Post Traumatic Stress DisorderNCT03116165
Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder
A study testing Modified prolonged exposure therapy in people with Post Traumatic Stress Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This study will examine the use of modified prolonged exposure therapy in trauma patients recently exposed to trauma in an emergency room to prevent the onset of post-traumatic stress disorder. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Modified prolonged exposure therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 352 participants
- Where
- 1 siteSweden
- Study dates
- 18 Apr 2017to 11 Dec 2017
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Presenting to the emergency department at the Karolinska University hospital Solna in the past 72 hours before the intervention
- Meets diagnostic criterion A for post-traumatic stress disorder in the fifth version of Diagnostic and Statistical Manual of Mental Disorders, DSM-5
Who cannot join
- Do not want to participate in the study
- Ongoing intoxication (e.g. severe alcohol intoxication)
- Other serious psychiatric comorbidity that demands attention (e.g. manic episode, acute suicidal ideation)
- Not oriented
- Not having a memory ot the tramatic event
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder: An Randomized Controlled Trial in the Acute Trauma Care
This study will examine the use of modified prolonged exposure therapy in trauma patients recently exposed to trauma in an emergency room to prevent the onset of post-traumatic stress disorder.
Read the detailed description
This study investigates if prolonged exposure is an effective treatment in reducing PTSD symptoms people who have recently experienced trauma. The study will also investigate predictive markers of PTSD, moderators of successful treatment and health economic aspects of the intervention.
Participants will first undergo an evaluation session that will include an interview (Immediate Stress Reaction Checklist) and questionnaires. Participants will subsequently be randomly assigned to receive either modified prolonged exposure therapy or attention control, starting the assigned intervention immediately. Participants in each arm will receive three weekly treatment sessions. Treatment will involve psychoeducation about common reactions to trauma, imaginal exposure (revisiting memories of a recent trauma out loud with a therapist and audio-recording these for review at home), exposure in vivo and breathing retraining. All participants will undergo assessments 2, 6 (primary endpoint) and 12 months after the intervention by blinded assessors. Patients unable to come to the clinic for follow-up assessments will be interviewed via telephone or skype. Source data will be quality monitored by an independent party (Karolinska trial alliance) according to the Helsinki Declaration.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Modified prolonged exposure therapy, Attention control
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified prolonged exposure therapyBehavioural
Participants will receive three sessions of modified prolonged exposure therapy.
Attention controlBehavioural
Participants will receive three sessions of supportive counselling and psychoeducation
| Study group | Role | What they receive |
|---|---|---|
| Modified prolonged exposure therapy | Experimental | Participants will receive three sessions of modified prolonged exposure therapy. Receives: Behavioral: Modified prolonged exposure therapy |
| Attention control | Placebo comparator | Participants will receive three sessions of supportive counselling and psychoeducation Receives: Behavioral: Attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)
Clinical interview that gives a continuous measure of PTSD severity and dichotomous diagnosis of PTSD
Measured: Change 2-, 6- (primary endpoint) and 12 months after intervention
Secondary outcomes (10)
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)
Self-report questionnaire for the assessment of PTSD severity
Measured: Change 2-, 6- (primary endpoint) and 12 months after intervention
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
Self-report questionnaire for the assessment of severity of depression
Measured: Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention
Euroqol (EQ-5D)
Measure of general health and quality of life
Measured: Measured 6 months after intervention
WHO Disability Assessment Schedule (WHODAS)
Measure of general health and function
Measured: Change 2-, 6- (primary endpoint) and 12 months after intervention
Adverse events
Measure of number adverse events
Measured: Change 2-, 6- (primary endpoint) and 12 months after intervention
Subjective unit of distress scale (SUD)
Ratings of distress
Measured: Change at week 1, week 2 and week 3
Intrusion diary
A self-report diary on number of intrusions
Measured: Change at week 1, week 2 and week 3
Insomnia Severity Index (ISI)
Self-report questionnaire regarding insomnia
Measured: Change 2-, 6- (primary endpoint) and 12 months after intervention
Multidimensional Scale of Perceived Social Support (MSPSS)
A measure to assess for social support
Measured: Change 2-, 6- (primary endpoint) and 12 months after intervention
Trimbos Institute of costs in psychiatry (TIC-P)
Self-report measure on societal costs
Measured: Measured at 6 (primary endpoint) months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start18 Apr 2017
- Primary completion11 Dec 2017
- Study completion11 Dec 2017
Why it stopped: Organisational changes in hospital which changed recruitment rates
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Andersson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116165
- Sponsor's protocol ID
- EPN 2015/1820-31
- Status last verified
- May 2018
- First submitted
- 3 Apr 2017
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder: An Randomized Controlled Trial in the Acute Trauma Care
- ClinicalTrials.gov ID
- NCT03116165
- Acronym / sponsor ID
- EPN 2015/1820-31
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Organisational changes in hospital which changed recruitment rates
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 11 Dec 2017 (actual)
- Study completion
- 11 Dec 2017 (actual)
- First posted
- 14 Apr 2017 (actual)
- 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 will examine the use of modified prolonged exposure therapy in trauma patients recently exposed to trauma in an emergency room to prevent the onset of post-traumatic stress disorder.
