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DepressionNCT03363750

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

A study testing mind-body-skills group in people with Depression and Depressive Disorder, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Depression, Depressive Disorder
What is being tested?
mind-body-skills group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteUnited States
Study dates
25 Jan 2018to 4 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Eskenazi Health Primary Care

    Indianapolis, Indiana, 46254

Other trials in United States

About this study

Official title: Pilot 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.

Being tested
mind-body-skills group
Keywords
Depression, Adolescent, mind-body-skills, group therapy, primary care
Medical subject headings
Depression, Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mind-body-skills groupBehavioural

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

Study groups in NCT03363750
Study groupRoleWhat they receive
mind-body-skills interventionExperimentalmind-body-skills group intervention offered weekly for 10 weeks
Receives: Behavioral: mind-body-skills group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: from baseline to within one month after end of intervention

  2. 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

    Measured: from baseline to approximately 3 months after end of intervention

Secondary outcomes (18)

  1. Change in Patient Health Questionnaire-9 (PHQ-9) score

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

    Measured: from baseline to within one month after end of intervention

  2. Change in Patient Health Questionnaire-9 (PHQ-9) score

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

    Measured: from baseline to approximately 3 months after end of intervention

  3. Change in Rumination Subscale of the Children's Response Style Questionnaire Score

    self report (13 questions) of rumination symptoms

    Measured: from baseline to within one month after end of intervention

  4. Change in Rumination Subscale of the Children's Response Style Questionnaire Score

    self report (13 questions) of rumination symptoms

    Measured: from baseline to approximately 3 months after end of intervention

  5. 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

    Measured: from baseline to within one month after end of intervention

  6. 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

    Measured: from baseline to approximately 3 months after end of intervention

  7. 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

    Measured: from baseline to within one month after end of intervention

  8. 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

    Measured: from baseline to approximately 3 months after end of intervention

  9. Change in Suicide Ideation Questionnaire (SIQ) score

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

    Measured: from baseline to within one month after end of intervention

  10. Change in Suicide Ideation Questionnaire (SIQ) score

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

    Measured: from baseline to approximately 3 months after end of intervention

  11. Acceptability Questionnaire

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

    Measured: within one month after end of intervention

  12. Acceptability Questionnaire

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

    Measured: approximately 3 months after end of intervention

  13. Acceptability Questionnaire - open-ended questions for qualitative analyses

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

    Measured: within one month after end of intervention

  14. Acceptability Questionnaire - open-ended questions for qualitative analyses

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

    Measured: approximately 3 months after end of intervention

  15. 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

    Measured: from baseline to within one month after end of intervention

  16. 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

    Measured: from baseline to approximately 3 months after end of intervention

  17. 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

    Measured: from baseline to within one month after end of intervention

  18. 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

    Measured: from baseline to approximately 3 months after end of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2017
  2. Study start25 Jan 2018
  3. Primary completion4 Sep 2019
  4. Study completion4 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03363750
Sponsor's protocol ID
1707293729
Status last verified
Mar 2020
First submitted
21 Nov 2017
Last updated
10 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34706710

Questions about this trial

What is this clinical trial studying?

A study testing mind-body-skills group in people with Depression and Depressive Disorder, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Children's Depression Inventory-2 (CDI-2) scores (time frame: from baseline to within one month after end of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03363750, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.

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