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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03363750
Enrollment
49
Registered
2017-12-06
Start date
2018-01-25
Completion date
2019-09-04
Last updated
2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Depressive Disorder

Keywords

Depression, Adolescent, mind-body-skills, group therapy, primary care

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.

Interventions

BEHAVIORALmind-body-skills group

mind-body skills group program incorporates meditation, guided imagery, breathing techniques, autogenic training, biofeedback, genograms, and self-expression through words, drawings, and movement

Sponsors

The Center for Mind-Body Medicine
CollaboratorOTHER
Eskenazi Health
CollaboratorOTHER
Indiana University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Children's Depression Inventory-2 (CDI-2) scoresfrom baseline to within one month after end of interventionself report long version (28 items) to assess the presence and severity of depressive symptoms in children

Secondary

MeasureTime frameDescription
Change in Rumination Subscale of the Children's Response Style Questionnaire Scorefrom baseline to within one month after end of interventionself report (13 questions) of rumination symptoms
Change in Mindful Attention Awareness Scale-Adolescent (MAAS) scorefrom baseline to within one month after end of interventionself report (14 questions) designed to assess open or receptive awareness of and attention to what is taking place in the present
Change in Self-Efficacy Questionnaire for Depression in Adolescents (SEQ-DA) scorefrom baseline to within one month after end of interventionself report (12 items) designed to measure self-perceived ability to cope with depressive symptoms
Change in Suicide Ideation Questionnaire (SIQ) scorefrom baseline to within one month after end of interventionself report (30 or 15 items depending on grade level) to assess frequency of suicidal ideation
Change in Patient Health Questionnaire-9 (PHQ-9) scorefrom baseline to within one month after end of interventionself report (9 questions) to screen for the presence and severity of depression
Acceptability Questionnaire - open-ended questions for qualitative analyseswithin one month after end of intervention3 open-ended questions to gather qualitative data about the usefulness and helpfulness of the intervention
Change in Hope Scale Scorefrom baseline to within one month after end of intervention* self report (12 items), 4-point Likert scale(1=Definitely False to 4=Definitely True) * evaluates global hope (range 8-32); there are also 2 subscales: hope agency (range 4-16) and hope pathways (range 4-16) * includes distracter items * global hope score calculated by summing the hope agency and hope pathways scores (omitting distracter items) * higher scores indicate a person has higher hope
Change in Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) Scorefrom baseline to within one month after end of intervention* self report (14 items) to measure positive affect, satisfying interpersonal relationships, and positive functioning * 5-point Likert scale (1=none of the time to 5=all of the time) * total score is calculated by summing each item score (range 14-70) * higher scores represent increased levels of mental wellbeing
Acceptability Questionnairewithin one month after end of interventionself report (15 items) intervention acceptability assessment of usefulness and helpfulness of the intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026