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

Primary Purpose

Suicidal Ideation, Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dialectical Behavior Therapy Skills (DBT-S) Groups
Wait List-Treatment as Usual
No intervention-treatment as usual
Sponsored by
Maurizio Fava, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dialectical Behavior Therapy Skills (DBT-S) Groups

Wait List-Treatment as Usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Beck Scale for Suicidal Ideation (SSI)
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.

Secondary Outcome Measures

Full Information

First Posted
September 21, 2011
Last Updated
April 7, 2015
Sponsor
Maurizio Fava, MD
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1. Study Identification

Unique Protocol Identification Number
NCT01441258
Brief Title
Adaptation of Dialectical Behavior Therapy Skills-Groups for Individuals With Suicidal Ideation and Depression
Official Title
Adaptation of Dialectical Behavior Therapy Skills-Groups for Individuals With Suicidal Ideation and Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maurizio Fava, MD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dialectical Behavior Therapy Skills (DBT-S) Groups
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait List-Treatment as Usual
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behavior Therapy Skills (DBT-S) Groups
Intervention Description
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
Intervention Name(s)
Wait List-Treatment as Usual
Intervention Description
Participants will be seen by their standard treaters for 18 weeks as usual.
Intervention Type
Behavioral
Intervention Name(s)
No intervention-treatment as usual
Intervention Description
Participants will receive the intervention after 18 weeks in the treatment as usual group.
Primary Outcome Measure Information:
Title
Beck Scale for Suicidal Ideation (SSI)
Description
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants will be at least 18 years of age. Participants will meet criteria for Major Depressive Disorder (MDD) on the Structured Clinical Interviews for Axis I DSM-IV Disorders Participants must report current suicidal ideation on the Self-Injurious Thoughts and Behaviors Interview 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). English language proficiency. Exclusion Criteria: DSM-IV diagnosis of bipolar disorder, schizophrenia, psychotic disorder NOS, or personality disorders. Active current substance dependence. Severe or unstable medical conditions that would prohibit regular group attendance or participation. Other group therapy. Significant dementia or cognitive impairment that would interfere with the learning of DBT skills.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurizio Fava, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maren Nyer, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18277222
Citation
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.
Results Reference
background
PubMed Identifier
20424092
Citation
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.
Results Reference
background

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

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