Clinical trial NCT02373358: Evaluation of Effectiveness of a Group Yoga Intervention as Trauma Therapy for Adolescent Girls
Official title: A Mixed Methods Evaluation of Effectiveness of a Group Yoga Intervention as an Adjunctive Trauma Therapy for Adolescent Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: Complex trauma
Yoga
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 34
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: A mixed methods design was chosen for this study due to the study representing a new stream of literature, and a desire to capture the fullest picture possible regarding the participants' response to the intervention. The purpose of this mixed methods study is to generate quantitative data that demonstrates a decrease in trauma and general mental health symptoms following a yoga psychotherapy intervention for trauma, and to collect qualitative data during the group process and following the group that provides a picture of the mechanisms that allow the intervention to be effective. Broad Hypotheses: Quantitatively, there will be significant differences in total number of mental health symptoms and trauma-related symptoms experienced from pretest to posttest. Qualitative data will demonstrate the benefits from the yoga postures and experiences of relaxing breath work the youth experienced during the yoga group.

Trauma is a prevalent experience in our society, with between 50-76% of individuals experiencing a traumatic event with the potential to cause Posttraumatic Stress Disorder. The current standard of care in trauma treatment largely involves cognitive interventions, but neuroscience evidence demonstrates reasons for their limited effectiveness and a need to help traumatized individuals regulate the brain from the lowest levels up. Neuroscience research indicates the brains of individuals who have experienced trauma are less able to use cognitive centers to suppress emotional fear responses, and language centers in the brain experience deactivation during traumatic events. Indeed, 33% of individuals who develop PTSD fail to recover fully, which leads to ongoing mental health difficulties, impaired interpersonal relationships, substance abuse, physical health problems, and sexual problems.

Yoga has been proposed as a somatic, bottom-up intervention that allows the individual to regulate from the lowest level of the brain to higher levels of the brain by working with the body and mindful experience in the present moment. Existing investigation of yoga as a psychotherapeutic intervention is preliminary, but promising. van der Kolk and colleagues conducted a preliminary randomized controlled study and found that over 50% of individuals who participated in the yoga group no longer met criteria for Posttraumatic Stress Disorder following the group. Carmody and Baer found that yoga-based interventions in Mindfulness-Based Stress Reduction impacted the widest range of symptoms (compared to body scans and seated meditation). No quantitative investigations of trauma-related yoga treatment for adolescents have been conducted, other than one dissertation with juvenile sex offenders. Existing yoga psychotherapy research on youth who have experienced trauma has been qualitative in nature with case studies and limited samples.

Additional study of yoga as an intervention for traumatized adolescents is needed both quantitatively and qualitatively. One model of group yoga as adjunctive treatment for trauma has been identified in the literature, but it has only been described anecdotally and with limited qualitative data. Thus, the aim of the current study is to use the model created for the Healing Childhood Sexual Abuse with Yoga curriculum with a wider sample of adolescents across types of trauma (emotional, physical, \& sexual abuse \& neglect) in the United States and Canada to generalize the curriculum and generate qualitative and quantitative data regarding its effectiveness and the perceived mechanisms that contribute to success. Additional qualitative research would be beneficial to describe the themes and cases across a full sample of participants in such a group. Current research has been observational, case studies, or limited qualitative questionnaires at the end of the group, but this study proposes to collect qualitative data at each group yoga session regarding the experience. In addition, follow-up interviews are also proposed to ask more detailed questions about the participants' experiences.

Participants will be referred from within the agencies providing the groups, and therapists will complete an internal referral form providing minimal demographic data with the referral. Participants will be contacted by the respective group leaders at the phone numbers listed on the referrals forms. Prior to the beginning of the initial group, the group leaders will meet with prospective clients to interview them for appropriateness for the group, obtain informed consent and assent, and allow them to complete the pretest measures. In addition to obtaining informed consent for the research process, the group leader will explain the physical nature of the yoga group, and the group leader will obtain waivers from parents for the youth to participate in the physical activity involved in the group. Copies of consent and assent forms will be provided to participants and parents.

During each group, participants will complete the Yoga Experience Form at each session. Posttests will be completed at the end of the sixth group meeting. They will include all the pretest questionnaires, as well as the Therapeutic Factors Inventory- Cohesiveness Scale and the Working Alliance Inventory-Short Form- Bond Scale. After the final group, pretest, within, and posttest data will be coded and analyzed to determine the questions to be utilized for the follow-up interviews. Two participants from each group at McMaster Children's Hospital will be asked to complete a follow-up interview with the investigator that will be approximately 30 minutes in length. Participants will be selected with well defined symptom improvement and poor response to the intervention. The follow-up interviews will be audio recorded. Willingness to be audio recorded is necessary for participation in the follow-up interviews, but not for participation in the larger group. The time commitment for the treatment group is 540 minutes. This study does not involve additional post-treatment follow-up, aside from clients who volunteer to participate in the follow-up interviews.

Eligibility 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)

Primary outcomes:
measure: Change from baseline in general mental health symptoms at 6 weeks
timeFrame: Entry & at 6 weeks
measure: Change from baseline in PTSD symptoms
timeFrame: Entry & at 6 weeks
Secondary outcomes:
measure: Change from baseline in trauma-related beliefs
timeFrame: Entry & and at 6 weeks
measure: Therapeutic Factors Inventory- Cohesiveness Scale
timeFrame: After 6 weeks of intervention
measure: Working Alliance Inventory- Short Form- Bond Scale
timeFrame: After 6 weeks of intervention
measure: Interviews to assess benefits and limitations of the group yoga intervention following group
timeFrame: After 6 weeks of intervention
measure: Weekly Yoga Experiences Form
timeFrame: Weekly for 6 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Children's Advocacy Center
state: Colorado
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: University of Denver
name: Cynthia McRae, PhD
role: STUDY_CHAIR
affiliation: Hamilton Health Sciences Corporation
name: Paulo Pires, PhD
role: STUDY_DIRECTOR
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