Study of Mind-Body Skills Groups for Adolescents With Depression in Primary Care
Pilot Study of Mind-Body Skills Groups for Adolescents With Depression in Primary Care
1 other identifier
interventional
49
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable depression
Started Jan 2018
1 active site
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
November 21, 2017
CompletedFirst Posted
Study publicly available on registry
December 6, 2017
CompletedStudy Start
First participant enrolled
January 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2019
CompletedMarch 10, 2020
March 1, 2020
1.6 years
November 21, 2017
March 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Children's Depression Inventory-2 (CDI-2) scores
self report long version (28 items) to assess the presence and severity of depressive symptoms in children
from baseline to within one month after end of intervention
Change in Children's Depression Inventory-2 (CDI-2) scores
self report long version (28 items) to assess the presence and severity of depressive symptoms in children
from baseline to approximately 3 months after end of intervention
Secondary Outcomes (18)
Change in Patient Health Questionnaire-9 (PHQ-9) score
from baseline to within one month after end of intervention
Change in Patient Health Questionnaire-9 (PHQ-9) score
from baseline to approximately 3 months after end of intervention
Change in Rumination Subscale of the Children's Response Style Questionnaire Score
from baseline to within one month 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 within one month after end of intervention
- +13 more secondary outcomes
Study Arms (1)
mind-body-skills intervention
EXPERIMENTALmind-body-skills group intervention offered weekly for 10 weeks
Interventions
mind-body skills group program incorporates meditation, guided imagery, breathing techniques, autogenic training, biofeedback, genograms, and self-expression through words, drawings, and movement
Eligibility Criteria
You may qualify if:
- Eskenazi Primary Care patients at time of screening
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- The Center for Mind-Body Medicinecollaborator
- Eskenazi Healthcollaborator
Study Sites (1)
Eskenazi Health Primary Care
Indianapolis, Indiana, 46254, United States
Related Publications (1)
Cunningham LD, Salgado EF, Aalsma MC, Garabrant JM, Staples JK, Gordon JS, Salyers MP. Do adolescents consider mind-body skills groups an acceptable treatment for depression: results from a pilot study. BMC Pediatr. 2021 Oct 27;21(1):475. doi: 10.1186/s12887-021-02942-3.
PMID: 34706710DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle P Salyers, PhD
Indiana University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 21, 2017
First Posted
December 6, 2017
Study Start
January 25, 2018
Primary Completion
September 4, 2019
Study Completion
September 4, 2019
Last Updated
March 10, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share