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

This study is currently recruiting participants.
Verified November 2012 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01441258
First received: September 21, 2011
Last updated: November 12, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adaptation of Dialectical Behavior Therapy Skills-Groups for Individuals With Suicidal Ideation and Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression Suicide
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 37
Study Start Date: October 2011
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441258

Contacts
Contact: Kate A Hails, B.A. 617-643-7690 khails@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Kiki Fehling, BA     617-726-3129     kfehling@partners.org    
Principal Investigator: Maurizio Fava, MD            
Sub-Investigator: Maren Nyer, PhD            
Sponsors and Collaborators
Maurizio Fava, MD
Investigators
Principal Investigator: Maurizio Fava, MD Massachusetts General Hospital
Principal Investigator: Maren Nyer, PhD Massachusetts General Hospital
  More Information

Publications:

Responsible Party: Maurizio Fava, MD, Executive Vice Chair, Department of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01441258     History of Changes
Other Study ID Numbers: 2011P001088
Study First Received: September 21, 2011
Last Updated: November 12, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013