- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03816215
Volunteering as an Intervention to Reduce Depression Among Adolescents
March 1, 2021 updated by: Wake Forest University Health Sciences
Volunteering as an Intervention to Reduce Depression Among Adolescents: Investigating Neurobiological Mechanisms
The purpose of the present study is to test in a preliminary manner an innovative strategy for treating depression among adolescents (alongside existing therapy) using community volunteerism.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of the present study is to test in a preliminary manner an innovative strategy for treating depression among adolescents (alongside existing therapy) using community volunteerism.
In addition, this study will test a potential mechanism by which volunteering might decrease depressive symptoms: increasing psychosocial assets, specifically decreasing self-orientation and increasing an orientation toward others.
This will be measured through self-report as well as using functional magnetic resonance imaging (fMRI).
This study will be the first study to explore how neural response patterns are potentially altered by intense experiences with volunteerism among depressed adolescents.
Study Type
Interventional
Enrollment (Actual)
9
Phase
- 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
-
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North Carolina
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Winston-Salem, North Carolina, United States, 27101
- Trinity Center, Inc
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Winston-Salem, North Carolina, United States, 27103
- TriCare, PA
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Winston-Salem, North Carolina, United States, 27106
- Private Practice
-
-
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
Ages Eligible for Study
14 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 14-20
- new mild to moderate depression diagnosis (single episode)
- new mild to moderate anxiety diagnosis
- new adjustment disorder diagnosis
- have been in treatment for < 8 months
- right-handed
Exclusion Criteria:
- history of recurrent depressive, anxiety or adjustment disorder episodes
- have been in treatment > 8 months
- left-handed
- expressing suicidal ideation
- claustrophobia
- any contraindications for completing an MRI scan
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Adolescent Participants
Participants will be assigned to participate in community service (from a menu of options) for 30 hours.
|
Participants will be assigned to a meaningful volunteer experience from a menu of local options (e.g., volunteering at an animal shelter or in a library) for 30 hours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant recruitment
Time Frame: 6 months
|
Number of participants screened (reported by clinical mental health providers)
|
6 months
|
|
Participant retention
Time Frame: 6 months
|
Number of participants retained in full study
|
6 months
|
|
Depressive symptoms (Beck Depression Inventory)
Time Frame: 6 months
|
Beck Depression Inventory to measure depressive symptoms.
Each item is rated on a 4-point scale ranging from 0 to 3. The minimum total score is 0 and the maximum total score is 63.
Higher scores denote worse outcome
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strength of Connectivity in DMN (Default Mode Network)
Time Frame: 6 months
|
Default Mode Network Connectivity will be measured using fMRI at rest and while processing emotional pictures before and after volunteering intervention.
The strength of connectivity within the DMN will be calculated by averaging attributes for each node in the DMN.
|
6 months
|
|
Hope scale (Abler et al., 2017)
Time Frame: 6 months
|
Hope scale (Abler et al., 2017) will be measured on a scale from 1 (strongly disagree) to 5 (strongly agree).
Items will be averaged; higher scores denote better outcome (more hope).
|
6 months
|
|
Beck Hopelessness Inventory
Time Frame: 6 months
|
Beck Hopelessness Inventory will be used (scored from 1-20; higher score denotes worse outcome).
|
6 months
|
|
Self-efficacy
Time Frame: 6 months
|
NIH toolbox measure from 1 (never) to 5 (very often); scores will be averaged and high score indicates more self-efficacy.
|
6 months
|
|
Orientation Toward Others
Time Frame: 6 months
|
5 point scale from 1=strongly disagree to 5=strongly agree.
Scores will be averaged; higher score denotes more orientation toward others.
|
6 months
|
|
Empathy
Time Frame: 6 months
|
IRI (Interpersonal Reactivity Index) subscale to measure empathy on a 5 point scale from 1- strongly disagree to 5 -strongly agree.
Scores will be averaged; higher score denotes more empathy.
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Experience in Volunteering
Time Frame: 6 months
|
Measured through the Inventory of Service Experience (Taylor & Pancer, 2007) on a scale from 1 (strongly disagree) to 5 (strongly agree).
Scores will be averaged for subscales of the measure.
Higher score denotes better outcomes (more positive experiences with volunteering).
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Parissa Ballard, PhD, Wake Forest University Health Sciences
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
- Butler AC, Chapman JE, Forman EM, Beck AT. The empirical status of cognitive-behavioral therapy: a review of meta-analyses. Clin Psychol Rev. 2006 Jan;26(1):17-31. doi: 10.1016/j.cpr.2005.07.003. Epub 2005 Sep 30.
- Beck, J. S. (2011). Cognitive behavior therapy: Basics and beyond: Guilford Press
- Beesdo K, Hofler M, Leibenluft E, Lieb R, Bauer M, Pfennig A. Mood episodes and mood disorders: patterns of incidence and conversion in the first three decades of life. Bipolar Disord. 2009 Sep;11(6):637-49. doi: 10.1111/j.1399-5618.2009.00738.x.
- Gudayol-Ferre E, Pero-Cebollero M, Gonzalez-Garrido AA, Guardia-Olmos J. Changes in brain connectivity related to the treatment of depression measured through fMRI: a systematic review. Front Hum Neurosci. 2015 Nov 3;9:582. doi: 10.3389/fnhum.2015.00582. eCollection 2015.
- Kessler RC, Avenevoli S, Ries Merikangas K. Mood disorders in children and adolescents: an epidemiologic perspective. Biol Psychiatry. 2001 Jun 15;49(12):1002-14. doi: 10.1016/s0006-3223(01)01129-5.
- Sheline YI, Barch DM, Price JL, Rundle MM, Vaishnavi SN, Snyder AZ, Mintun MA, Wang S, Coalson RS, Raichle ME. The default mode network and self-referential processes in depression. Proc Natl Acad Sci U S A. 2009 Feb 10;106(6):1942-7. doi: 10.1073/pnas.0812686106. Epub 2009 Jan 26.
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)
June 3, 2019
Primary Completion (Actual)
August 1, 2020
Study Completion (Actual)
August 1, 2020
Study Registration Dates
First Submitted
January 22, 2019
First Submitted That Met QC Criteria
January 24, 2019
First Posted (Actual)
January 25, 2019
Study Record Updates
Last Update Posted (Actual)
March 2, 2021
Last Update Submitted That Met QC Criteria
March 1, 2021
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00053435
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
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