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.
CopingPrimary· 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
Group
Value
95% CI
Coping Effectiveness Training (CET)
34.3
± 1.2
Cognitive-behavioral Therapy (CBT)
31.6
± 1.2
Acceptance and Commitment Therapy
33.2
± 1.2
Wait-list Control Group
30.0
± 1.2
Disengagement coping
Group
Value
95% CI
Coping Effectiveness Training (CET)
9.6
± .6
Cognitive-behavioral Therapy (CBT)
7.4
± .6
Acceptance and Commitment Therapy
8.7
± .6
Wait-list Control Group
7.6
± .6
Social support coping
Group
Value
95% CI
Coping Effectiveness Training (CET)
19.2
± .99
Cognitive-behavioral Therapy (CBT)
16.3
± .99
Acceptance and Commitment Therapy
16.4
± .99
Wait-list Control Group
14.9
± .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.
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Trials by the same sponsor.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 24 December 2018
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.