Condition category
Mental and Behavioural Disorders
Date applied
18/01/2019
Date assigned
06/03/2019
Last edited
06/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 is expected to run until 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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Åsa Magnusson

ORCID ID

http://orcid.org/0000-0002-4263-1957

Contact details

Rosenlunds sjukhus
EWA-mottagningen
Box 179 03
Stockholm
118 95
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

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.

Acronym

The COPE & RP study

Study hypothesis

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

Stockholm Ethical Review Board, 13/04/2016, ref. 2016/4:4, 2016-06-22, 2016/1250-32.

Study design

A multi-center randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Drug names

Primary outcome measure

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 outcome measures

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 nine months post baseline.

Overall trial start date

25/01/2016

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

150

Participant 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

Recruitment start date

13/04/2016

Recruitment end date

31/12/2020

Locations

Countries of recruitment

Sweden

Trial participating centre

The EWA unit at The Stockholm Centre for Depencency Disorders
Rosenlunds sjukhus EWA-mottagningen Box 179 03
Stockholm
11895
Sweden

Trial participating centre

PRIMA Maria Oppenvård
Wollmar Yxkullsgatan 25, 1 tr
Stockholm
118 50
Sweden

Trial participating centre

Universitetssjukhuset i Linkoping
CSAN, Psykiatriska kliniken, ingang 27, plan 9, Universitetssjukhuset
Linkoping
581 85
Sweden

Sponsor information

Organisation

Åsa Magnusson

Sponsor details

Rosenlunds sjukhus
EWA-mottagningen
Box 179 03
Stockholm
118 95
Sweden

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research council

Funder name

Systembolagets Alkoholforskningsrad

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Stiftelsen Soderstrom-Konigska Sjukhemmet

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Karolinska Institutet/Stockholm County Council

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Psykiatrifonden

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Once the study is completed a manuscript outlining it and its results will be submitted for publication in a peer-reviewed journal.

IPD sharing statement: 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.

Intention to publish date

31/03/2022

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes