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

March 9, 2020 updated by: Michelle Salyers, Indiana University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46254
        • Eskenazi Health Primary Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
from baseline to within one month after end of intervention
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
from baseline to approximately 3 months after end of intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
from baseline to within one month after end of intervention
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
from baseline to approximately 3 months after end of intervention
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
from baseline to within one month after end of intervention
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
from baseline to approximately 3 months after end of intervention
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
from baseline to within one month after end of intervention
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
from baseline to approximately 3 months after end of intervention
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
from baseline to within one month after end of intervention
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
from baseline to approximately 3 months after end of intervention
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
from baseline to within one month after end of intervention
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
from baseline to approximately 3 months after end of intervention
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
within one month after end of intervention
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
approximately 3 months after end of intervention
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
within one month after end of intervention
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
approximately 3 months after end of intervention
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
from baseline to within one month after end of intervention
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
from baseline to approximately 3 months after end of intervention
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
from baseline to within one month after end of intervention
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
from baseline to approximately 3 months after end of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eskenazi Health
The Center for Mind-Body Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michelle P Salyers, PhD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 4, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 4, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1707293729

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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