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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seeking Safety (SS) | Active Comparator | 17 sessions of present-focused therapy Seeking Safety |
|
| Creating Change (CC) | Experimental | 17 sessions of past-focused Creating Change |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life Satisfaction & Enjoyment Scale - 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 Brief Symptom Inventory-Global Severity Index - from baseline through end of treatment and 3-month followup |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen E. Krinsley, Ph.D. | VA Boston Healthcare System | Principal Investigator |
| Lisa M Najavits, PhD | VA Boston Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Boston Healthcare System | Boston | Massachusetts | 02459 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29461920 | Result | 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. |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D019966 | Substance-Related Disorders |
| D000437 | Alcoholism |
| D014947 | Wounds and Injuries |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D064419 | Chemically-Induced Disorders |
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|
| 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. |
|
Self-report measure |
| 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 | 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 | 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 | 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 | 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 | Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup |
| D019973 | Alcohol-Related Disorders |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |