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

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.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder; Depression
• Intervention / Treatment: Behavioral: mind-body-skills group

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46254
      • Eskenazi Health Primary Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: mind-body-skills intervention; mind-body-skills group intervention offered weekly for 10 weeks	Behavioral: mind-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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Health Questionnaire-9 (PHQ-9) score	self report (9 questions) to screen for the presence and severity of depression	from baseline to within one month after end of intervention
Change in Patient Health Questionnaire-9 (PHQ-9) score	self report (9 questions) to screen for the presence and severity of depression	from baseline to approximately 3 months after end of intervention
Change in Rumination Subscale of the Children's Response Style Questionnaire Score	self report (13 questions) of rumination symptoms	from baseline to within one month after end of intervention
Change in Rumination Subscale of the Children's Response Style Questionnaire Score	self report (13 questions) of rumination symptoms	from baseline to approximately 3 months after end of intervention
Change in Mindful Attention Awareness Scale-Adolescent (MAAS) score	self report (14 questions) designed to assess open or receptive awareness of and attention to what is taking place in the present	from baseline to within one month after end of intervention
Change in Mindful Attention Awareness Scale-Adolescent (MAAS) score	self report (14 questions) designed to assess open or receptive awareness of and attention to what is taking place in the present	from baseline to approximately 3 months after end of intervention
Change in Self-Efficacy Questionnaire for Depression in Adolescents (SEQ-DA) score	self report (12 items) designed to measure self-perceived ability to cope with depressive symptoms	from baseline to within one month after end of intervention
Change in Self-Efficacy Questionnaire for Depression in Adolescents (SEQ-DA) score	self report (12 items) designed to measure self-perceived ability to cope with depressive symptoms	from baseline to approximately 3 months after end of intervention
Change in Suicide Ideation Questionnaire (SIQ) score	self report (30 or 15 items depending on grade level) to assess frequency of suicidal ideation	from baseline to within one month after end of intervention
Change in Suicide Ideation Questionnaire (SIQ) score	self report (30 or 15 items depending on grade level) to assess frequency of suicidal ideation	from baseline to approximately 3 months after end of intervention
Acceptability Questionnaire	self report (15 items) intervention acceptability assessment of usefulness and helpfulness of the intervention	within one month after end of intervention
Acceptability Questionnaire	self report (15 items) intervention acceptability assessment of usefulness and helpfulness of the intervention	approximately 3 months after end of intervention
Acceptability Questionnaire - open-ended questions for qualitative analyses	3 open-ended questions to gather qualitative data about the usefulness and helpfulness of the intervention	within one month after end of intervention
Acceptability Questionnaire - open-ended questions for qualitative analyses	3 open-ended questions to gather qualitative data about the usefulness and helpfulness of the intervention	approximately 3 months after end of intervention
Change in Hope Scale Score	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	from baseline to within one month after end of intervention
Change in Hope Scale Score	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	from baseline to approximately 3 months after end of intervention
Change in Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) Score	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	from baseline to within one month after end of intervention
Change in Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) Score	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	from baseline to approximately 3 months after end of intervention

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Eskenazi Health; The Center for Mind-Body Medicine
• Investigators: Principal Investigator: Michelle P Salyers, PhD, Indiana University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2018
• Primary Completion (ACTUAL): September 4, 2019
• Study Completion (ACTUAL): September 4, 2019

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (ACTUAL): December 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Adolescent; Depression; primary care; group therapy; mind-body-skills
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 1707293729

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No