- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02499406
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
Conditions
Intervention / Treatment
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:
- Veterans at VACHS who are referred or self-referred to DBT Skills Group
- Ages 18-65
- Able to understand written and spoken English
- DERS score 105 or greater
- Suicidal ideation within past 3 months
- Seeing an individual mental health provider at VACHS at least monthly
- Willing to create or review a Mental Health Safety Plan, and stated willingness to use this plan to maintain safety
- Consent to participate in study assessments
- Consent to recording of group sessions
Exclusion Criteria:
- Inability to understand written or spoken English
- 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.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
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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