NCT00685451

Brief Summary

The purpose of this phase of the study is to assess the feasibility of a cognitive behavioral therapy for post-traumatic stress disorder (PTSD) in persons receiving outpatient services at an addiction treatment program. The next phase of the study will be a more rigorous investigation of the efficacy of the PTSD therapy within addiction treatment settings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2004

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
Last Updated

September 29, 2011

Status Verified

September 1, 2011

Enrollment Period

1.7 years

First QC Date

May 23, 2008

Last Update Submit

September 28, 2011

Conditions

Keywords

cognitive behavior therapyaddictionPTSD

Outcome Measures

Primary Outcomes (3)

  • decrease in substance use at post-therapy and 3 month follow-up

  • reduction in PTSD symptoms at post-therapy and 3 month follow-up

  • improvement in addiction treatment retention

Secondary Outcomes (4)

  • examine impact of depression, anxiety, and borderline personality disorder on outcomes

  • explore impact of motivation and treatment readiness on outcomes

  • assess overall level of satisfaction with treatment on outcomes

  • examine impact of other services received on outcomes

Interventions

Eligibility Criteria

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

You may qualify if:

  • At least 18 years old;
  • Actively enrolled in intensive outpatient addiction services;
  • Diagnosis of PTSD; and
  • Willing and able to provide informed consent.

You may not qualify if:

  • Acute psychotic disorder;
  • Psychiatric hospitalization or suicide attempt in the past 2 months;
  • Known impending court appearance or legal circumstance that may result in incarceration within next 8 months; and
  • Known medical condition that would likely cause study withdrawal in the next 8 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fresh Start at Concord Hospital

Concord, New Hampshire, 03301, United States

Location

Farnum Center

Manchester, New Hampshire, 03104, United States

Location

Quitting Time

Wilder, Vermont, 05088, United States

Location

MeSH Terms

Conditions

Combat DisordersSubstance-Related DisordersBehavior, AddictiveStress Disorders, Post-Traumatic

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersChemically-Induced DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Mark P. McGovern, Ph.D.

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 23, 2008

First Posted

May 28, 2008

Study Start

November 1, 2004

Primary Completion

August 1, 2006

Study Completion

November 1, 2006

Last Updated

September 29, 2011

Record last verified: 2011-09

Locations