Depression Clinical Trial
Official title:
Volunteering as an Intervention to Reduce Depression Among Adolescents: Investigating Neurobiological Mechanisms
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 |
Verified date | March 2020 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
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
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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