Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder (EYIPTSD)
19. März 2013 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
108
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Massachusetts
-
Boston, Massachusetts, Vereinigte Staaten, 02215
- Brigham and Women's Hospital
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Yoga-Behandlung
|
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.
Andere Namen:
|
|
Kein Eingriff: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Clinician Administered PTSD Scale (CAPS)
Zeitfenster: pre-intervention and 10 weeks
|
pre-intervention and 10 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
PTSD Checklist Military Version (PCL-M)
Zeitfenster: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
|
Impact of Events Scale - Revised (IES-R)
Zeitfenster: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
|
25-item Resilience Scale (RS)
Zeitfenster: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
|
Twenty-four-hour urinary samples
Zeitfenster: pre-intervention and 3 months post intervention
|
pre-intervention and 3 months post intervention
|
|
10-minute segment of a seated 30-minute electrocardiogram recording session
Zeitfenster: pre-intervention and 3 months post intervention
|
pre-intervention and 3 months post intervention
|
|
Beck Depression Inventory (BDI)
Zeitfenster: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
|
Spielberger State Trait Anxiety Inventory (STAI)
Zeitfenster: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
|
Daily Sleep Wake Diaries
Zeitfenster: during intervention (weeks 1-10) and 3 months post intervention
|
during intervention (weeks 1-10) and 3 months post intervention
|
|
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Zeitfenster: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
|
Credibility Expectancy Questionnaire (CEQ)
Zeitfenster: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
|
Body-Oriented State Questionnaire (BOSC)
Zeitfenster: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
|
5-Facet Mindfulness Questionnaire (FFMQ)
Zeitfenster: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
|
Perceived Stress Scale (PSS)
Zeitfenster: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
|
Yoga Follow-up Questionnaire
Zeitfenster: 3 months post intervention
|
3 months post intervention
|
|
PTSD Checklist Civilian Version (PCL-C)
Zeitfenster: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Sat Bir S Khalsa, Ph.D., Brigham and Women's Hospital
- Studienleiter: Jennifer Johnston, MA, LMHC, Northeastern University
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. August 2009
Primärer Abschluss (Tatsächlich)
1. Mai 2012
Studienabschluss (Tatsächlich)
1. Mai 2012
Studienanmeldedaten
Zuerst eingereicht
13. August 2009
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
18. August 2009
Zuerst gepostet (Schätzen)
20. August 2009
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
20. März 2013
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
19. März 2013
Zuletzt verifiziert
1. März 2013
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2009-P-000717
- 08144033
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .