Adaptation of Dialectical Behavior Therapy Skills-Groups for Individuals With Suicidal Ideation and Depression

Not Applicable

Completed

• Conditions: Major Depressive Disorder; Suicidal Ideation
• Interventions: Behavioral: Wait List-Treatment as Usual; Behavioral: Dialectical Behavior Therapy Skills (DBT-S) Groups; Behavioral: No intervention-treatment as usual

• Registration Number: NCT01441258
• Lead Sponsor: Maurizio Fava, MD

Brief Summary

Harley and colleagues demonstrated that adding Dialectical Behavior Therapy (DBT) skills-groups and therapist consultation to treatment as usual successfully reduced symptoms of depression. The present study will expand upon these findings. Second, DBT is not known for reducing suicidal ideation (SI), a major risk factor for suicide . The present study will tailor the aforementioned skills-groups to specifically target suicidal thoughts and behaviors through Cognitive Behavior Therapy (CBT) strategies aimed at increasing problem-solving deficits, hopelessness, and negativistic thinking. Third, the present study will extend this DBT-based approach to a novel population. Fourth, the present study is the first DBT intervention to employ state-of-the-art multi-method measurement (including objective assessment) of suicidal thoughts and behaviors.

The investigators hypothesize that participants in the DBT skills (DBT-S) group will show improvements in level of suicidality as measured by decreased scores on the Beck Scale for Suicide Ideation as compared with participants in the Wait List-Treatment as Usual (WL-TAU) group.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-21
• Study First Submitted QC: 2011-09-26
• Study First Posted: 2011-09-27
• Study Start: 2011-10
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Participants will be at least 18 years of age.
2. Participants will meet criteria for Major Depressive Disorder (MDD) on the Structured Clinical Interviews for Axis I DSM-IV Disorders
3. Participants must report current suicidal ideation on the Self-Injurious Thoughts and Behaviors Interview
4. Participants must have an outpatient psychiatric provider who they see "regularly" (i.e., at least every other week for therapy, case management, or medication management).
5. English language proficiency.

Exclusion Criteria

1. DSM-IV diagnosis of bipolar disorder, schizophrenia, psychotic disorder NOS, or personality disorders.
2. Active current substance dependence.
3. Severe or unstable medical conditions that would prohibit regular group attendance or participation.
4. Other group therapy.
5. Significant dementia or cognitive impairment that would interfere with the learning of DBT skills.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wait List-Treatment as Usual	Wait List-Treatment as Usual	Participants assigned to the wait-list condition will be given the opportunity to participate in a DBT skills group after their 18-week wait period has ended.
Wait List-Treatment as Usual	No intervention-treatment as usual	Participants assigned to the wait-list condition will be given the opportunity to participate in a DBT skills group after their 18-week wait period has ended.
Dialectical Behavior Therapy Skills (DBT-S) Groups	Dialectical Behavior Therapy Skills (DBT-S) Groups	Patients in the Dialectical Behavior Therapy Skills (DBT-S) group will receive the newly adapted 18-week group-skills training protocol, one-and-a-half hours in length, with weekly homework assignments to facilitate skill generalization.

Primary Outcome Measures

Name	Time	Method
Beck Scale for Suicidal Ideation (SSI)	Participants will be assessed using the SSI monthly throughout the duration of their study participation for up to 15 months (see description for details)	If randomized to the intervention, they will be assessed monthly for 18 weeks, then at 3 and 6-month follow-up visits. If they are randomized to the Wait list-Treatment as Usual (WL-TAU) group and then cross over into the intervention group, they will be assessed for a total of 36 weeks, not including the 3 and 6-month follow-up assessments.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States