Posttraumatic Stress DisorderNCT01274741
Present- Versus Past-focused Therapy for PTSD and Substance Use Disorder
A study testing Creating Change (CC) and Seeking Safety (SS) in people with Posttraumatic Stress Disorder and Substance Use Disorder, run by VA Boston Healthcare System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder, Substance Use Disorder, Alcohol Use Disorder
- What is being tested?
- Creating Change (CC) and Seeking Safety (SS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System
Boston, Massachusetts, 02459
About this study
Official title: Pilot Study of an Integrated Exposure-Based Model for Posttraumatic Stress Disorder and Substance Use Disorder
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.
Read the detailed 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.
- Being tested
- Creating Change (CC), Seeking Safety (SS)
- Keywords
- Posttraumatic stress disorder, Substance use disorder, Treatment efficacy, Randomized trial, Trauma, Substance abuse, Addiction
- Medical subject headings
- Stress Disorders, Post-Traumatic, Substance-Related Disorders, Alcoholism, Wounds and Injuries, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creating Change (CC)Behavioural
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.
Seeking Safety (SS)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Seeking Safety (SS) | Active comparator | 17 sessions of present-focused therapy Seeking Safety Receives: Behavioral: Seeking Safety (SS) |
| Creating Change (CC) | Experimental | 17 sessions of past-focused Creating Change Receives: Behavioral: Creating Change (CC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Checklist total score - from baseline through end of treatment and 3-month followup
PTSD symptoms assessed via self-report measure
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Self-report measure
Measured: 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
Self-report measure
Measured: 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
Self-report measure
Measured: 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
Self-report measure
Measured: 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
Self-report measure
Measured: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
Change in World Assumptions Scale - from baseline through end of treatment and 3-month followup
Self-report measure
Measured: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
Change in Trauma Related Guilt Inventory - from baseline through end of treatment and 3-month followup
Self-report measure
Measured: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Boston Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Karen Krinsley, VA Boston Healthcare System
- Investigators
- Karen E. Krinsley, Ph.D., Principal investigator, VA Boston Healthcare SystemLisa M Najavits, PhD, Principal investigator, VA Boston Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274741
- Sponsor's protocol ID
- SPLA-CX000308-01 (VA CSRD)
- Status last verified
- May 2019
- First submitted
- 10 Jan 2011
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 29461920
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of an Integrated Exposure-Based Model for Posttraumatic Stress Disorder and Substance Use Disorder
- ClinicalTrials.gov ID
- NCT01274741
- Acronym / sponsor ID
- SPLA-CX000308-01 (VA CSRD)
- Keywords
- Posttraumatic stress disorder, Substance use disorder, Treatment efficacy, Randomized trial, Trauma, Substance abuse, Addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- VA Boston Healthcare SystemUS federal agency
- Study start
- Jan 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seeking Safety (SS) | Active comparator | Behavioral: Seeking Safety (SS)17 sessions of present-focused therapy Seeking Safety |
| Creating Change (CC) | Experimental | Behavioral: Creating Change (CC)17 sessions of past-focused Creating Change |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creating Change (CC)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. | Behavioural | Creating Change (CC) |
| Seeking Safety (SS)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. | Behavioural | Seeking Safety (SS) |
Primary outcome
Change in PTSD Checklist total score - from baseline through end of treatment and 3-month followup
Time frame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
PTSD symptoms assessed via self-report measure
Change in diagnosis of PTSD on the MINI Neuropsychiatric Interview - from baseline through end of treatment and 3-month followup
Time frame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
PTSD diagnosis as assessed by a trained interviewer
Change in Addiction Severity Index alcohol composite score - from baseline through end of treatment and 3-month followup
Time frame: Baseline, end of treatment (approximately 4 months from baseline), 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.
Change in Addiction Severity Index drug composite score - from baseline through end of treatment and 3-month followup
Time frame: Baseline, end of treatment (approximately 4 months from baseline), 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.
7 secondary outcomes
Change in Quality of Life Satisfaction & Enjoyment Scale - from baseline through end of treatment and 3-month followup
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
Change in World Assumptions Scale - from baseline through end of treatment and 3-month followup
Time frame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
Change in Trauma Related Guilt Inventory - from baseline through end of treatment and 3-month followup
Time frame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Results publication: PubMed 29461920Najavits 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.
- Individual participant dataSharing planned: No
Related trials for Posttraumatic Stress Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
Not yet recruiting
Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use
Post Traumatic Stress Disorder PTSD, Hazardous Alcohol Use
Not yet recruitingPhase 2
Written Exposure Therapy Plus Adjunctive Methylphenidate Treatment for Veterans With PTSD
PTSD - Post Traumatic Stress Disorder
Recruiting
Recovering Sleep After Trauma
Post-traumatic Stress Disorder
Recruiting
Evaluating Evidenced Based Options for PTSD Treatment
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen E. Krinsley, Ph.D. principal investigator
VA Boston Healthcare System
Lisa M Najavits, PhD principal investigator
VA Boston Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creating Change (CC) and Seeking Safety (SS) in people with Posttraumatic Stress Disorder and Substance Use Disorder, run by VA Boston Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD Checklist total score - from baseline through end of treatment and 3-month followup (time frame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01274741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.