- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03116165
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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
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Stockholm, Svezia, 17177
- Karolinska Institutet
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Modified prolonged exposure therapy
Participants will receive three sessions of modified prolonged exposure therapy.
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Participants will receive three sessions of modified prolonged exposure therapy.
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Comparatore placebo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)
Lasso di tempo: Change 2-, 6- (primary endpoint) and 12 months after intervention
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Clinical interview that gives a continuous measure of PTSD severity and dichotomous diagnosis of PTSD
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Change 2-, 6- (primary endpoint) and 12 months after intervention
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)
Lasso di tempo: Change 2-, 6- (primary endpoint) and 12 months after intervention
|
Self-report questionnaire for the assessment of PTSD severity
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Change 2-, 6- (primary endpoint) and 12 months after intervention
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Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
Lasso di tempo: Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention
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Self-report questionnaire for the assessment of severity of depression
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Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention
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Euroqol (EQ-5D)
Lasso di tempo: Measured 6 months after intervention
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Measure of general health and quality of life
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Measured 6 months after intervention
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WHO Disability Assessment Schedule (WHODAS)
Lasso di tempo: 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
Lasso di tempo: Change 2-, 6- (primary endpoint) and 12 months after intervention
|
Measure of number adverse events
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Change 2-, 6- (primary endpoint) and 12 months after intervention
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Subjective unit of distress scale (SUD)
Lasso di tempo: Change at week 1, week 2 and week 3
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Ratings of distress
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Change at week 1, week 2 and week 3
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Intrusion diary
Lasso di tempo: Change at week 1, week 2 and week 3
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A self-report diary on number of intrusions
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Change at week 1, week 2 and week 3
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Insomnia Severity Index (ISI)
Lasso di tempo: Change 2-, 6- (primary endpoint) and 12 months after intervention
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Self-report questionnaire regarding insomnia
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Change 2-, 6- (primary endpoint) and 12 months after intervention
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Multidimensional Scale of Perceived Social Support (MSPSS)
Lasso di tempo: Change 2-, 6- (primary endpoint) and 12 months after intervention
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A measure to assess for social support
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Change 2-, 6- (primary endpoint) and 12 months after intervention
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Trimbos Institute of costs in psychiatry (TIC-P)
Lasso di tempo: Measured at 6 (primary endpoint) months after the intervention
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Self-report measure on societal costs
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Measured at 6 (primary endpoint) months after the intervention
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- EPN 2015/1820-31
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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