Emotions, Suicidal Ideation
Conditions
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.
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.
Interventions
Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
Sponsors
US Department of Veterans Affairs
VA Connecticut Healthcare System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as Assessed by Attendance at Sessions for Duration of Intervention (Percent of Sessions Attended) | 6 months | Participation in skills group as assessed by attendance at sessions for duration of intervention (percent of sessions attended) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Post-intervention | 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. |
| Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Follow-up | 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. |
| Suicidal Ideation on Suicidal Behavior Questionnaire at 3months | 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. |
| Suicidal Ideation on Suicidal Behavior Questionnaire at 6months | 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. |
| Suicidal Ideation on Suicidal Behavior Questionnaire at 9months | 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. |
| Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Mid-point of Intervention | 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. |
| Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 6months (End of Intervention) | 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. |
| Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 9months | 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. |
| Coping as Assessed With the DBT (Dialectical Behavior Therapy) Ways of Coping Checklist at 3months | 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. |
| Coping as Assessed With the DBT Ways of Coping Checklist at 6 Months | 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. |
| Coping as Assessed With the DBT Ways of Coping Checklist at 9months | 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. |
| Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 3months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Skills Group Dialectical behavior therapy skills group
Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | missed 3 treatment sessions | 4 |
Baseline characteristics
| Characteristic | Skills Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 42.7 years STANDARD_DEVIATION 11.94 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 1 / 17 |
Outcome results
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)
Time frame: 6 months
Population: Percent of sessions attended
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Skills Group | Feasibility as Assessed by Attendance at Sessions for Duration of Intervention (Percent of Sessions Attended) | 66.4 percentage of sessions attended |
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.
Time frame: 9 months
Population: 17 participants started the study; 12 provided scores on this measure at 9-month assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skills Group | Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Follow-up | 5.97 score on a scale | Standard Deviation 0.39 |
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.
Time frame: 3 months
Population: 17 participants started the study; 15 provided scores on this measure at 3-month assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skills Group | Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Mid-point of Intervention | 5.44 score on a scale of satisfaction | Standard Deviation 0.5 |
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.
Time frame: 6 months
Population: 17 participants started the study; 12 provided scores on this measure at 6-month assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skills Group | Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Post-intervention | 6.17 score on a scale of satisfaction | Standard Deviation 0.5 |
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.
Time frame: 3 months
Population: 17 participants started the study. 15 contributed data on this measure at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skills Group | Coping as Assessed With the DBT (Dialectical Behavior Therapy) Ways of Coping Checklist at 3months | 1.51 score on a scale | Standard Deviation 0.4 |
Comparison: Null hypothesis is that there is no difference between baseline assessment and this 3-month assessment.p-value: >0.016paired sample t test
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.
Time frame: 6 months
Population: 17 participants started the study. 11 participants contributed data on this measure at 6month assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skills Group | Coping as Assessed With the DBT Ways of Coping Checklist at 6 Months | 1.80 score on a scale | Standard Deviation 0.41 |
Comparison: Null hypothesis is that there is no difference between baseline assessment and this 6-month assessment.p-value: =0.016paired sample t-test
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.
Time frame: 9 months
Population: 17 participants started the study; 12 contributed data on this measure at 9months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skills Group | Coping as Assessed With the DBT Ways of Coping Checklist at 9months | 1.83 score on a scale | Standard Deviation 0.5 |
Comparison: Null hypothesis is that there is no difference between baseline assessment and this 9-month assessment.p-value: <0.016paired sample t-test
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.
Time frame: 3 months
Population: 17 participants started the study; 15 provided data on this measure at 3months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skills Group | Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 3months | 107.27 score on a scale | Standard Deviation 15.2 |
Comparison: Null hypothesis is that there is no difference in paired samples between baseline and 3-month assessmentp-value: <0.016paired samples t test
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.
Time frame: 6 months
Population: 17 participants started the study. 11 contributed data on DERS at 6months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skills Group | Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 6months (End of Intervention) | 86.27 score on a scale | Standard Deviation 12.81 |
Comparison: Null hypothesis is no difference between baseline and this 6-month assessment.p-value: <0.016paired samples t test
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.
Time frame: 9 months
Population: 17 participants started the study. 12 contributed data on DERS at 9months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skills Group | Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 9months | 84.92 score on a scale | Standard Deviation 15.31 |
Comparison: Null hypothesis is no difference between baseline and this 9-month assessment.p-value: <0.016paired samples t test
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.
Time frame: 3 months
Population: 17 participants started the study; 15 provided scores on this measure at 3month assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skills Group | Suicidal Ideation on Suicidal Behavior Questionnaire at 3months | 38.47 score on a scale | Standard Deviation 15.43 |
Comparison: Null hypothesis is that there is no difference between baseline assessment and this 3-month assessment.p-value: >0.016paired sample t-test
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.
Time frame: 6 months
Population: 17 participants started the study. 12 contributed data on this measure at 6month assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skills Group | Suicidal Ideation on Suicidal Behavior Questionnaire at 6months | 29.00 score on a scale | Standard Deviation 22.19 |
Comparison: Null hypothesis is that there is no difference between baseline assessment and this 6-month assessment.p-value: <0.016paired sample t-test
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.
Time frame: 9 months
Population: 17 participants started the study. 12 contributed data on SBQ at 9month assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skills Group | Suicidal Ideation on Suicidal Behavior Questionnaire at 9months | 28.25 score on a scale | Standard Deviation 19.81 |
Comparison: Null hypothesis is that there is no difference between baseline assessment and this 9-month assessment.p-value: <0.016paired sample t-test