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

Not Applicable

Completed

• Conditions: Depression; Depressive Disorder
• Interventions: Behavioral: mind-body-skills group

• Registration Number: NCT03363750
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-06
• Study Start: 2018-01-25
• Primary Completion: 2019-09-04
• Study Completion: 2019-09-04
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mind-body-skills intervention	mind-body-skills group	mind-body-skills group intervention offered weekly for 10 weeks

Primary Outcome Measures

Name	Time	Method
Change in Children's Depression Inventory-2 (CDI-2) scores	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 Outcome Measures

Name	Time	Method
Change in Hope Scale Score	from baseline to approximately 3 months 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 Patient Health Questionnaire-9 (PHQ-9) score	from baseline to approximately 3 months after end of intervention	self report (9 questions) to screen for the presence and severity of depression
Acceptability Questionnaire	approximately 3 months after end of intervention	self report (15 items) intervention acceptability assessment of usefulness and helpfulness of the intervention
Change in Rumination Subscale of the Children's Response Style Questionnaire Score	from baseline to approximately 3 months after end of intervention	self report (13 questions) of rumination symptoms
Change in Mindful Attention Awareness Scale-Adolescent (MAAS) score	from baseline to approximately 3 months after end of intervention	self 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) score	from baseline to approximately 3 months after end of intervention	self report (12 items) designed to measure self-perceived ability to cope with depressive symptoms
Change in Suicide Ideation Questionnaire (SIQ) score	from baseline to approximately 3 months after end of intervention	self report (30 or 15 items depending on grade level) to assess frequency of suicidal ideation
Acceptability Questionnaire - open-ended questions for qualitative analyses	approximately 3 months after end of intervention	3 open-ended questions to gather qualitative data about the usefulness and helpfulness of the intervention
Change in Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) Score	from baseline to approximately 3 months after end of intervention	* self report (14 items) to measure positive affect, satisfying interpersonal relationships, and positive functioning (range 14-70); * 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

Trial Locations

Locations (1)

Eskenazi Health Primary Care; 🇺🇸 Indianapolis, Indiana, United States