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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03816215
Other study ID # IRB00053435
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 3, 2019
Est. completion date August 1, 2020

Study information

Verified date March 2020
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date August 1, 2020
Est. primary completion date August 1, 2020
Accepts healthy volunteers No
Gender All
Age group 14 Years to 20 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States Private practice Winston-Salem North Carolina
United States TriCare, PA Winston-Salem North Carolina
United States Trinity Center, Inc Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (6)

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

Beesdo K, Höfler 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. — View 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. Epub 2005 Sep 30. Review. — View Citation

Gudayol-Ferré E, Peró-Cebollero M, González-Garrido AA, Guàrdia-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. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Experience in Volunteering 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
Primary Participant recruitment Number of participants screened (reported by clinical mental health providers) 6 months
Primary Participant retention Number of participants retained in full study 6 months
Primary 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 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. 6 months
Secondary 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). 6 months
Secondary Beck Hopelessness Inventory Beck Hopelessness Inventory will be used (scored from 1-20; higher score denotes worse outcome). 6 months
Secondary Self-efficacy NIH toolbox measure from 1 (never) to 5 (very often); scores will be averaged and high score indicates more self-efficacy. 6 months
Secondary 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. 6 months
Secondary 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. 6 months
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