NCT02373358

Brief Summary

Neuroscience evidence indicates that trauma is stored in the body, that trauma impairs the language centers found in the brain, and that emotion centers in the brain tend to override cognitive centers in the brain following trauma. Most evidence-based models to date to treat trauma using cognitive therapy, which does not fully resolve symptoms, particularly in the case of complex trauma. This evidence has led to researchers to call for alternative, body-oriented treatments that target trauma from the lowest levels of regulation up to higher levels of regulation in the brain. Yoga has been proposed as one such intervention. Recent research has investigated the benefits of yoga to treatment adult females who have experienced PTSD, but only anecdotal, descriptive, and qualitative data is available for studies of yoga with adolescents. This mixed methods study seeks to generate quantitative data demonstrating whether or not the 6-week group yoga intervention leads to decreases in general mental health and trauma-specific symptoms and qualitative data regarding the components of the intervention the participants found both helpful and unhelpful.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

4 months

First QC Date

February 9, 2015

Last Update Submit

October 13, 2015

Conditions

Keywords

Complex traumaYoga

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in general mental health symptoms at 6 weeks

    The Youth Outcomes Questionnaire-Self Report (YOQ-SR) is used to evaluate treatment outcomes based on global symptom reduction (Wells, Burlingame, \& Lambert, 2003). The YOQ is very sensitive to change, and individuals are asked to report on their symptoms within the last seven days. The 64-item questionnaire produces a total score of -16 to 240 (due to negative scores being awarded for reverse-scored items, a negative score is possible). Symptoms are rated on a 5-point Likert scale from Never or Almost Never to Almost Always or Always. Questions include, "I want to be alone more than others my same age," "My emotions are strong and change quickly," "I am calm," and "I don't forgive myself for things I've done wrong." The YOQ-SR was chosen due to its ease of use, brief administration time, sensitivity to change, and previous data supporting strong reliability and validity (Wells, Burlingame, \& Lambert, 2003).

    Entry & at 6 weeks

  • Change from baseline in PTSD symptoms

    The Child PTSD Symptom Scale (CPSS) assesses PTSD symptom severity in children 8-18 based on Diagnostic and Statistical Manual or Mental Disorders, 4th edition diagnostic criteria (Foa, Johnson, Feeny, \& Treadwell, 2001). It includes 17 items that map onto diagnostic criteria, \& 7 items assessing functional impairment caused by the PTSD symptoms. It can be completed in 10 minutes. Part one of the questionnaire involves a 4-point Likert-like scale (from 0=not at all or only at one time to 3=5 or more times a week/almost always), and part two involves dichotomous questions. The measure yields a total score from 0 to 51 with a clinical cutoff of 15, and also provides three subscale scores for re-experiencing, avoidance, and hyperarousal. The measure is relatively time-sensitive, asking respondents to indicate how many times a problem has bothered her in the last two weeks.

    Entry & at 6 weeks

Secondary Outcomes (5)

  • Change from baseline in trauma-related beliefs

    Entry & and at 6 weeks

  • Therapeutic Factors Inventory- Cohesiveness Scale

    After 6 weeks of intervention

  • Working Alliance Inventory- Short Form- Bond Scale

    After 6 weeks of intervention

  • Interviews to assess benefits and limitations of the group yoga intervention following group

    After 6 weeks of intervention

  • Weekly Yoga Experiences Form

    Weekly for 6 weeks

Study Arms (1)

Group yoga intervention

EXPERIMENTAL

Participants will participate in 6 90-minute yoga groups designed to promote themes related to trauma recovery (safety \& boundaries, strength \& power, assertiveness, intuition, trust, \& community) using mindfulness, breath work, and physical yoga poses.

Behavioral: Group yoga intervention

Interventions

Participants will participate in 6 90-minute yoga groups designed to promote themes related to trauma recovery (safety \& boundaries, strength \& power, assertiveness, intuition, trust, \& community) using mindfulness, breath work, and physical yoga poses.

Group yoga intervention

Eligibility Criteria

Age11 Years - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents between the ages of 11 and 18
  • Current participation in outpatient treatment at the Denver Children's Advocacy Center or McMaster Children's Hospital (Regional and Outpatient Services).
  • History of complex trauma with clinical or subclinical PTSD symptoms

You may not qualify if:

  • Non-English-speaking individuals.
  • Currently suicidal, homicidal, or psychotic
  • Significant substance use (daily or greater use of marijuana or weekly or greater use of other non-prescription/illegal drugs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Denver Children's Advocacy Center

Denver, Colorado, 80210, United States

Location

Hamilton Health Sciences

Hamilton, Ontario, L9C 1C4, Canada

Location

Related Publications (25)

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    PMID: 17899351BACKGROUND
  • Copeland WE, Keeler G, Angold A, Costello EJ. Traumatic events and posttraumatic stress in childhood. Arch Gen Psychiatry. 2007 May;64(5):577-84. doi: 10.1001/archpsyc.64.5.577.

    PMID: 17485609BACKGROUND
  • Dale, L. P., Carroll, L. E., Galen, G. C., Schein, R., Bliss, A., Mattison, A. M., & Neace, W. P. (2011). Yoga practice may buffer the deleterious effects of abuse on women's self-concept and dysfunctional coping. Journal of Aggression, Maltreatment, & Trauma, 20, 89-101.

    BACKGROUND
  • D'Andrea W, Ford J, Stolbach B, Spinazzola J, van der Kolk BA. Understanding interpersonal trauma in children: why we need a developmentally appropriate trauma diagnosis. Am J Orthopsychiatry. 2012 Apr;82(2):187-200. doi: 10.1111/j.1939-0025.2012.01154.x.

    PMID: 22506521BACKGROUND
  • Dick AM, Niles BL, Street AE, DiMartino DM, Mitchell KS. Examining mechanisms of change in a yoga intervention for women: the influence of mindfulness, psychological flexibility, and emotion regulation on PTSD symptoms. J Clin Psychol. 2014 Dec;70(12):1170-82. doi: 10.1002/jclp.22104. Epub 2014 May 28.

    PMID: 24888209BACKGROUND
  • Emerson, D., Sharma, R., Chaudhry, S. & Turner, J. (2009). Trauma-sensitive yoga: Principles, practice, and research. International Journal of Yoga Therapy, 19, 123-128.

    BACKGROUND
  • Foa EB, Johnson KM, Feeny NC, Treadwell KR. The child PTSD Symptom Scale: a preliminary examination of its psychometric properties. J Clin Child Psychol. 2001 Sep;30(3):376-84. doi: 10.1207/S15374424JCCP3003_9.

    PMID: 11501254BACKGROUND
  • Koenigs M, Grafman J. Posttraumatic stress disorder: the role of medial prefrontal cortex and amygdala. Neuroscientist. 2009 Oct;15(5):540-8. doi: 10.1177/1073858409333072. Epub 2009 Apr 9.

    PMID: 19359671BACKGROUND
  • Horvath, A. O., Greenberg, L. S. (1989). Development and validation of the Working Alliance Inventory. Journal of Counseling Psychology, 36(2), 223-233.

    BACKGROUND
  • Lilly, M., & Hedlund, J. (2010). Yoga therapy in practice: Healing childhood sexual abuse with yoga. International Journal of Yoga Therapy, 20, 120-130.

    BACKGROUND
  • MacNair-Semands, R. R., & Lese, K. P. (2000). Interpersonal problems and the perception of therapeutic factors in group therapy. Small Group Research, 31(2), 158-174.

    BACKGROUND
  • McLaughlin KA, Koenen KC, Hill ED, Petukhova M, Sampson NA, Zaslavsky AM, Kessler RC. Trauma exposure and posttraumatic stress disorder in a national sample of adolescents. J Am Acad Child Adolesc Psychiatry. 2013 Aug;52(8):815-830.e14. doi: 10.1016/j.jaac.2013.05.011. Epub 2013 Jun 25.

    PMID: 23880492BACKGROUND
  • McRae, K., Ochsner, K. N., & Gross, J. J. (2011). The reason in passion: A social cognitive neuroscience approach to emotion regulation (Chapter 10). In Handbook of Self-Regulation, Second Edition: Research, Theory, and Applications. New York: The Guilford Press.

    BACKGROUND
  • Michalsen A, Jeitler M, Brunnhuber S, Ludtke R, Bussing A, Musial F, Dobos G, Kessler C. Iyengar yoga for distressed women: a 3-armed randomized controlled trial. Evid Based Complement Alternat Med. 2012;2012:408727. doi: 10.1155/2012/408727. Epub 2012 Sep 25.

    PMID: 23049608BACKGROUND
  • Mitchell KS, Dick AM, DiMartino DM, Smith BN, Niles B, Koenen KC, Street A. A pilot study of a randomized controlled trial of yoga as an intervention for PTSD symptoms in women. J Trauma Stress. 2014 Apr;27(2):121-8. doi: 10.1002/jts.21903. Epub 2014 Mar 25.

    PMID: 24668767BACKGROUND
  • Neumann, D. A., Houskamp, B. M., Pollock, V. E., & Briere, J. (1996). The long-term sequelae of childhood sexual abuse in women: A meta-analytic review. Child Maltreatment, 1(1), 6-16.

    BACKGROUND
  • Pelcovitz D, Kaplan S, Goldenberg B, Mandel F, Lehane J, Guarrera J. Post-traumatic stress disorder in physically abused adolescents. J Am Acad Child Adolesc Psychiatry. 1994 Mar-Apr;33(3):305-12. doi: 10.1097/00004583-199403000-00002.

    PMID: 8169174BACKGROUND
  • Perry, B. D. (2009). Examining child maltreatment through a neurodevelopmental lens: Clinical applications of the Neurosequential Model of Therapeutics. Journal of Loss & Trauma, 14, 240-255.

    BACKGROUND
  • Tracey, T. J., & Kokotovic, A. M. (1989). Factor structure of the Working Alliance Inventory. Psychological Assessment, 1, 207- 210.

    BACKGROUND
  • Van Ameringen M, Mancini C, Patterson B, Boyle MH. Post-traumatic stress disorder in Canada. CNS Neurosci Ther. 2008 Fall;14(3):171-81. doi: 10.1111/j.1755-5949.2008.00049.x.

    PMID: 18801110BACKGROUND
  • van der Kolk, B. A. (2005). Developmental trauma disorder. Psychiatric Annals, 35(5), 401-408.

    BACKGROUND
  • 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.

    PMID: 16891578BACKGROUND
  • van der Kolk BA, Stone L, West J, Rhodes A, Emerson D, Suvak M, Spinazzola J. Yoga as an adjunctive treatment for posttraumatic stress disorder: a randomized controlled trial. J Clin Psychiatry. 2014 Jun;75(6):e559-65. doi: 10.4088/JCP.13m08561.

    PMID: 25004196BACKGROUND
  • Wells, M. G., Burlingame, G. M., & Lambert, P. M. (2003). Y-OQ-SR2.0: Administration & Scoring Manual. Salt Lake City, UT: OQ Measures, LLC.

    BACKGROUND
  • Yalom, I. D. (1995). The Theory and Practice of Group Psychotherapy. New York: Basic Books.

    BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Cynthia McRae, PhD

    University of Denver

    STUDY CHAIR
  • Paulo Pires, PhD

    Hamilton Health Sciences Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 27, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations