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Evaluation of Effectiveness of a Group Yoga Intervention as Trauma Therapy for Adolescent Girls

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ClinicalTrials.gov Identifier: NCT02373358
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
Hamilton Health Sciences Corporation

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.

Condition or disease Intervention/treatment Phase
PTSD Behavioral: Group yoga intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Mixed Methods Evaluation of Effectiveness of a Group Yoga Intervention as an Adjunctive Trauma Therapy for Adolescent Girls
Study Start Date : May 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group yoga intervention
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
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.




Primary Outcome Measures :
  1. Change from baseline in general mental health symptoms at 6 weeks [ Time Frame: Entry & 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).

  2. Change from baseline in PTSD symptoms [ Time Frame: Entry & at 6 weeks ]
    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.


Secondary Outcome Measures :
  1. Change from baseline in trauma-related beliefs [ Time Frame: Entry & and at 6 weeks ]
    The author developed an affirmation questionnaire corresponding to the affirmations/mantras used in each group. For example, affirmations included "I believe that I have the right to be safe," "I can tell others 'no' when they intrude in my personal space," and "I feel that I am strong." In addition, two general questions were included that asked about the client's ability to regulate her emotions and having skills that help her cope with her trauma. Responses are scored on a 5-point Likert scale with scores ranging from 1= strongly disagree to 5= strongly agree. Total scores for this questionnaire range from 10 to 50.

  2. Therapeutic Factors Inventory- Cohesiveness Scale [ Time Frame: After 6 weeks of intervention ]
    This measure was chosen to address potential effects of group cohesion that contributed to the study outcomes to control for this effect, and will be given after the group intervention. The nine-item Cohesiveness scale measures socio-emotional aspects of group cohesion (MacNair-Semands & Lese, 2000), drawing on Yalom's (1995) therapeutic factors. Responses are rated on a 7-point Likert-like scale from strongly disagree=1 to strongly agree=7. Items include "I feel accepted by the group," "I feel a sense of belonging in the group," and "We trust each other in my group." Previous test-retest reliability of 0.93 was reported, as well as a previous a level of 0.90 (MacNair-Semands & Lese, 2000).

  3. Working Alliance Inventory- Short Form- Bond Scale [ Time Frame: After 6 weeks of intervention ]
    The Working Alliance Inventory - Short Form (WAI-S) (Tracey & Kokotovic, 1989) is a 12-item 5-point Likert measure derived from the original 36-item version (Horvath & Greenberg, 1989) that assesses the three dimensions of agreement on pertinent therapeutic tasks (Tasks), agreement on therapeutic goals (Goals), and development of affective bonds between client and therapist (Bond). Tracey and Kokotovic (1989) reported evidence supporting the construct validity of the WAI - Short Form, as well as high internal consistency estimates from .83 to .98 for its three factors. This study is using the 4-item bonds scale in order to control for the effects of the therapeutic alliance on the group. Items include "I believe ___ likes me," and "I feel that ____ appreciates me."

  4. Interviews to assess benefits and limitations of the group yoga intervention following group [ Time Frame: After 6 weeks of intervention ]
    Follow-up qualitative interviews will be conducted with a subset of group participants. An even number of participants will be selected from each group, and attempts will be made to balance the number of participants with PTSD diagnoses and with subclinical symptoms and those who benefited from the group and did not. Questions include: 1. In what ways do you think yoga contributed to the experience of this group? 2. In what ways do you think being in a group affected this experience? 3. Would you do this group again if offered? Why or why not? 4. What were some important things/the most important thing you learned about yourself from these sessions? 5. What wasn't helpful for you about these sessions? 6. Were any of the themes easier or more difficult to relate to than others?

  5. Weekly Yoga Experiences Form [ Time Frame: Weekly for 6 weeks ]
    During each session, clients will fill out a Yoga Experiences Form rating their levels of calmness versus distress on a scale of 1 to 10 prior to the group and then following the group, as well as commenting on content of the group that they found helpful and difficult, that came into their awareness, and that they want to practice again.



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373358


Locations
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United States, Colorado
Denver Children's Advocacy Center
Denver, Colorado, United States, 80210
Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L9C 1C4
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
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Study Chair: Cynthia McRae, PhD University of Denver
Study Director: Paulo Pires, PhD Hamilton Health Sciences Corporation
Publications:
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.
Emerson, D., Sharma, R., Chaudhry, S. & Turner, J. (2009). Trauma-sensitive yoga: Principles, practice, and research. International Journal of Yoga Therapy, 19, 123-128.
Horvath, A. O., Greenberg, L. S. (1989). Development and validation of the Working Alliance Inventory. Journal of Counseling Psychology, 36(2), 223-233.
Lilly, M., & Hedlund, J. (2010). Yoga therapy in practice: Healing childhood sexual abuse with yoga. International Journal of Yoga Therapy, 20, 120-130.
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.
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.
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.
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.
Tracey, T. J., & Kokotovic, A. M. (1989). Factor structure of the Working Alliance Inventory. Psychological Assessment, 1, 207- 210.
van der Kolk, B. A. (2005). Developmental trauma disorder. Psychiatric Annals, 35(5), 401-408.
Wells, M. G., Burlingame, G. M., & Lambert, P. M. (2003). Y-OQ-SR2.0: Administration & Scoring Manual. Salt Lake City, UT: OQ Measures, LLC.
Yalom, I. D. (1995). The Theory and Practice of Group Psychotherapy. New York: Basic Books.

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Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT02373358    
Other Study ID Numbers: 700871-1
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015
Keywords provided by Hamilton Health Sciences Corporation:
Complex trauma
Yoga
Additional relevant MeSH terms:
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Wounds and Injuries