Dialectical Behavior Therapy Skills Group Pilot Evaluation

Suicidal Ideation Clinical Trial

Official title:

Dialectical Behavior Therapy Skills Group Pilot Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02499406
• Other study ID #: VACHS HSS 01883
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: March 2017

Study information

• Verified date: January 2020
• Source: VA Connecticut Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Emotions
• Suicidal Ideation

Intervention

Behavioral:
• Dialectical behavior therapy skills group
Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness

Locations

Country	Name	City	State
United States	VA Connecticut Health Care System	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
VA Connecticut Healthcare System	US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 months
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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.	9 months
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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.	9 months
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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.	9 months
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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.	9 months