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

Sponsor
Indiana University (Other)
Overall Status
Completed
CT.gov ID
NCT03363750
Collaborator
The Center for Mind-Body Medicine (Other), Eskenazi Health (Other)
49
1
1
19.3
2.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: mind-body-skills group
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Pilot Study of Mind-Body Skills Groups for Adolescents With Depression in Primary Care
Actual Study Start Date :
Jan 25, 2018
Actual Primary Completion Date :
Sep 4, 2019
Actual Study Completion Date :
Sep 4, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Children's Depression Inventory-2 (CDI-2) scores [from baseline to within one month after end of intervention]

    self report long version (28 items) to assess the presence and severity of depressive symptoms in children

  2. 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

  1. Change in Patient Health Questionnaire-9 (PHQ-9) score [from baseline to within one month after end of intervention]

    self report (9 questions) to screen for the presence and severity of depression

  2. 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

  3. Change in Rumination Subscale of the Children's Response Style Questionnaire Score [from baseline to within one month after end of intervention]

    self report (13 questions) of rumination symptoms

  4. 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

  5. Change in Mindful Attention Awareness Scale-Adolescent (MAAS) score [from baseline to within one month 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

  6. 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

  7. Change in Self-Efficacy Questionnaire for Depression in Adolescents (SEQ-DA) score [from baseline to within one month after end of intervention]

    self report (12 items) designed to measure self-perceived ability to cope with depressive symptoms

  8. 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

  9. Change in Suicide Ideation Questionnaire (SIQ) score [from baseline to within one month after end of intervention]

    self report (30 or 15 items depending on grade level) to assess frequency of suicidal ideation

  10. 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

  11. Acceptability Questionnaire [within one month after end of intervention]

    self report (15 items) intervention acceptability assessment of usefulness and helpfulness of the intervention

  12. Acceptability Questionnaire [approximately 3 months after end of intervention]

    self report (15 items) intervention acceptability assessment of usefulness and helpfulness of the intervention

  13. Acceptability Questionnaire - open-ended questions for qualitative analyses [within one month after end of intervention]

    3 open-ended questions to gather qualitative data about the usefulness and helpfulness of the intervention

  14. 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

  15. Change in Hope Scale Score [from 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

  16. 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

  17. Change in Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) Score [from 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

  18. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 17 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eskenazi Health Primary Care Indianapolis Indiana United States 46254

Sponsors and Collaborators

  • Indiana University
  • The Center for Mind-Body Medicine
  • Eskenazi Health

Investigators

  • Principal Investigator: Michelle P Salyers, PhD, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michelle Salyers, Professor, Indiana University
ClinicalTrials.gov Identifier:
NCT03363750
Other Study ID Numbers:
  • 1707293729
First Posted:
Dec 6, 2017
Last Update Posted:
Mar 10, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Michelle Salyers, Professor, Indiana University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2020