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

NCT ID: NCT01441258

Last Updated: 2015-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2015-02-28

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.

Conditions

Suicidal Ideation; Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study 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.

Group Type: EXPERIMENTAL

Dialectical Behavior Therapy Skills (DBT-S) Groups

Intervention Type: BEHAVIORAL

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).

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.

Group Type: PLACEBO_COMPARATOR

Wait List-Treatment as Usual

Intervention Type: BEHAVIORAL

Participants will be seen by their standard treaters for 18 weeks as usual.

No intervention-treatment as usual

Intervention Type: BEHAVIORAL

Participants will receive the intervention after 18 weeks in the treatment as usual group.

Interventions

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).

Intervention Type: BEHAVIORAL

Wait List-Treatment as Usual

Participants will be seen by their standard treaters for 18 weeks as usual.

Intervention Type: BEHAVIORAL

No intervention-treatment as usual

Participants will receive the intervention after 18 weeks in the treatment as usual group.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maurizio Fava, MD

OTHER

Sponsor Role: lead

Responsible Party

Maurizio Fava, MD

Executive Vice Chair, Department of Psychiatry

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Maurizio Fava, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Maren Nyer, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Harley R, Sprich S, Safren S, Jacobo M, Fava M. Adaptation of dialectical behavior therapy skills training group for treatment-resistant depression. J Nerv Ment Dis. 2008 Feb;196(2):136-43. doi: 10.1097/NMD.0b013e318162aa3f.

Reference Type: BACKGROUND

PMID: 18277222 (View on PubMed)

Nock MK, Park JM, Finn CT, Deliberto TL, Dour HJ, Banaji MR. Measuring the suicidal mind: implicit cognition predicts suicidal behavior. Psychol Sci. 2010 Apr;21(4):511-7. doi: 10.1177/0956797610364762. Epub 2010 Mar 9.

Reference Type: BACKGROUND

PMID: 20424092 (View on PubMed)

Other Identifiers

2011P001088

Identifier Type: -

Identifier Source: org_study_id