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

Primary Purpose

Depression, Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mind-body-skills group
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depression focused on measuring Depression, Adolescent, mind-body-skills, group therapy, primary care

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eskenazi Health Primary Care

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mind-body-skills intervention

Arm Description

mind-body-skills group intervention offered weekly for 10 weeks

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Change in Patient Health Questionnaire-9 (PHQ-9) score
self report (9 questions) to screen for the presence and severity of depression
Change in Patient Health Questionnaire-9 (PHQ-9) score
self report (9 questions) to screen for the presence and severity of depression
Change in Rumination Subscale of the Children's Response Style Questionnaire Score
self report (13 questions) of rumination symptoms
Change in Rumination Subscale of the Children's Response Style Questionnaire Score
self report (13 questions) of rumination symptoms
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
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
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
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
Change in Suicide Ideation Questionnaire (SIQ) score
self report (30 or 15 items depending on grade level) to assess frequency of suicidal ideation
Change in Suicide Ideation Questionnaire (SIQ) score
self report (30 or 15 items depending on grade level) to assess frequency of suicidal ideation
Acceptability Questionnaire
self report (15 items) intervention acceptability assessment of usefulness and helpfulness of the intervention
Acceptability Questionnaire
self report (15 items) intervention acceptability assessment of usefulness and helpfulness of the 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
Acceptability Questionnaire - open-ended questions for qualitative analyses
3 open-ended questions to gather qualitative data about the usefulness and helpfulness of the 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
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
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
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

Full Information

First Posted
November 21, 2017
Last Updated
March 9, 2020
Sponsor
Indiana University
Collaborators
The Center for Mind-Body Medicine, Eskenazi Health
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1. Study Identification

Unique Protocol Identification Number
NCT03363750
Brief Title
Study of Mind-Body Skills Groups for Adolescents With Depression in Primary Care
Official Title
Pilot Study of Mind-Body Skills Groups for Adolescents With Depression in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 25, 2018 (Actual)
Primary Completion Date
September 4, 2019 (Actual)
Study Completion Date
September 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
The Center for Mind-Body Medicine, Eskenazi Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive Disorder
Keywords
Depression, Adolescent, mind-body-skills, group therapy, primary care

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mind-body-skills intervention
Arm Type
Experimental
Arm Description
mind-body-skills group intervention offered weekly for 10 weeks
Intervention Type
Behavioral
Intervention Name(s)
mind-body-skills group
Intervention Description
mind-body skills group program incorporates meditation, guided imagery, breathing techniques, autogenic training, biofeedback, genograms, and self-expression through words, drawings, and movement
Primary Outcome Measure Information:
Title
Change in Children's Depression Inventory-2 (CDI-2) scores
Description
self report long version (28 items) to assess the presence and severity of depressive symptoms in children
Time Frame
from baseline to within one month after end of intervention
Title
Change in Children's Depression Inventory-2 (CDI-2) scores
Description
self report long version (28 items) to assess the presence and severity of depressive symptoms in children
Time Frame
from baseline to approximately 3 months after end of intervention
Secondary Outcome Measure Information:
Title
Change in Patient Health Questionnaire-9 (PHQ-9) score
Description
self report (9 questions) to screen for the presence and severity of depression
Time Frame
from baseline to within one month after end of intervention
Title
Change in Patient Health Questionnaire-9 (PHQ-9) score
Description
self report (9 questions) to screen for the presence and severity of depression
Time Frame
from baseline to approximately 3 months after end of intervention
Title
Change in Rumination Subscale of the Children's Response Style Questionnaire Score
Description
self report (13 questions) of rumination symptoms
Time Frame
from baseline to within one month after end of intervention
Title
Change in Rumination Subscale of the Children's Response Style Questionnaire Score
Description
self report (13 questions) of rumination symptoms
Time Frame
from baseline to approximately 3 months after end of intervention
Title
Change in Mindful Attention Awareness Scale-Adolescent (MAAS) score
Description
self report (14 questions) designed to assess open or receptive awareness of and attention to what is taking place in the present
Time Frame
from baseline to within one month after end of intervention
Title
Change in Mindful Attention Awareness Scale-Adolescent (MAAS) score
Description
self report (14 questions) designed to assess open or receptive awareness of and attention to what is taking place in the present
Time Frame
from baseline to approximately 3 months after end of intervention
Title
Change in Self-Efficacy Questionnaire for Depression in Adolescents (SEQ-DA) score
Description
self report (12 items) designed to measure self-perceived ability to cope with depressive symptoms
Time Frame
from baseline to within one month after end of intervention
Title
Change in Self-Efficacy Questionnaire for Depression in Adolescents (SEQ-DA) score
Description
self report (12 items) designed to measure self-perceived ability to cope with depressive symptoms
Time Frame
from baseline to approximately 3 months after end of intervention
Title
Change in Suicide Ideation Questionnaire (SIQ) score
Description
self report (30 or 15 items depending on grade level) to assess frequency of suicidal ideation
Time Frame
from baseline to within one month after end of intervention
Title
Change in Suicide Ideation Questionnaire (SIQ) score
Description
self report (30 or 15 items depending on grade level) to assess frequency of suicidal ideation
Time Frame
from baseline to approximately 3 months after end of intervention
Title
Acceptability Questionnaire
Description
self report (15 items) intervention acceptability assessment of usefulness and helpfulness of the intervention
Time Frame
within one month after end of intervention
Title
Acceptability Questionnaire
Description
self report (15 items) intervention acceptability assessment of usefulness and helpfulness of the intervention
Time Frame
approximately 3 months after end of intervention
Title
Acceptability Questionnaire - open-ended questions for qualitative analyses
Description
3 open-ended questions to gather qualitative data about the usefulness and helpfulness of the intervention
Time Frame
within one month after end of intervention
Title
Acceptability Questionnaire - open-ended questions for qualitative analyses
Description
3 open-ended questions to gather qualitative data about the usefulness and helpfulness of the intervention
Time Frame
approximately 3 months after end of intervention
Title
Change in Hope Scale Score
Description
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
Time Frame
from baseline to within one month after end of intervention
Title
Change in Hope Scale Score
Description
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
Time Frame
from baseline to approximately 3 months after end of intervention
Title
Change in Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) Score
Description
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
Time Frame
from baseline to within one month after end of intervention
Title
Change in Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) Score
Description
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
Time Frame
from baseline to approximately 3 months after end of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle P Salyers, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskenazi Health Primary Care
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34706710
Citation
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.
Results Reference
derived

Learn more about this trial

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

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