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Dialectical Behavior Therapy Skills Group Pilot Evaluation

Primary Purpose

Suicidal Ideation, Emotions

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dialectical behavior therapy skills group
Sponsored by
VA Connecticut Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Connecticut Health Care System

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Skills group

Arm Description

Dialectical behavior therapy skills group

Outcomes

Primary Outcome Measures

Feasibility as Assessed by Attendance at Sessions for Duration of Intervention (Percent of Sessions Attended)
Participation in skills group as assessed by attendance at sessions for duration of intervention (percent of sessions attended)

Secondary Outcome Measures

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

Full Information

First Posted
June 1, 2015
Last Updated
December 28, 2020
Sponsor
VA Connecticut Healthcare System
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT02499406
Brief Title
Dialectical Behavior Therapy Skills Group Pilot Evaluation
Official Title
Dialectical Behavior Therapy Skills Group Pilot Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Connecticut Healthcare System
Collaborators
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Uncontrolled pilot study examines feasibility, acceptability, and preliminary efficacy of Dialectical Behavior Therapy skills group for Veterans with suicidal ideation and emotion dysregulation.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Emotions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Skills group
Arm Type
Other
Arm Description
Dialectical behavior therapy skills group
Intervention Type
Behavioral
Intervention Name(s)
Dialectical behavior therapy skills group
Intervention Description
Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
Primary Outcome Measure Information:
Title
Feasibility as Assessed by Attendance at Sessions for Duration of Intervention (Percent of Sessions Attended)
Description
Participation in skills group as assessed by attendance at sessions for duration of intervention (percent of sessions attended)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Mid-point of Intervention
Description
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.
Time Frame
3 months
Title
Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Post-intervention
Description
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.
Time Frame
6 months
Title
Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Follow-up
Description
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.
Time Frame
9 months
Title
Suicidal Ideation on Suicidal Behavior Questionnaire at 3months
Description
Scale title: Suicidal Behavior Questionnaire. Minimum value = 0, maximum value = 92. Higher score indicates greater suicidal ideation; lower score indicates lower suicidal ideation.
Time Frame
3 months
Title
Suicidal Ideation on Suicidal Behavior Questionnaire at 6months
Description
Scale title: Suicidal Behavior Questionnaire. Minimum value = 0, maximum value = 92. Higher score indicates greater suicidal ideation; lower score indicates lower suicidal ideation.
Time Frame
6 months
Title
Suicidal Ideation on Suicidal Behavior Questionnaire at 9months
Description
Scale title: Suicidal Behavior Questionnaire. Minimum value = 0, maximum value = 92. Higher score indicates greater suicidal ideation; lower score indicates lower suicidal ideation.
Time Frame
9 months
Title
Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 3months
Description
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.
Time Frame
3 months
Title
Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 6months (End of Intervention)
Description
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.
Time Frame
6 months
Title
Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 9months
Description
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.
Time Frame
9 months
Title
Coping as Assessed With the DBT (Dialectical Behavior Therapy) Ways of Coping Checklist at 3months
Description
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.
Time Frame
3 months
Title
Coping as Assessed With the DBT Ways of Coping Checklist at 6 Months
Description
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.
Time Frame
6 months
Title
Coping as Assessed With the DBT Ways of Coping Checklist at 9months
Description
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.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Decker, PhD
Organizational Affiliation
VA Connecticut Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Health Care System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Dialectical Behavior Therapy Skills Group Pilot Evaluation

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