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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Stockholm, Suède, 17177
- Karolinska Institutet
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Modified prolonged exposure therapy
Participants will receive three sessions of modified prolonged exposure therapy.
|
Participants will receive three sessions of modified prolonged exposure therapy.
|
|
Comparateur placebo: Attention control
Participants will receive three sessions of supportive counselling and psychoeducation
|
Participants will receive three sessions of supportive counselling and psychoeducation
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)
Délai: 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)
Délai: 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)
Délai: Measured 6 months after intervention
|
Measure of general health and quality of life
|
Measured 6 months after intervention
|
|
WHO Disability Assessment Schedule (WHODAS)
Délai: 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
Délai: 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)
Délai: Change at week 1, week 2 and week 3
|
Ratings of distress
|
Change at week 1, week 2 and week 3
|
|
Intrusion diary
Délai: 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)
Délai: 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)
Délai: 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)
Délai: Measured at 6 (primary endpoint) months after the intervention
|
Self-report measure on societal costs
|
Measured at 6 (primary endpoint) months after the intervention
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- EPN 2015/1820-31
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .