Clinical trial NCT03363750: Study of Mind-Body Skills Groups for Adolescents With Depression in Primary Care
Official title: Pilot Study of Mind-Body Skills Groups for Adolescents With Depression in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Depressive Disorder
Keywords: Depression
Adolescent
mind-body-skills
group therapy
primary care
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: The Center for Mind-Body Medicine
name: Eskenazi Health
First posted: 2017-12-06
Enrollment: 49
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Change in Children's Depression Inventory-2 (CDI-2) scores
timeFrame: from baseline to within one month after end of intervention
measure: Change in Children's Depression Inventory-2 (CDI-2) scores
timeFrame: from baseline to approximately 3 months after end of intervention
Secondary outcomes:
measure: Change in Patient Health Questionnaire-9 (PHQ-9) score
timeFrame: from baseline to within one month after end of intervention
measure: Change in Patient Health Questionnaire-9 (PHQ-9) score
timeFrame: from baseline to approximately 3 months after end of intervention
measure: Change in Rumination Subscale of the Children's Response Style Questionnaire Score
timeFrame: from baseline to within one month after end of intervention
measure: Change in Rumination Subscale of the Children's Response Style Questionnaire Score
timeFrame: from baseline to approximately 3 months after end of intervention
measure: Change in Mindful Attention Awareness Scale-Adolescent (MAAS) score
timeFrame: from baseline to within one month after end of intervention
measure: Change in Mindful Attention Awareness Scale-Adolescent (MAAS) score
timeFrame: from baseline to approximately 3 months after end of intervention
measure: Change in Self-Efficacy Questionnaire for Depression in Adolescents (SEQ-DA) score
timeFrame: from baseline to within one month after end of intervention
measure: Change in Self-Efficacy Questionnaire for Depression in Adolescents (SEQ-DA) score
timeFrame: from baseline to approximately 3 months after end of intervention
measure: Change in Suicide Ideation Questionnaire (SIQ) score
timeFrame: from baseline to within one month after end of intervention
measure: Change in Suicide Ideation Questionnaire (SIQ) score
timeFrame: from baseline to approximately 3 months after end of intervention
measure: Acceptability Questionnaire
timeFrame: within one month after end of intervention
measure: Acceptability Questionnaire
timeFrame: approximately 3 months after end of intervention
measure: Acceptability Questionnaire - open-ended questions for qualitative analyses
timeFrame: within one month after end of intervention
measure: Acceptability Questionnaire - open-ended questions for qualitative analyses
timeFrame: approximately 3 months after end of intervention
measure: Change in Hope Scale Score
timeFrame: from baseline to within one month after end of intervention
measure: Change in Hope Scale Score
timeFrame: from baseline to approximately 3 months after end of intervention
measure: Change in Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) Score
timeFrame: from baseline to within one month after end of intervention
measure: Change in Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) Score
timeFrame: from baseline to approximately 3 months after end of intervention
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Health Primary Care
state: Indiana
Study officials:
affiliation: Indiana University
name: Michelle P Salyers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.