Adaptation of Dialectical Behavior Therapy Skills-Groups for Individuals With Suicidal Ideation and Depression
|ClinicalTrials.gov Identifier: NCT01441258|
Recruitment Status : Completed
First Posted : September 27, 2011
Last Update Posted : April 8, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Suicidal Ideation Major Depressive Disorder||Behavioral: Dialectical Behavior Therapy Skills (DBT-S) Groups Behavioral: Wait List-Treatment as Usual Behavioral: No intervention-treatment as usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adaptation of Dialectical Behavior Therapy Skills-Groups for Individuals With Suicidal Ideation and Depression|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Experimental: 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.
Behavioral: Dialectical Behavior Therapy Skills (DBT-S) Groups
The intervention will be delivered within an 18-week, once-weekly, one-and-half-hour skill group (8 participants per group) comprised of the same four modules administered in standard DBT skills training groups: (1) mindfulness, (2) interpersonal effectiveness, (3) emotion regulation, and (4) distress tolerance. There will be four sessions for each module totaling 16 sessions. There will be two booster sessions reviewing mindfulness and the concept of dialectics in-between each of the modules (i.e., between modules 2 and 3 and 3 and 4).
Placebo Comparator: 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.
Behavioral: Wait List-Treatment as Usual
Participants will be seen by their standard treaters for 18 weeks as usual.Behavioral: No intervention-treatment as usual
Participants will receive the intervention after 18 weeks in the treatment as usual group.
- Beck Scale for Suicidal Ideation (SSI) [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01441258
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Maurizio Fava, MD||Massachusetts General Hospital|
|Principal Investigator:||Maren Nyer, PhD||Massachusetts General Hospital|