Suicidal IdeationNCT02499406
Dialectical Behavior Therapy Skills Group Pilot Evaluation
A study testing Dialectical behavior therapy skills group in people with Suicidal Ideation and Emotions, run by VA Connecticut Healthcare System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suicidal Ideation, Emotions
- What is being tested?
- Dialectical behavior therapy skills group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Health Care System
West Haven, Connecticut, 06516
About this study
Uncontrolled pilot study examines feasibility, acceptability, and preliminary efficacy of Dialectical Behavior Therapy skills group for Veterans with suicidal ideation and emotion dysregulation.
Read the 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.
- Conditions
- Suicidal Ideation, Emotions
- Being tested
- Dialectical behavior therapy skills group
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical behavior therapy skills groupBehavioural
Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
| Study group | Role | What they receive |
|---|---|---|
| Skills group | Other | Dialectical behavior therapy skills group Receives: Behavioral: Dialectical behavior therapy skills group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (12)
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 9 months
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 9 months
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 9 months
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startDec 2014
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Connecticut Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Suzanne Decker, PhD, Principal investigator, VA Connecticut Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499406
- Sponsor's protocol ID
- VACHS HSS 01883
- Status last verified
- Jan 2020
- First submitted
- 1 Jun 2015
- Last updated
- 20 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialectical Behavior Therapy Skills Group Pilot Evaluation
- ClinicalTrials.gov ID
- NCT02499406
- Acronym / sponsor ID
- VACHS HSS 01883
- Conditions
- Suicidal Ideation, Emotions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- Dec 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Posted 2 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skills group | Other | Behavioral: Dialectical behavior therapy skills groupDialectical behavior therapy skills group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialectical behavior therapy skills groupSkills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness | Behavioural | Skills group |
Primary outcome
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)
12 secondary outcomes
Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Mid-point of Intervention
Time frame: 3 months
Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Post-intervention
Time frame: 6 months
Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Follow-up
Time frame: 9 months
Suicidal Ideation on Suicidal Behavior Questionnaire at 3months
Time frame: 3 months
Suicidal Ideation on Suicidal Behavior Questionnaire at 6months
Time frame: 6 months
Suicidal Ideation on Suicidal Behavior Questionnaire at 9months
Time frame: 9 months
Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 3months
Time frame: 3 months
Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 6months (End of Intervention)
Time frame: 6 months
Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 9months
Time frame: 9 months
Coping as Assessed With the DBT (Dialectical Behavior Therapy) Ways of Coping Checklist at 3months
Time frame: 3 months
Coping as Assessed With the DBT Ways of Coping Checklist at 6 Months
Time frame: 6 months
Coping as Assessed With the DBT Ways of Coping Checklist at 9months
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Decker, PhD principal investigator
VA Connecticut Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical behavior therapy skills group in people with Suicidal Ideation and Emotions, run by VA Connecticut Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as Assessed by Attendance at Sessions for Duration of Intervention (Percent of Sessions Attended) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.