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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03363750
• Other study ID #: 1707293729
• Status: Completed
• Phase: N/A
• Start date: January 25, 2018
• Est. completion date: September 4, 2019

Study information

• Verified date: March 2020
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 4, 2019
• Est. primary completion date: September 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Eskenazi Health Primary Care	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	Eskenazi Health, The Center for Mind-Body Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	from baseline to within one month after end of intervention
Primary	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	from baseline to approximately 3 months after end of intervention
Secondary	Change in Patient Health Questionnaire-9 (PHQ-9) score	self report (9 questions) to screen for the presence and severity of depression	from baseline to within one month after end of intervention
Secondary	Change in Patient Health Questionnaire-9 (PHQ-9) score	self report (9 questions) to screen for the presence and severity of depression	from baseline to approximately 3 months after end of intervention
Secondary	Change in Rumination Subscale of the Children's Response Style Questionnaire Score	self report (13 questions) of rumination symptoms	from baseline to within one month after end of intervention
Secondary	Change in Rumination Subscale of the Children's Response Style Questionnaire Score	self report (13 questions) of rumination symptoms	from baseline to approximately 3 months after end of intervention
Secondary	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	from baseline to within one month after end of intervention
Secondary	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	from baseline to approximately 3 months after end of intervention
Secondary	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	from baseline to within one month after end of intervention
Secondary	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	from baseline to approximately 3 months after end of intervention
Secondary	Change in Suicide Ideation Questionnaire (SIQ) score	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
Secondary	Change in Suicide Ideation Questionnaire (SIQ) score	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
Secondary	Acceptability Questionnaire	self report (15 items) intervention acceptability assessment of usefulness and helpfulness of the intervention	within one month after end of intervention
Secondary	Acceptability Questionnaire	self report (15 items) intervention acceptability assessment of usefulness and helpfulness of the intervention	approximately 3 months after end of intervention
Secondary	Acceptability Questionnaire - open-ended questions for qualitative analyses	3 open-ended questions to gather qualitative data about the usefulness and helpfulness of the intervention	within one month after end of intervention
Secondary	Acceptability Questionnaire - open-ended questions for qualitative analyses	3 open-ended questions to gather qualitative data about the usefulness and helpfulness of the intervention	approximately 3 months after end of intervention
Secondary	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	from baseline to within one month after end of intervention
Secondary	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	from baseline to approximately 3 months after end of intervention
Secondary	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	from baseline to within one month after end of intervention
Secondary	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	from baseline to approximately 3 months after end of intervention