NCT01274741

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

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

January 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 3, 2019

Status Verified

May 1, 2019

Enrollment Period

4.2 years

First QC Date

January 10, 2011

Last Update Submit

May 2, 2019

Conditions

Posttraumatic Stress DisorderSubstance Use DisorderAlcohol Use Disorder

Keywords

Posttraumatic stress disorderSubstance use disorderTreatment efficacyRandomized trialTraumaSubstance abuseAddiction

Outcome Measures

Primary Outcomes (4)

  • Change in PTSD Checklist total score - from baseline through end of treatment and 3-month followup

    PTSD symptoms assessed via self-report measure

    Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup

  • Change in diagnosis of PTSD on the MINI Neuropsychiatric Interview - from baseline through end of treatment and 3-month followup

    PTSD diagnosis as assessed by a trained interviewer

    Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup

  • Change in Addiction Severity Index alcohol composite score - from baseline through end of treatment and 3-month followup

    Alcohol use and associated problems as measured by blinded-interviewer measure Composite. These outcome variables will be measured at baseline, end of treatment and 3-month followup.

    Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup

  • Change in Addiction Severity Index drug composite score - from baseline through end of treatment and 3-month followup

    Drug use and associated problems as measured by blinded-interviewer measure Composite. These outcome variables will be measured at baseline, end of treatment and 3-month followup. Urinanlysis/breathalyzer will be obtained to verify ASI self-report.

    Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup

Secondary Outcomes (7)

  • Change in Quality of Life Satisfaction & Enjoyment Scale - from baseline through end of treatment and 3-month followup

    Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup

  • Change in Brief Symptom Inventory-Global Severity Index - from baseline through end of treatment and 3-month followup

    Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup

  • Change in Beliefs About Substance Use - from baseline through end of treatment and 3-month followup

    Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup

  • Change in General Self-Efficacy - from baseline through end of treatment and 3-month followup: Self-report measure

    Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup

  • Change in Coping Self-Efficacy Scale - from baseline through end of treatment and 3-month followup

    Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup

  • +2 more secondary outcomes

Study Arms (2)

Seeking Safety (SS)

ACTIVE COMPARATOR

17 sessions of present-focused therapy Seeking Safety

Behavioral: Seeking Safety (SS)

Creating Change (CC)

EXPERIMENTAL

17 sessions of past-focused Creating Change

Behavioral: Creating Change (CC)

Interventions

Creating Change (CC)BEHAVIORAL

Creating Change is a past-focused, integrated, cognitive-behavioral therapy for PTSD/SUD. It has 17 topics, which in this study were delivered in weekly one-hour sessions, in individual format. The treatment explores how PTSD and SUD arose and interacted across the patient's life, including constructing a narrative of its meaning, processing associated emotions and memories, and exploring themes related to these.

Creating Change (CC)
Seeking Safety (SS)BEHAVIORAL

Seeking Safety is a present-focused, evidence-based cognitive-behavioral therapy for integrated treatment of patients with PTSD/SUD. It is a cognitive-behavioral therapy comprising 25 topics, each a coping skill relevant to both disorders. In this study 17 of the 25 topics were conducted, one per weekly, one-hour, individual session.

Seeking Safety (SS)

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System

Boston, Massachusetts, 02459, United States

Location

Related Publications (1)

  • Najavits LM, Krinsley K, Waring ME, Gallagher MW, Skidmore C. A Randomized Controlled Trial for Veterans with PTSD and Substance Use Disorder: Creating Change versus Seeking Safety. Subst Use Misuse. 2018 Sep 19;53(11):1788-1800. doi: 10.1080/10826084.2018.1432653. Epub 2018 Feb 20.

    PMID: 29461920RESULT

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticSubstance-Related DisordersAlcoholismWounds and InjuriesBehavior, Addictive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Karen E. Krinsley, Ph.D.

    VA Boston Healthcare System

    PRINCIPAL INVESTIGATOR

  • Lisa M Najavits, PhD

    VA Boston Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PTSD Section Chief

Study Record Dates

First Submitted

January 10, 2011

First Posted

January 11, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 3, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)