NCT02499406

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

January 2, 2020

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2020

Enrollment Period

2.2 years

First QC Date

June 1, 2015

Results QC Date

November 20, 2019

Last Update Submit

December 28, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Mid-point of Intervention

    3 months

  • Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Post-intervention

    6 months

  • Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Follow-up

    9 months

  • Suicidal Ideation on Suicidal Behavior Questionnaire at 3months

    3 months

  • Suicidal Ideation on Suicidal Behavior Questionnaire at 6months

    6 months

  • +7 more secondary outcomes

Study Arms (1)

Skills group

OTHER

Dialectical behavior therapy skills group

Behavioral: Dialectical behavior therapy skills group

Interventions

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

Skills group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Health Care System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Limitations and Caveats

Some missing data in assessments due to attrition; planned absence of control arm for this small open feasibility pilot trial; absence of adherence coding due to logistical constraints

Results Point of Contact

Title
Investigator
Organization
VACHS

Study Officials

  • Suzanne Decker, PhD

    VA Connecticut Health Care System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2015

First Posted

July 16, 2015

Study Start

December 1, 2014

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

January 20, 2021

Results First Posted

January 2, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations