study are to develop a CET protocol for tinnitus and to evaluate the effectiveness of CBT, CET, and ACT interventions to a usual care group. The long-term goal of this study is to improve the quality of life among individuals with tinnitus.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Coping Effectiveness Training

Trials testing the same drug.

Other recruiting trials for Tinnitus

Currently open trials in the same condition.

Other VA Office of Research and Development trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02293512.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing