ClinicalTrials.Veeva

Menu

Present- Versus Past-focused Therapy for PTSD and Substance Use Disorder

V

Veterans Affairs (VA) Boston Healthcare System

Status

Completed

Conditions

Posttraumatic Stress Disorder
Substance Use Disorder
Alcohol Use Disorder

Treatments

Behavioral: Seeking Safety (SS)
Behavioral: Creating Change (CC)

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01274741
SPLA-CX000308-01 (VA CSRD)

Details and patient eligibility

About

This study compares Creating Change, a new past-focused behavioral therapy for posttraumatic stress disorder (PTSD)/substance use disorder (SUD), to Seeking Safety, an evidence-based present-focused behavioral therapy for PTSD/SUD.

Full description

This study evaluates a new behavioral therapy model, Creating Change (CC) for PTSD/SUD. CC helps clients explore the past as a step in their recovery process. It has major public health relevance in that it is a low-cost, flexible model designed for all trauma and substance abuse types, both genders, and all clinical settings. It has particular relevance for VA in that many veterans suffer from PTSD and SUD. The new model demonstrated positive results in two pilot studies.

Enrollment

52 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Meet Diagnostic and Statistical Manual (DSM-IV) criteria for current PTSD and current substance use disorder
  • Have used a substance in the 60 days prior to intake
  • Outpatient
  • Plan to stay in Boston for the next 6 months
  • If on psychiatric medication, are on a stable regimen for at least 4 weeks prior to participation in the study
  • Have a stable mailing address and live nearby enough to come to VA Boston for treatment
  • Able to sign informed consent
  • Willing to participate in all assessments and urine testing
  • Willing to provide a release of information for study staff to contact treaters as needed for clinical concerns

Exclusion criteria

  • Any current acute medical condition that would either interfere with the patient's ability to attend treatment, or would be of such severity as to affect the patient's psychological functioning
  • Current bipolar I disorder, schizophrenia or other psychotic disorders, mental retardation, or organic mental disorder
  • Any obvious clinical sign that the patient is not sufficiently stable to participate in the treatment, or notification by the patient's primary providers that participation would be contraindicated
  • Dangerousness that would present a threat to staff or patients (e.g., history of assault within the past 6 months)
  • The patient is mandated to treatment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

52 participants in 2 patient groups

Seeking Safety (SS)
Active Comparator group
Description:
17 sessions of present-focused therapy Seeking Safety
Treatment:
Behavioral: Seeking Safety (SS)
Creating Change (CC)
Experimental group
Description:
17 sessions of past-focused Creating Change
Treatment:
Behavioral: Creating Change (CC)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems