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Completed

NCT Number: NCT02499406

Dialectical Behavior Therapy Skills Group Pilot Evaluation

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

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Key information

Conditions

Suicidal Ideation Behavior Behavioral Symptoms Emotions Self-Injurious Behavior Suicide

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Connecticut Health Care System

West Haven, Connecticut, 06516, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dialectical behavior therapy skills group

Behavioral

Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

VA Connecticut Healthcare System

Fed

Collaborators

  • US Department of Veterans Affairs

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 16, 2015
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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