Detailed description
This study investigates if prolonged exposure is an effective treatment in reducing PTSD symptoms people who have recently experienced trauma. The study will also investigate predictive markers of PTSD, moderators of successful treatment and health economic aspects of the intervention.
Participants will first undergo an evaluation session that will include an interview (Immediate Stress Reaction Checklist) and questionnaires. Participants will subsequently be randomly assigned to receive either modified prolonged exposure therapy or attention control, starting the assigned intervention immediately. Participants in each arm will receive three weekly treatment sessions. Treatment will involve psychoeducation about common reactions to trauma, imaginal exposure (revisiting memories of a recent trauma out loud with a therapist and audio-recording these for review at home), exposure in vivo and breathing retraining. All participants will undergo assessments 2, 6 (primary endpoint) and 12 months after the intervention by blinded assessors. Patients unable to come to the clinic for follow-up assessments will be interviewed via telephone or skype. Source data will be quality monitored by an independent party (Karolinska trial alliance) according to the Helsinki Declaration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified prolonged exposure therapy | Experimental | Behavioral: Modified prolonged exposure therapyParticipants will receive three sessions of modified prolonged exposure therapy. |
| Attention control | Placebo comparator | Behavioral: Attention controlParticipants will receive three sessions of supportive counselling and psychoeducation |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Presenting to the emergency department at the Karolinska University hospital Solna in the past 72 hours before the intervention
- Meets diagnostic criterion A for post-traumatic stress disorder in the fifth version of Diagnostic and Statistical Manual of Mental Disorders, DSM-5
Key exclusion criteria (5 listed)
- Do not want to participate in the study
- Ongoing intoxication (e.g. severe alcohol intoxication)
- Other serious psychiatric comorbidity that demands attention (e.g. manic episode, acute suicidal ideation)
- Not oriented
- Not having a memory ot the tramatic event
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 |
|---|---|---|
| Modified prolonged exposure therapyParticipants will receive three sessions of modified prolonged exposure therapy. | Behavioural | Modified prolonged exposure therapy |
| Attention controlParticipants will receive three sessions of supportive counselling and psychoeducation | Behavioural | Attention control |
Primary outcome
CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)
Time frame: Change 2-, 6- (primary endpoint) and 12 months after intervention
Clinical interview that gives a continuous measure of PTSD severity and dichotomous diagnosis of PTSD
10 secondary outcomes
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)
Time frame: Change 2-, 6- (primary endpoint) and 12 months after intervention
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
Time frame: Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention
Euroqol (EQ-5D)
Time frame: Measured 6 months after intervention
WHO Disability Assessment Schedule (WHODAS)
Time frame: Change 2-, 6- (primary endpoint) and 12 months after intervention
Adverse events
Time frame: Change 2-, 6- (primary endpoint) and 12 months after intervention
Subjective unit of distress scale (SUD)
Time frame: Change at week 1, week 2 and week 3
Intrusion diary
Time frame: Change at week 1, week 2 and week 3
Insomnia Severity Index (ISI)
Time frame: Change 2-, 6- (primary endpoint) and 12 months after intervention
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Change 2-, 6- (primary endpoint) and 12 months after intervention
Trimbos Institute of costs in psychiatry (TIC-P)
Time frame: Measured at 6 (primary endpoint) months after the intervention
Results and safety
The study was stopped early (reason given: Organisational changes in hospital which changed recruitment rates). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified prolonged exposure therapy in people with Post Traumatic Stress Disorder, run by Karolinska Institutet at 1 site in Sweden.
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 2 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: stopped early, as of the sponsor's last update on 17 May 2018. 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 Sweden. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Organisational changes in hospital which changed recruitment rates). Results are not available in the source record.
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?
CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS) (time frame: Change 2-, 6- (primary endpoint) and 12 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2018.