NCT03816215

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

June 3, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

March 2, 2021

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

January 22, 2019

Last Update Submit

March 1, 2021

Conditions

DepressionAdolescent BehaviorDepressive Symptoms

Keywords

AdolescentsFMRIvolunteerism

Outcome Measures

Primary Outcomes (3)

  • Participant recruitment

    Number of participants screened (reported by clinical mental health providers)

    6 months

  • Participant retention

    Number of participants retained in full study

    6 months

  • 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

    6 months

Secondary Outcomes (6)

  • Strength of Connectivity in DMN (Default Mode Network)

    6 months

  • Hope scale (Abler et al., 2017)

    6 months

  • Beck Hopelessness Inventory

    6 months

  • Self-efficacy

    6 months

  • Orientation Toward Others

    6 months

  • +1 more secondary outcomes

Other Outcomes (1)

  • Experience in Volunteering

    6 months

Study Arms (1)

Adolescent Participants

EXPERIMENTAL

Participants will be assigned to participate in community service (from a menu of options) for 30 hours.

Behavioral: Volunteer experience

Interventions

Volunteer experienceBEHAVIORAL

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.

Adolescent Participants

Eligibility Criteria

Age14 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Trinity Center, Inc

Winston-Salem, North Carolina, 27101, United States

Location

TriCare, PA

Winston-Salem, North Carolina, 27103, United States

Location

Private practice

Winston-Salem, North Carolina, 27106, United States

Location

Related Publications (6)

  • Beck, J. S. (2011). Cognitive behavior therapy: Basics and beyond: Guilford Press

    BACKGROUND

  • 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.

    PMID: 19689506BACKGROUND

  • 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.

    PMID: 16199119BACKGROUND

  • 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.

    PMID: 26578927BACKGROUND

  • 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.

    PMID: 11430842BACKGROUND

  • 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.

    PMID: 19171889BACKGROUND

MeSH Terms

Conditions

DepressionAdolescent Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Parissa Ballard, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2019

First Posted

January 25, 2019

Study Start

June 3, 2019

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

March 2, 2021

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)