Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder
Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder: An Randomized Controlled Trial in the Acute Trauma Care
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
-
Stockholm, Sverige, 17177
- Karolinska Institutet
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Modified prolonged exposure therapy
Participants will receive three sessions of modified prolonged exposure therapy.
|
Participants will receive three sessions of modified prolonged exposure therapy.
|
|
Placebo komparator: Attention control
Participants will receive three sessions of supportive counselling and psychoeducation
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Participants will receive three sessions of supportive counselling and psychoeducation
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)
Tidsramme: 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
|
Change 2-, 6- (primary endpoint) and 12 months after intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)
Tidsramme: Change 2-, 6- (primary endpoint) and 12 months after intervention
|
Self-report questionnaire for the assessment of PTSD severity
|
Change 2-, 6- (primary endpoint) and 12 months after intervention
|
|
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
Tidsramme: Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention
|
Self-report questionnaire for the assessment of severity of depression
|
Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention
|
|
Euroqol (EQ-5D)
Tidsramme: Measured 6 months after intervention
|
Measure of general health and quality of life
|
Measured 6 months after intervention
|
|
WHO Disability Assessment Schedule (WHODAS)
Tidsramme: Change 2-, 6- (primary endpoint) and 12 months after intervention
|
Measure of general health and function
|
Change 2-, 6- (primary endpoint) and 12 months after intervention
|
|
Adverse events
Tidsramme: Change 2-, 6- (primary endpoint) and 12 months after intervention
|
Measure of number adverse events
|
Change 2-, 6- (primary endpoint) and 12 months after intervention
|
|
Subjective unit of distress scale (SUD)
Tidsramme: Change at week 1, week 2 and week 3
|
Ratings of distress
|
Change at week 1, week 2 and week 3
|
|
Intrusion diary
Tidsramme: Change at week 1, week 2 and week 3
|
A self-report diary on number of intrusions
|
Change at week 1, week 2 and week 3
|
|
Insomnia Severity Index (ISI)
Tidsramme: Change 2-, 6- (primary endpoint) and 12 months after intervention
|
Self-report questionnaire regarding insomnia
|
Change 2-, 6- (primary endpoint) and 12 months after intervention
|
|
Multidimensional Scale of Perceived Social Support (MSPSS)
Tidsramme: Change 2-, 6- (primary endpoint) and 12 months after intervention
|
A measure to assess for social support
|
Change 2-, 6- (primary endpoint) and 12 months after intervention
|
|
Trimbos Institute of costs in psychiatry (TIC-P)
Tidsramme: Measured at 6 (primary endpoint) months after the intervention
|
Self-report measure on societal costs
|
Measured at 6 (primary endpoint) months after the intervention
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EPN 2015/1820-31
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