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

Study Overview
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Brief Summary
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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.

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

Conditions
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Depression, Depressive Disorder

Intervention / Treatment
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* Behavioral: mind-body-skills group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mind-body-skills intervention<br>mind-body-skills group intervention offered weekly for 10 weeks | Behavioral: mind-body-skills group<br>* mind-body skills group program incorporates meditation, guided imagery, breathing techniques, autogenic training, biofeedback, genograms, and self-expression through words, drawings, and movement<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Adolescent, mind-body-skills, group therapy, primary care