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Clinical Trials/NCT03363750
NCT03363750
Completed
Not Applicable

Pilot Study of Mind-Body Skills Groups for Adolescents With Depression in Primary Care

Indiana University1 site in 1 country49 target enrollmentJanuary 25, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Indiana University
Enrollment
49
Locations
1
Primary Endpoint
Change in Children's Depression Inventory-2 (CDI-2) scores
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The Center for Mind -Body Medicine has developed a mind-body skills group program that incorporates meditation, guided imagery, breathing techniques, autogenic training, biofeedback, genograms, and self-expression through words, drawings, and movement. These mind-body skills are designed to increase self-awareness and self-regulation. This program has been shown to significantly improve depression symptoms in children and adolescents with posttraumatic stress disorder in Gaza, but it has not yet been tested in a US adolescent population. The purpose of this study is to determine the feasibility of using mind-body skills groups to reduce depression in adolescents and to investigate the effects of the program on factors such as self-efficacy, mindfulness and rumination which are likely to mediate improvement.

Registry
clinicaltrials.gov
Start Date
January 25, 2018
End Date
September 4, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michelle Salyers

Professor

Indiana University

Eligibility Criteria

Inclusion Criteria

  • Eskenazi Primary Care patients at time of screening
  • 13-17 years old
  • Diagnosis of depression confirmed by Mini International Neuropsychiatric Interview (MINI) Kid Screen (with adolescent)
  • English speaking
  • Willingness to attend mind body skills group for duration of the intervention (10 sessions over approximately 10 weeks)

Exclusion Criteria

  • History of bipolar disorder or psychosis
  • Acute and immediate risk of suicide, determined by clinical assessment
  • Lack of capacity to assent (adolescent) or lack of capacity to consent (parent/guardian)
  • Previous participation by the adolescent in the Eskenazi Mind Body Group intervention

Outcomes

Primary Outcomes

Change in Children's Depression Inventory-2 (CDI-2) scores

Time Frame: from baseline to approximately 3 months after end of intervention

self report long version (28 items) to assess the presence and severity of depressive symptoms in children

Secondary Outcomes

  • Change in Patient Health Questionnaire-9 (PHQ-9) score(from baseline to approximately 3 months after end of intervention)
  • Change in Hope Scale Score(from baseline to approximately 3 months after end of intervention)
  • Acceptability Questionnaire(approximately 3 months after end of intervention)
  • Change in Rumination Subscale of the Children's Response Style Questionnaire Score(from baseline to approximately 3 months after end of intervention)
  • Change in Mindful Attention Awareness Scale-Adolescent (MAAS) score(from baseline to approximately 3 months after end of intervention)
  • Change in Self-Efficacy Questionnaire for Depression in Adolescents (SEQ-DA) score(from baseline to approximately 3 months after end of intervention)
  • Change in Suicide Ideation Questionnaire (SIQ) score(from baseline to approximately 3 months after end of intervention)
  • Acceptability Questionnaire - open-ended questions for qualitative analyses(approximately 3 months after end of intervention)
  • Change in Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) Score(from baseline to approximately 3 months after end of intervention)

Study Sites (1)

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