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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
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Uncontrolled pilot study examines feasibility, acceptability, and preliminary efficacy of Dialectical Behavior Therapy skills group for Veterans with suicidal ideation and emotion dysregulation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skills group | Other | Dialectical behavior therapy skills group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dialectical behavior therapy skills group | Behavioral | Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Decker, PhD | VA Connecticut Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Health Care System | West Haven | Connecticut | 06516 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Skills Group | Dialectical behavior therapy skills group Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Skills Group | Dialectical behavior therapy skills group Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Percent of sessions attended | Posted | Mean | Full Range | percentage of sessions attended | 6 months |
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9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Skills Group | Dialectical behavior therapy skills group Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| inpatient hospitalization | Psychiatric disorders | Non-systematic Assessment | psychiatric hospitalization in a participant who had previously dropped out of study |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Investigator | VACHS | 203 932 5711 | suzanne.decker@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 4, 2019 | Nov 11, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 9 months |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| 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. | 17 participants started the study; 15 provided scores on this measure at 3-month assessment. | Posted | Mean | Standard Deviation | score on a scale of satisfaction | 3 months |
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| 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. | 17 participants started the study; 12 provided scores on this measure at 6-month assessment. | Posted | Mean | Standard Deviation | score on a scale of satisfaction | 6 months |
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| 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. | 17 participants started the study; 12 provided scores on this measure at 9-month assessment. | Posted | Mean | Standard Deviation | score on a scale | 9 months |
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| 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. | 17 participants started the study; 15 provided scores on this measure at 3month assessment. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
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| 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. | 17 participants started the study. 12 contributed data on this measure at 6month assessment. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| 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. | 17 participants started the study. 12 contributed data on SBQ at 9month assessment. | Posted | Mean | Standard Deviation | score on a scale | 9 months |
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| 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. | 17 participants started the study; 15 provided data on this measure at 3months. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
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| 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. | 17 participants started the study. 11 contributed data on DERS at 6months. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| 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. | 17 participants started the study. 12 contributed data on DERS at 9months. | Posted | Mean | Standard Deviation | score on a scale | 9 months |
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| 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. | 17 participants started the study. 15 contributed data on this measure at 3 months. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
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| 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. | 17 participants started the study. 11 participants contributed data on this measure at 6month assessment. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| 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. | 17 participants started the study; 12 contributed data on this measure at 9months | Posted | Mean | Standard Deviation | score on a scale | 9 months |
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| 0 |
| 17 |
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| 17 |
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