NCT01127932

Brief Summary

This is a 2-year study designed to: (1) adapt and refine an existing cognitive-behavioral treatment (CBT) intervention to decrease suicidal thoughts and behaviors for use in Substance Use Disorder (SUD) treatment settings, and (2) conduct a pilot randomized controlled trial with 50 patients in treatment for SUDs comparing the CBT intervention to an enhanced control condition. Through this pilot randomized controlled trial, the investigators hope to not only obtain information about the feasibility of implementing these procedures in residential SUD treatment, but to also determine whether this intervention decreases the level of suicidal ideation, suicide attempts, hopelessness, and frequency of substance use relative to the control condition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

May 13, 2015

Status Verified

May 1, 2015

Enrollment Period

1.2 years

First QC Date

May 20, 2010

Last Update Submit

May 11, 2015

Conditions

Keywords

Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

  • Level of Suicidal Ideation

    Six months

Study Arms (2)

CBT for suicide

EXPERIMENTAL
Behavioral: CBT for suicide in Substance abuse

Enhanced care control group

ACTIVE COMPARATOR

This group is designed to be an active control which provides detailed information about substance use, suicide risk, and depression without providing any CBT or other specific therapy.

Behavioral: Psychoeducation for substance abuse

Interventions

This active control provides detailed information about substance use, suicide risk, and depression to those enrolled.

Enhanced care control group

The therapeutic intervention group is designed to provide beneficial coping strategies that are helpful in dealing with both substance use and suicidal thoughts.

CBT for suicide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be over 18 years of age
  • Report a past lifetime suicide attempt
  • Report current suicidal ideation
  • Resided in treatment for less than 4 weeks
  • In treatment for less than 6 months

You may not qualify if:

  • Mental incompetence (e.g. unable to provide informed consent)
  • Diagnosis of schizophrenia or currently psychotic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Programs, INC.

Waterford, Michigan, 48327, United States

Location

MeSH Terms

Conditions

SuicideSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

May 20, 2010

First Posted

May 21, 2010

Study Start

April 1, 2010

Primary Completion

July 1, 2011

Study Completion

September 1, 2011

Last Updated

May 13, 2015

Record last verified: 2015-05

Locations