Post-traumatic stress disorder and alcohol use disorder Mental and Behavioural Disorders Post-traumatic stress disorder and Mental and behavioural disorders due to use of alcohol
Conditions
Interventions
12 sessions of Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE), integrated cognitive behavioural therapy (CBT) for PTSD and substance use disorders (SUD) will
Sponsors
Rosenlunds sjukhus [Rosenlund Hospital]
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female 2. Aged 18 years or older 3. Current PTSD and moderate to severe AUD, according to DSM-5 and clinical assessment
Exclusion criteria
Exclusion criteria: 1. Current moderate to severe SUD, other than alcohol and nicotine, according to DSM-5 2. Current or not stably treated psychosis 3. Suicidal or homicidal ideation deemed to be in need of treatment before study treatment can start 4. Current medication, which may affect the study outcome, and which is deemed impossible to discontinue for the duration of the study, primarily AUD medication 5. Insufficient memory of the trauma (assessed using the CAPS-5) 6. Dissociation which is more difficult or affects the subject more than her PTSD 7. Somatic or psychiatric illness where it is deemed to not be in the subject’s best interest to participate in the study 8. IQ < 70
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. PTSD symptom severity will be measured using the Clinician-Administered PTSD Scale (CAPS-5) at baseline, sessions 6 and 12 and six and nine months post baseline. 2. Alcohol consumption per week (grams per week) and heavy drinking days (HDD) will be measured using the Timeline Follow Back (TLFB) at baseline, sessions 6 and 12 and six and nine months post baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. AUD symptom severity will be measured using the AUD section of the MINI International Neuropsychiatric Interview (MINI) at baseline, sessions 6 and 12 and six and nine months post baseline. 2. Biomarkers of alcohol use (phosphatidylethanol (PEth), aspartate amino transferase (ASAT), alanine amino transferase (ALAT), gamma glutamyl transpeptidase (GGT), mean corpuscular volume (MCV) will be measured using blood samples at baseline, sessions 6 and 12 and six and nine months post baseline. 3. Biomarkers of stress (cortisol in hair) will be measured using hair samples at baseline, session 12 and six and nine months post baseline. 4. The association between genetic variation (e.g. CNR1, FAAH) and treatment response will be measured using blood samples at baseline. 5. Functioning in important areas such as work and relationships will be measured using the Addiction Severity Index – Self Report Form (ASI-SR) at baseline, session 12 and six and nine months post baseline. 6. The effect of treatment on health care consumption will be measured using the Questionnaire on Medical consumption and Productivity losses associated with Psychiatric Illness (TiC-P) at baseline, session 12 and six and nine months post baseline. 7. The association between general mental ability (GMA) and treatment response will be measured using the GMA test Matrigma at baseline, session 12 and six and nine months post baseline. 8. The association between personality and treatment response will be measured using NEO Five-Factor Inventory-3 (NEO-FFI-3) at baseline, session 12 and six and nine months post baseline. 9. The association between treatment credibility/expectancy and treatment response will be measured using the Credibility/Expectancy Questionnaire (CEQ) at baseline, sessions 1, 6, 12 and six and nine months post baseline. 10. The association between working alliance and treatment response will be measured using the Working Alliance Inventory (WAI-S) at baseline, sessions 1, 6, 12 and six and | — |
Countries
Sweden
Outcome results
None listed