Volunteering as an Intervention to Reduce Depression Among Adolescents
Primary Purpose
Depression, Adolescent Behavior, Depressive Symptoms
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Volunteer experience
Sponsored by

About this trial
This is an interventional treatment trial for Depression focused on measuring Adolescents, FMRI, volunteerism
Eligibility Criteria
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
Sites / Locations
- Trinity Center, Inc
- TriCare, PA
- Private practice
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adolescent Participants
Arm Description
Participants will be assigned to participate in community service (from a menu of options) for 30 hours.
Outcomes
Primary Outcome Measures
Participant recruitment
Number of participants screened (reported by clinical mental health providers)
Participant retention
Number of participants retained in full study
Depressive symptoms (Beck Depression Inventory)
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
Secondary Outcome Measures
Strength of Connectivity in DMN (Default Mode Network)
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.
Hope scale (Abler et al., 2017)
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).
Beck Hopelessness Inventory
Beck Hopelessness Inventory will be used (scored from 1-20; higher score denotes worse outcome).
Self-efficacy
NIH toolbox measure from 1 (never) to 5 (very often); scores will be averaged and high score indicates more self-efficacy.
Orientation Toward Others
5 point scale from 1=strongly disagree to 5=strongly agree. Scores will be averaged; higher score denotes more orientation toward others.
Empathy
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.
Full Information
NCT ID
NCT03816215
First Posted
January 22, 2019
Last Updated
March 1, 2021
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03816215
Brief Title
Volunteering as an Intervention to Reduce Depression Among Adolescents
Official Title
Volunteering as an Intervention to Reduce Depression Among Adolescents: Investigating Neurobiological Mechanisms
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 3, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Adolescent Behavior, Depressive Symptoms
Keywords
Adolescents, FMRI, volunteerism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adolescent Participants
Arm Type
Experimental
Arm Description
Participants will be assigned to participate in community service (from a menu of options) for 30 hours.
Intervention Type
Behavioral
Intervention Name(s)
Volunteer experience
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participant recruitment
Description
Number of participants screened (reported by clinical mental health providers)
Time Frame
6 months
Title
Participant retention
Description
Number of participants retained in full study
Time Frame
6 months
Title
Depressive symptoms (Beck Depression Inventory)
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Strength of Connectivity in DMN (Default Mode Network)
Description
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.
Time Frame
6 months
Title
Hope scale (Abler et al., 2017)
Description
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).
Time Frame
6 months
Title
Beck Hopelessness Inventory
Description
Beck Hopelessness Inventory will be used (scored from 1-20; higher score denotes worse outcome).
Time Frame
6 months
Title
Self-efficacy
Description
NIH toolbox measure from 1 (never) to 5 (very often); scores will be averaged and high score indicates more self-efficacy.
Time Frame
6 months
Title
Orientation Toward Others
Description
5 point scale from 1=strongly disagree to 5=strongly agree. Scores will be averaged; higher score denotes more orientation toward others.
Time Frame
6 months
Title
Empathy
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Experience in Volunteering
Description
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).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parissa Ballard, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trinity Center, Inc
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Facility Name
TriCare, PA
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Private practice
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27106
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Beck, J. S. (2011). Cognitive behavior therapy: Basics and beyond: Guilford Press
Results Reference
background
PubMed Identifier
19689506
Citation
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.
Results Reference
background
PubMed Identifier
16199119
Citation
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.
Results Reference
background
PubMed Identifier
26578927
Citation
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.
Results Reference
background
PubMed Identifier
11430842
Citation
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.
Results Reference
background
PubMed Identifier
19171889
Citation
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.
Results Reference
background
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Volunteering as an Intervention to Reduce Depression Among Adolescents
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