Trial Outcomes & Findings for Dialectical Behavior Therapy Skills Group Pilot Evaluation (NCT NCT02499406)

NCT ID: NCT02499406

Last Updated: 2021-01-20

Results Overview

Participation in skills group as assessed by attendance at sessions for duration of intervention (percent of sessions attended)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 17 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2021-01-20

Participant Flow

Participant milestones

Measure	Skills Group Dialectical behavior therapy skills group Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
Overall Study STARTED	17
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Skills Group Dialectical behavior therapy skills group Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
Overall Study missed 3 treatment sessions	4

Baseline Characteristics

Dialectical Behavior Therapy Skills Group Pilot Evaluation

Baseline characteristics by cohort

Measure	Skills Group n=17 Participants Dialectical behavior therapy skills group Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	42.7 years STANDARD_DEVIATION 11.94 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Percent of sessions attended

Participation in skills group as assessed by attendance at sessions for duration of intervention (percent of sessions attended)

Outcome measures

Measure	Skills Group n=17 Participants Dialectical behavior therapy skills group Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
Feasibility as Assessed by Attendance at Sessions for Duration of Intervention (Percent of Sessions Attended)	66.4 percentage of sessions attended Interval 11.5 to 100.0

SECONDARY outcome

Timeframe: 3 months

Population: 17 participants started the study; 15 provided scores on this measure at 3-month assessment.

Acceptability to participants on the "Client Satisfaction Scale" created for this study. Participants rated group satisfaction on 11 items using 7point scale. Scale is scored by calculating mean of the 11 items. Scale range is 1-7. A higher score indicates greater satisfaction; a lower score indicates greater dissatisfaction, with 4 as the midpoint.

Outcome measures

Measure	Skills Group n=15 Participants Dialectical behavior therapy skills group Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Mid-point of Intervention	5.44 score on a scale of satisfaction Standard Deviation 0.50

SECONDARY outcome

Timeframe: 6 months

Population: 17 participants started the study; 12 provided scores on this measure at 6-month assessment.

Acceptability to participants on the "Client Satisfaction Scale" created for this study. Participants rated group satisfaction on 11 items using 7point scale. Scale is scored by calculating mean of the 11 items. Scale range is 1-7. A higher score indicates greater satisfaction; a lower score indicates greater dissatisfaction, with 4 as the midpoint.

Outcome measures

Measure	Skills Group n=12 Participants Dialectical behavior therapy skills group Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Post-intervention	6.17 score on a scale of satisfaction Standard Deviation 0.50

SECONDARY outcome

Timeframe: 9 months

Population: 17 participants started the study; 12 provided scores on this measure at 9-month assessment.

Acceptability to participants on the "Client Satisfaction Scale" created for this study. Participants rated group satisfaction on 11 items using 7point scale. Scale is scored by calculating mean of the 11 items. Scale range is 1-7. A higher score indicates greater satisfaction; a lower score indicates greater dissatisfaction, with 4 as the midpoint.

Outcome measures

Measure	Skills Group n=12 Participants Dialectical behavior therapy skills group Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Follow-up	5.97 score on a scale Standard Deviation 0.39

SECONDARY outcome

Timeframe: 3 months

Population: 17 participants started the study; 15 provided scores on this measure at 3month assessment.

Scale title: Suicidal Behavior Questionnaire. Minimum value = 0, maximum value = 92. Higher score indicates greater suicidal ideation; lower score indicates lower suicidal ideation.

Outcome measures

Measure	Skills Group n=15 Participants Dialectical behavior therapy skills group Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
Suicidal Ideation on Suicidal Behavior Questionnaire at 3months	38.47 score on a scale Standard Deviation 15.43

SECONDARY outcome

Timeframe: 6 months

Population: 17 participants started the study. 12 contributed data on this measure at 6month assessment.

Scale title: Suicidal Behavior Questionnaire. Minimum value = 0, maximum value = 92. Higher score indicates greater suicidal ideation; lower score indicates lower suicidal ideation.

Outcome measures

Measure	Skills Group n=12 Participants Dialectical behavior therapy skills group Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
Suicidal Ideation on Suicidal Behavior Questionnaire at 6months	29.00 score on a scale Standard Deviation 22.19

SECONDARY outcome

Timeframe: 9 months

Population: 17 participants started the study. 12 contributed data on SBQ at 9month assessment.

Scale title: Suicidal Behavior Questionnaire. Minimum value = 0, maximum value = 92. Higher score indicates greater suicidal ideation; lower score indicates lower suicidal ideation.

Outcome measures

Measure	Skills Group n=12 Participants Dialectical behavior therapy skills group Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
Suicidal Ideation on Suicidal Behavior Questionnaire at 9months	28.25 score on a scale Standard Deviation 19.81

SECONDARY outcome

Timeframe: 3 months

Population: 17 participants started the study; 15 provided data on this measure at 3months.

Scale title: Difficulties in Emotion Regulation Scale (DERS). Scale range: 36-180. Higher score indicates greater difficulties regulating emotions. Lower score indicates fewer difficulties regulating emotions.

Outcome measures

Measure	Skills Group n=15 Participants Dialectical behavior therapy skills group Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 3months	107.27 score on a scale Standard Deviation 15.20

SECONDARY outcome

Timeframe: 6 months

Population: 17 participants started the study. 11 contributed data on DERS at 6months.

Scale title: Difficulties in Emotion Regulation Scale (DERS). Scale range: 36-180. Higher score indicates greater difficulties regulating emotions. Lower score indicates fewer difficulties regulating emotions.

Outcome measures

Measure	Skills Group n=11 Participants Dialectical behavior therapy skills group Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 6months (End of Intervention)	86.27 score on a scale Standard Deviation 12.81

SECONDARY outcome

Timeframe: 9 months

Population: 17 participants started the study. 12 contributed data on DERS at 9months.

Scale title: Difficulties in Emotion Regulation Scale (DERS). Scale range: 36-180. Higher score indicates greater difficulties regulating emotions. Lower score indicates fewer difficulties regulating emotions.

Outcome measures

Measure	Skills Group n=12 Participants Dialectical behavior therapy skills group Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 9months	84.92 score on a scale Standard Deviation 15.31

SECONDARY outcome

Timeframe: 3 months

Population: 17 participants started the study. 15 contributed data on this measure at 3 months.

Scale title: Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) effective coping subscale. Minimum score: 0. Maximum score: 3. Higher score indicates more frequent use of adaptive coping strategies. Lower score indicates less frequent use of adaptive coping strategies.

Outcome measures

Measure	Skills Group n=15 Participants Dialectical behavior therapy skills group Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
Coping as Assessed With the DBT (Dialectical Behavior Therapy) Ways of Coping Checklist at 3months	1.51 score on a scale Standard Deviation 0.40

SECONDARY outcome

Timeframe: 6 months

Population: 17 participants started the study. 11 participants contributed data on this measure at 6month assessment.

Scale title: Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) effective coping subscale. Minimum score: 0. Maximum score: 3. Higher score indicates more frequent use of adaptive coping strategies. Lower score indicates less frequent use of adaptive coping strategies.

Outcome measures

Measure	Skills Group n=11 Participants Dialectical behavior therapy skills group Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
Coping as Assessed With the DBT Ways of Coping Checklist at 6 Months	1.80 score on a scale Standard Deviation 0.41

SECONDARY outcome

Timeframe: 9 months

Population: 17 participants started the study; 12 contributed data on this measure at 9months

Scale title: Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) effective coping subscale. Minimum score: 0. Maximum score: 3. Higher score indicates more frequent use of adaptive coping strategies. Lower score indicates less frequent use of adaptive coping strategies.

Outcome measures

Measure	Skills Group n=12 Participants Dialectical behavior therapy skills group Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
Coping as Assessed With the DBT Ways of Coping Checklist at 9months	1.83 score on a scale Standard Deviation 0.50

Adverse Events

Skills Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Skills Group n=17 participants at risk Dialectical behavior therapy skills group Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
Psychiatric disorders inpatient hospitalization	5.9% 1/17 • Number of events 1 • 9 months

Other adverse events

Adverse event data not reported

Additional Information

Investigator

VACHS

Phone: 203 932 5711

Email: suzanne.decker@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place