Dialectical Behavior Therapy Skills Group Pilot Evaluation

December 28, 2020 updated by: VA Connecticut Healthcare System
Uncontrolled pilot study examines feasibility, acceptability, and preliminary efficacy of Dialectical Behavior Therapy skills group for Veterans with suicidal ideation and emotion dysregulation.

Study Overview

Status

Completed

Detailed Description

Uncontrolled pilot study to examine feasibility, acceptability, and preliminary efficacy of Dialectical Behavior Therapy skills group for Veterans with suicidal ideation and emotion dysregulation. Outcome measures will occur at pre-treatment, mid, end, and follow-up.

Study Type

Interventional

Enrollment (Actual)

17

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

    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Health Care System

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Veterans at VACHS who are referred or self-referred to DBT Skills Group
  2. Ages 18-65
  3. Able to understand written and spoken English
  4. DERS score 105 or greater
  5. Suicidal ideation within past 3 months
  6. Seeing an individual mental health provider at VACHS at least monthly
  7. Willing to create or review a Mental Health Safety Plan, and stated willingness to use this plan to maintain safety
  8. Consent to participate in study assessments
  9. Consent to recording of group sessions

Exclusion Criteria:

  1. Inability to understand written or spoken English
  2. Diagnosis of schizophrenia, schizoaffective disorder, bipolar I, antisocial personality disorder, or thought disorder in CPRS problem list and confirmed by current mental health provider

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Skills group
Dialectical behavior therapy skills group
Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility as Assessed by Attendance at Sessions for Duration of Intervention (Percent of Sessions Attended)
Time Frame: 6 months
Participation in skills group as assessed by attendance at sessions for duration of intervention (percent of sessions attended)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Mid-point of Intervention
Time Frame: 3 months
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.
3 months
Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Post-intervention
Time Frame: 6 months
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.
6 months
Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Follow-up
Time Frame: 9 months
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.
9 months
Suicidal Ideation on Suicidal Behavior Questionnaire at 3months
Time Frame: 3 months
Scale title: Suicidal Behavior Questionnaire. Minimum value = 0, maximum value = 92. Higher score indicates greater suicidal ideation; lower score indicates lower suicidal ideation.
3 months
Suicidal Ideation on Suicidal Behavior Questionnaire at 6months
Time Frame: 6 months
Scale title: Suicidal Behavior Questionnaire. Minimum value = 0, maximum value = 92. Higher score indicates greater suicidal ideation; lower score indicates lower suicidal ideation.
6 months
Suicidal Ideation on Suicidal Behavior Questionnaire at 9months
Time Frame: 9 months
Scale title: Suicidal Behavior Questionnaire. Minimum value = 0, maximum value = 92. Higher score indicates greater suicidal ideation; lower score indicates lower suicidal ideation.
9 months
Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 3months
Time Frame: 3 months
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.
3 months
Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 6months (End of Intervention)
Time Frame: 6 months
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.
6 months
Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 9months
Time Frame: 9 months
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.
9 months
Coping as Assessed With the DBT (Dialectical Behavior Therapy) Ways of Coping Checklist at 3months
Time Frame: 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.
3 months
Coping as Assessed With the DBT Ways of Coping Checklist at 6 Months
Time Frame: 6 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.
6 months
Coping as Assessed With the DBT Ways of Coping Checklist at 9months
Time Frame: 9 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.
9 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Suzanne Decker, PhD, VA Connecticut Health Care System

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

December 1, 2014

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

June 1, 2015

First Submitted That Met QC Criteria

July 13, 2015

First Posted (Estimate)

July 16, 2015

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

December 28, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • VACHS HSS 01883

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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