Volunteering as an Intervention to Reduce Depression Among Adolescents

• ClinicalTrials.gov Identifier: NCT03816215
• Recruitment Status: Completed
• First Posted: January 25, 2019
• Last Update Posted: March 2, 2021
• Sponsor: Wake Forest University Health Sciences
• Information provided by (Responsible Party): Wake Forest University Health Sciences

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.

Condition or disease	Intervention/treatment	Phase
Depression; Adolescent Behavior; Depressive Symptoms	Behavioral: Volunteer experience	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Volunteering as an Intervention to Reduce Depression Among Adolescents: Investigating Neurobiological Mechanisms
• Actual Study Start Date: June 3, 2019
• Actual Primary Completion Date: August 1, 2020
• Actual Study Completion Date: August 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Adolescent Participants; Participants will be assigned to participate in community service (from a menu of options) for 30 hours.	Behavioral: Volunteer experience; 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.

Outcome Measures

Primary Outcome Measures :

1. Participant recruitment [ Time Frame: 6 months ]
   Number of participants screened (reported by clinical mental health providers)
2. Participant retention [ Time Frame: 6 months ]
   Number of participants retained in full study
3. 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

Secondary Outcome Measures :

1. 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.
2. 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).
3. Beck Hopelessness Inventory [ Time Frame: 6 months ]
   Beck Hopelessness Inventory will be used (scored from 1-20; higher score denotes worse outcome).
4. 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.
5. 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. 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.

Other Outcome Measures:

1. 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).

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 20 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, North Carolina

Trinity Center, Inc

Winston-Salem, North Carolina, United States, 27101

TriCare, PA

Winston-Salem, North Carolina, United States, 27103

Private practice

Winston-Salem, North Carolina, United States, 27106

Sponsors and Collaborators

Wake Forest University Health Sciences

Investigators

• Principal Investigator: Parissa Ballard, PhD; Wake Forest University Health Sciences

  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:

Informed Consent Form  [PDF] June 12, 2020

More Information

Publications:

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.

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.

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.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT03816215
• Other Study ID Numbers: IRB00053435
• First Posted: January 25, 2019
• Last Update Posted: March 2, 2021
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:

Adolescents; FMRI; volunteerism

Additional relevant MeSH terms:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders