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Completed

NCT Number: NCT03363750

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Mental Disorders Mood Disorders

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskenazi Health Primary Care

Indianapolis, Indiana, 46254, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mind-body-skills group

Behavioral

mind-body skills group program incorporates meditation, guided imagery, breathing techniques, autogenic training, biofeedback, genograms, and self-expression through words, drawings, and movement

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Eskenazi Health
  • The Center for Mind-Body Medicine

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 6, 2017
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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