Treating PTSD and alcohol use disorder simultaneously
| ISRCTN | ISRCTN61391164 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61391164 |
| Protocol serial number | 1 |
| Sponsor | Rosenlunds sjukhus [Rosenlund Hospital] |
| Funders | Systembolagets Alkoholforskningsrad, Stiftelsen Soderstrom-Konigska Sjukhemmet, Karolinska Institutet/Stockholm County Council, Psykiatrifonden |
- Submission date
- 18/01/2019
- Registration date
- 06/03/2019
- Last edited
- 16/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Posttraumatic stress disorder (PTSD) is triggered by severe trauma. It is characterized by intrusive memories or nightmares, avoidance, hyperarousal and negative changes in cognition and mood. PTSD is common and occurs more often in women than in men (8-16 vs 4-8%). PTSD often occurs simultaneously with alcohol dependence (AD), also referred to as moderate to severe alcohol use disorder (AUD). There is effective treatment for PTSD. Prolonged exposure (PE) is one such effective treatment for PTSD. It is a manual based treatment, a type of trauma focused cognitive behavioral therapy (CBT). It has been adapted for individuals with both PTSD and substance use disorders (SUD). This new treatment is called “Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure" (COPE) and combines PE with CBT for SUD, i.e. relapse prevention (RP). RP is frequently used in the treatment of AUD.
The overall aim of this research project is to evaluate COPE in out-patient care for women with PTSD and moderate to severe AUD. The study evaluates the hypothesis that COPE will lead to greater reductions in PTSD and AUD symptom severity than RP, i.e. that COPE will be better than RP.
Who can participate?
Up to one hundred and fifty treatment-seeking women, aged >18, diagnosed with current PTSD and moderate to severe AUD will be recruited.
What does the study involve?
The study consists of three consecutive phases for each participant:
1. Screening and randomization, carried out over the course of three to four visits, including diagnostic assessment and randomization to receive COPE or RP,
2. CBT, 12 sessions of COPE or 12 sessions of RP, typically one a week,
3. follow-ups, at sessions 6 and 12, and six and nine months post baseline.
What are the possible benefits and risks of participating?
Participants will receive treatment for PTSD and AUD (COPE) or AUD (RP) respectively and their symptoms will be carefully monitored. Should further treatment be necessary post study treatment, such treatment or a referral to another health care provider will be provided. Previous studies have shown these treatments to be safe and effective, but side effects such as temporarily worsening symptoms may occur. Should this occur, staff at the study site will
provide care and support.
Where is the study run from?
The study is run from the EWA unit and PRIMA Maria in Stockholm and the University hospital in Linkoping, Sweden. The EWA unit is the lead centre.
When is the study starting and how long is it expected to run for?
The study started in 2016 and ran until May 2021.
Who is funding the study?
The study is funded by research grants from Systembolagets Alkoholforskningsrad, Stiftelsen Soderstrom-Konigska Sjukhemmet, Karolinska Institutet/Stockholm County Council, Psykiatrifonden.
Who is the main contact?
Asa Magnusson, sponsor, principal investigator, PhD, psychiatrist, is the main contact. She can be reached at asa.magnusson@ki.se
Contact information
Scientific
Rosenlunds sjukhus
EWA-mottagningen
Box 179 03
Stockholm
118 95
Sweden
 ORCID ID |
0000-0002-4263-1957 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A multi-center randomised controlled trial. |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomized controlled trial of Concurrent treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE) and Relapse Prevention (RP) in women with PTSD and Alcohol Use Disorder. |
| Study acronym | The COPE & RP study |
| Study objectives | Our hypotheses are: 1. That COPE will reduce PTSD symptoms more than relapse prevention (RP), i.e. that COPE will be better than RP 2. That COPE will reduce alcohol consumption more than RP, i.e. that COPE will be better than RP The co-primary objectives of the study are to determine whether COPE, in women with co-morbid PTSD and moderate to severe AUD, will: 1. Reduce PTSD symptoms, measured as change from baseline, to sessions 6 and 12 and six and nine months after baseline, compared to RP (measured using the Clinician-Administered PTSD Scale (CAPS)) 2. Reduce alcohol use, measured as change from baseline in alcohol consumption per week (grams per week) and heavy drinking days (HDD) from baseline to session 6 and 12 and six and nine months after baseline, compared to RP (measured using the Time Line Follow Back (TLFB)) |
| Ethics approval(s) | Stockholm Ethical Review Board, 13/04/2016, ref. 2016/4:4, 2016-06-22, 2016/1250-32. |
| Health condition(s) or problem(s) studied | Post-traumatic stress disorder and alcohol use disorder |
| Intervention | 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 be compared with control 12 sessions of relapse prevention (RP), i.e. CBT for SUD. The twelve sessions are to be delivered weekly, but may be given over a maximum of 20 weeks. Follow-ups will occur at sessions 6 and 12 as well as six and nine months post baseline. Participants will be randomised 1:1 to the different arms. Randomisation is provided by an organization independent from the researchers. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 10/05/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 150 |
| Total final enrolment | 90 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 13/04/2016 |
| Date of final enrolment | 31/12/2020 |
Locations
Countries of recruitment
- Sweden
Study participating centres
EWA-mottagningen
Box 179 03
Stockholm
11895
Sweden
Stockholm
118 50
Sweden
Linkoping
581 85
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be available as the current ethics approval does not allow it. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/07/2025 | 16/07/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/07/2025: Publication reference added.
29/12/2021: The following changes have been made:
1. The total final enrolment has been added.
2. The overall trial end date has been changed from 31/12/2021 to 10/05/2021 and the plain English summary updated accordingly.
06/01/2020: Internal review.
