Completed

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

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What is being tested

Dialectical Behavior Therapy Skills (DBT-S) Groups

+ Wait List-Treatment as Usual

+ No intervention-treatment as usual

Behavioral
Who is being recruted

Behavior+6

+ Mental Disorders

+ Behavioral Symptoms

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: October 2011
See protocol details

Summary

Principal SponsorMaurizio Fava, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2011

Actual date on which the first participant was enrolled.

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.

Official TitleAdaptation of Dialectical Behavior Therapy Skills-Groups for Individuals With Suicidal Ideation and Depression
NCT01441258
Principal SponsorMaurizio Fava, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

26 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersBehavioral SymptomsDepressive Disorder, MajorDepressive DisorderSuicideSelf-Injurious BehaviorMood DisordersSuicidal Ideation

Criteria

5 inclusion criteria required to participate
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).
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5 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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 II

Placebo
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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Massachusetts General Hospital

Boston, United StatesOpen Massachusetts General Hospital in Google Maps
CompletedOne Study Center
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