Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder (EYIPTSD)
19 marzo 2013 aggiornato da: Sat Bir Khalsa, PhD, Brigham and Women's Hospital
The main objective of this preliminary randomized controlled clinical trial is to establish efficacy and feasibility of a yoga-based treatment for PTSD in military veterans as compared to a delayed yoga treatment (waitlist control) group.
Secondary objectives are to evaluate PTSD characteristics that may also be improved with the treatment and acceptability and compliance with the treatment.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Specific Aims:
- To evaluate the hypothesis that a 10-week yoga-based intervention will reduce PTSD severity to a statistically and clinically significant degree relative to a pretreatment baseline evaluation and to a waitlist control group.
- To evaluate the hypothesis that PTSD patients will show improvement in regulation of physiological arousal in the autonomic nervous system relative to pretreatment.
- To evaluate that hypothesis that symptoms associated with PTSD such as depression, anxiety, insomnia and quality of life will also be improved.
- To evaluate the hypothesis that military veterans with PTSD can be successfully recruited into a yoga intervention study and will find the intervention acceptable and tolerable and will exhibit high compliance.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
108
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02215
- Brigham and Women's Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Male and female military veterans and active duty military personnel aged 18 and older
- A DSM IV diagnosis of post-traumatic stress disorder
- Potential subjects on medications are eligible to participate in the study
- Potential subjects who receive ongoing medical or psychological treatment are eligible to participate in this study as long as these treatments do not include more than one hour weekly of relaxation and mind-body based stress reduction strategies (strategies directly related to meditation and yoga)
- Potential subjects are eligible to participate in this study if they have sufficient mental and physical ability to fully participate in the parameters of the study. Subjects must be able to understand and comply with instructions in the group yoga sessions and home practice, complete questionnaires, participate in clinical interviews, and take part in all data collection activities. Subjects with severe mental or physical concerns that may prevent them from understanding and/or complying with the treatment will be excluded. For example, potential subjects confined to wheelchairs will not be eligible, although subjects with artificial limbs who are able to reasonably participate in the intervention may be deemed eligible. These determinations will be made during discussions with potential subjects on a case by case basis during the screening process
Exclusion Criteria:
- Potential subjects are ineligible if pregnant and in their third trimester.
- Potential subjects are ineligible if they are confined to a wheel chair.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Trattamento yoga
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The 10-week Kripalu-style yoga treatment will consist of 20 biweekly 90-minute group training/practice sessions.
In addition, subjects will also receive CD's and written instructions for the daily 15-minute sessions, which they will use to guide them through the yoga procedures to be done at home.
Altri nomi:
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Nessun intervento: Waitlist
Waitlist control, no active treatment, treatment as usual, active treatment offered after waitlist control period.
This study began as a single arm treatment trial and then transitioned to a randomized controlled trial.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Clinician Administered PTSD Scale (CAPS)
Lasso di tempo: pre-intervention and 10 weeks
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pre-intervention and 10 weeks
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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PTSD Checklist Military Version (PCL-M)
Lasso di tempo: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Impact of Events Scale - Revised (IES-R)
Lasso di tempo: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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25-item Resilience Scale (RS)
Lasso di tempo: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
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Twenty-four-hour urinary samples
Lasso di tempo: pre-intervention and 3 months post intervention
|
pre-intervention and 3 months post intervention
|
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10-minute segment of a seated 30-minute electrocardiogram recording session
Lasso di tempo: pre-intervention and 3 months post intervention
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pre-intervention and 3 months post intervention
|
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Beck Depression Inventory (BDI)
Lasso di tempo: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
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Spielberger State Trait Anxiety Inventory (STAI)
Lasso di tempo: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Daily Sleep Wake Diaries
Lasso di tempo: during intervention (weeks 1-10) and 3 months post intervention
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during intervention (weeks 1-10) and 3 months post intervention
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Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Lasso di tempo: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Credibility Expectancy Questionnaire (CEQ)
Lasso di tempo: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Body-Oriented State Questionnaire (BOSC)
Lasso di tempo: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
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5-Facet Mindfulness Questionnaire (FFMQ)
Lasso di tempo: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Perceived Stress Scale (PSS)
Lasso di tempo: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Yoga Follow-up Questionnaire
Lasso di tempo: 3 months post intervention
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3 months post intervention
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PTSD Checklist Civilian Version (PCL-C)
Lasso di tempo: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Sat Bir S Khalsa, Ph.D., Brigham and Women's Hospital
- Direttore dello studio: Jennifer Johnston, MA, LMHC, Northeastern University
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Hoge CW, Auchterlonie JL, Milliken CS. Mental health problems, use of mental health services, and attrition from military service after returning from deployment to Iraq or Afghanistan. JAMA. 2006 Mar 1;295(9):1023-32. doi: 10.1001/jama.295.9.1023.
- van der Kolk BA. Clinical implications of neuroscience research in PTSD. Ann N Y Acad Sci. 2006 Jul;1071:277-93. doi: 10.1196/annals.1364.022.
- van der Kolk BA, Roth S, Pelcovitz D, Sunday S, Spinazzola J. Disorders of extreme stress: The empirical foundation of a complex adaptation to trauma. J Trauma Stress. 2005 Oct;18(5):389-99. doi: 10.1002/jts.20047.
- Creamer M, Burgess P, McFarlane AC. Post-traumatic stress disorder: findings from the Australian National Survey of Mental Health and Well-being. Psychol Med. 2001 Oct;31(7):1237-47. doi: 10.1017/s0033291701004287.
- Seligman MEP. Learned Optimism, 2nd Edition ed. New York, NY: Pocket Books; 1998.
- Morse DR, Cohen L, Furst ML, Martin JS. A physiological evaluation of the yoga concept of respiratory control of autonomic nervous system activity. Int J Psychosom. 1984;31(1):3-19. No abstract available.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 agosto 2009
Completamento primario (Effettivo)
1 maggio 2012
Completamento dello studio (Effettivo)
1 maggio 2012
Date di iscrizione allo studio
Primo inviato
13 agosto 2009
Primo inviato che soddisfa i criteri di controllo qualità
18 agosto 2009
Primo Inserito (Stima)
20 agosto 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
20 marzo 2013
Ultimo aggiornamento inviato che soddisfa i criteri QC
19 marzo 2013
Ultimo verificato
1 marzo 2013
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2009-P-000717
- 08144033
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 .