Trial Outcomes & Findings for A Comparison of Three Psychoeducational Group Interventions for Veterans With Tinnitus (NCT NCT02293512)

Results Overview

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), including self-distancing, denial, behavioral disengagement, and self-blame (items n = 6; score range 6-24); and (c) social support coping (SS), including instrumenal support, emotional support, venting, and religion (items n = 8; score range 8-32).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Baseline

Results posted on

2018-12-24

Participant Flow

Participant milestones

Participant milestones
Measure	Coping Effectiveness Training (CET) A 3-session intervention to facilitate coping strategies among individuals with tinnitus. Coping Effectiveness Training for tinnitus: A CET psycho-educational intervention to increase understanding of stress and coping with tinnitus, and to better learn how to match appropriate coping strategies, based on whether the stressful situation is changeable or not.	Cognitive-behavioral Therapy (CBT) A 3-session intervention to reduce negative affectivity triggered by tinnitus. Cognitive-behavioral therapy (CBT): CBT treatments for tinnitus target the reduction of psychopathology by altering cognitive distortions, automatic thoughts, and core beliefs, as well as behavioral techniques to reduce physiological arousal.	Acceptance and Commitment Therapy A 3-session intervention to decrease resistance to tinnitus and increase committed action based on values, despite having tinnitus. Acceptance and Commitment Therapy for tinnitus: An ACT psycho-educational intervention to reduce distress and resistance about having tinnitus and to increase committed actions based on one's values.	Wait-list Control Group No intervention. This is a 'usual care' group.
Overall Study STARTED	10	10	10	10
Overall Study COMPLETED	6	4	7	8
Overall Study NOT COMPLETED	4	6	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of Three Psychoeducational Group Interventions for Veterans With Tinnitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Coping Effectiveness Training (CET) n=10 Participants A 3-session intervention to facilitate coping strategies among individuals with tinnitus. Coping Effectiveness Training for tinnitus: A CET psycho-educational intervention to increase understanding of stress and coping with tinnitus, and to better learn how to match appropriate coping strategies, based on whether the stressful situation is changeable or not.	Cognitive-behavioral Therapy (CBT) n=10 Participants A 3-session intervention to reduce negative affectivity triggered by tinnitus. Cognitive-behavioral therapy (CBT): CBT treatments for tinnitus target the reduction of psychopathology by altering cognitive distortions, automatic thoughts, and core beliefs, as well as behavioral techniques to reduce physiological arousal.	Acceptance and Commitment Therapy n=10 Participants A 3-session intervention to decrease resistance to tinnitus and increase committed action based on values, despite having tinnitus. Acceptance and Commitment Therapy for tinnitus: An ACT psycho-educational intervention to reduce distress and resistance about having tinnitus and to increase committed actions based on one's values.	Wait-list Control Group n=10 Participants No intervention. This is a 'usual care' group.	Total n=40 Participants Total of all reporting groups
Age, Continuous	52.1 years STANDARD_DEVIATION 18.9 • n=5 Participants	56.9 years STANDARD_DEVIATION 15.2 • n=7 Participants	61.6 years STANDARD_DEVIATION 17.6 • n=5 Participants	60.7 years STANDARD_DEVIATION 14.3 • n=4 Participants	57.8 years STANDARD_DEVIATION 16.4 • n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	8 Participants n=21 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	9 Participants n=4 Participants	32 Participants n=21 Participants
Region of Enrollment United States	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	40 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Brief COPE 3 factors (engagement, disengagement, and social support)

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), including self-distancing, denial, behavioral disengagement, and self-blame (items n = 6; score range 6-24); and (c) social support coping (SS), including instrumenal support, emotional support, venting, and religion (items n = 8; score range 8-32).

Outcome measures

Outcome measures
Measure	Coping Effectiveness Training (CET) n=10 Participants A 3-session intervention to facilitate coping strategies among individuals with tinnitus. Coping Effectiveness Training for tinnitus: A CET psycho-educational intervention to increase understanding of stress and coping with tinnitus, and to better learn how to match appropriate coping strategies, based on whether the stressful situation is changeable or not.	Cognitive-behavioral Therapy (CBT) n=10 Participants A 3-session intervention to reduce negative affectivity triggered by tinnitus. Cognitive-behavioral therapy (CBT): CBT treatments for tinnitus target the reduction of psychopathology by altering cognitive distortions, automatic thoughts, and core beliefs, as well as behavioral techniques to reduce physiological arousal.	Acceptance and Commitment Therapy n=10 Participants A 3-session intervention to decrease resistance to tinnitus and increase committed action based on values, despite having tinnitus. Acceptance and Commitment Therapy for tinnitus: An ACT psycho-educational intervention to reduce distress and resistance about having tinnitus and to increase committed actions based on one's values.	Wait-list Control Group n=10 Participants No intervention. This is a 'usual care' group.
Coping Engagement coping	34.3 units on a scale Standard Deviation 1.2	31.6 units on a scale Standard Deviation 1.2	33.2 units on a scale Standard Deviation 1.2	30.0 units on a scale Standard Deviation 1.2
Coping Disengagement coping	9.6 units on a scale Standard Deviation .6	7.4 units on a scale Standard Deviation .6	8.7 units on a scale Standard Deviation .6	7.6 units on a scale Standard Deviation .6
Coping Social support coping	19.2 units on a scale Standard Deviation .99	16.3 units on a scale Standard Deviation .99	16.4 units on a scale Standard Deviation .99	14.9 units on a scale Standard Deviation .99

Adverse Events

Coping Effectiveness Training (CET)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cognitive-behavioral Therapy (CBT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acceptance and Commitment Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wait-list Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Erin Martz, PhD

VA Portland Healthcare System

Phone: 503.220.8262

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place