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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01441258
Recruitment Status : Completed
First Posted : September 27, 2011
Last Update Posted : April 8, 2015
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital

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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01441258

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Maurizio Fava, MD
Principal Investigator: Maurizio Fava, MD Massachusetts General Hospital
Principal Investigator: Maren Nyer, PhD Massachusetts General Hospital

Responsible Party: Maurizio Fava, MD, Executive Vice Chair, Department of Psychiatry, Massachusetts General Hospital Identifier: NCT01441258     History of Changes
Other Study ID Numbers: 2011P001088
First Posted: September 27, 2011    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Suicidal Ideation
Behavioral Symptoms
Mood Disorders
Mental Disorders
Self-Injurious Behavior