Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03363750
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : March 7, 2019
Sponsor:
Collaborators:
The Center for Mind-Body Medicine
Eskenazi Health
Information provided by (Responsible Party):
Michelle Salyers, 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.

Condition or disease Intervention/treatment Phase
Depression Depressive Disorder Behavioral: mind-body-skills group Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
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 : January 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in Children's Depression Inventory-2 (CDI-2) scores [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: within one month after end of intervention ]
    self report (15 items) intervention acceptability assessment of usefulness and helpfulness of the intervention

  12. Acceptability Questionnaire [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363750


Contacts
Layout table for location contacts
Contact: Jennifer M Garabrant 317-278-2510 jwilkers@iu.edu
Contact: Lindsey D Jones 317-278-5636 ldj2@iu.edu

Locations
Layout table for location information
United States, Indiana
Eskenazi Health Primary Care Recruiting
Indianapolis, Indiana, United States, 46254
Contact: Jennifer M Garabrant, BSW    317-278-2510    jwilkers@iu.edu   
Principal Investigator: Michelle P Salyers, PhD         
Sponsors and Collaborators
Indiana University
The Center for Mind-Body Medicine
Eskenazi Health
Investigators
Layout table for investigator information
Principal Investigator: Michelle P Salyers, PhD Indiana University

Layout table for additonal information
Responsible Party: Michelle Salyers, Professor, Indiana University
ClinicalTrials.gov Identifier: NCT03363750     History of Changes
Other Study ID Numbers: 1707293729
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michelle Salyers, Indiana University:
Depression
Adolescent
mind-body-skills
group therapy
primary care
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders