DepressionNCT03816215
Volunteering as an Intervention to Reduce Depression Among Adolescents
A study testing Volunteer experience in people with Depression and Adolescent Behavior, run by Wake Forest University Health Sciences at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 20 years
- Conditions the study is for
- Depression, Adolescent Behavior, Depressive Symptoms
- What is being tested?
- Volunteer experience
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Jun 2019to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Trinity Center, Inc
Winston-Salem, North Carolina, 27101
TriCare, PA
Winston-Salem, North Carolina, 27103
Private practice
Winston-Salem, North Carolina, 27106
About this study
Official title: Volunteering as an Intervention to Reduce Depression Among Adolescents: Investigating Neurobiological Mechanisms
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.
Read the 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.
- Conditions
- Depression, Adolescent Behavior, Depressive Symptoms
- Being tested
- Volunteer experience
- Keywords
- Adolescents, FMRI, volunteerism
- Medical subject headings
- Depression, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volunteer experienceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Adolescent Participants | Experimental | Participants will be assigned to participate in community service (from a menu of options) for 30 hours. Receives: Behavioral: Volunteer experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant recruitment
Number of participants screened (reported by clinical mental health providers)
Measured: 6 months
Participant retention
Number of participants retained in full study
Measured: 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
Measured: 6 months
Secondary outcomes (6)
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.
Measured: 6 months
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).
Measured: 6 months
Beck Hopelessness Inventory
Beck Hopelessness Inventory will be used (scored from 1-20; higher score denotes worse outcome).
Measured: 6 months
Self-efficacy
NIH toolbox measure from 1 (never) to 5 (very often); scores will be averaged and high score indicates more self-efficacy.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start3 Jun 2019
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parissa Ballard, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816215
- Sponsor's protocol ID
- IRB00053435
- Status last verified
- Mar 2020
- First submitted
- 22 Jan 2019
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19689506Butler 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.
PubMed 16199119Gudayol-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.
PubMed 26578927Kessler 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.
PubMed 11430842Sheline 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.
PubMed 19171889
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volunteering as an Intervention to Reduce Depression Among Adolescents: Investigating Neurobiological Mechanisms
- ClinicalTrials.gov ID
- NCT03816215
- Acronym / sponsor ID
- IRB00053435
- Conditions
- Depression, Adolescent Behavior, Depressive Symptoms
- Keywords
- Adolescents, FMRI, volunteerism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescent Participants | Experimental | Behavioral: Volunteer experienceParticipants will be assigned to participate in community service (from a menu of options) for 30 hours. |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- history of recurrent depressive, anxiety or adjustment disorder episodes
- have been in treatment > 8 months
- left-handed
- expressing suicidal ideation
- claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volunteer experienceParticipants 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. | Behavioural | Adolescent Participants |
Primary outcome
Participant recruitment
Time frame: 6 months
Number of participants screened (reported by clinical mental health providers)
Participant retention
Time frame: 6 months
Number of participants retained in full study
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
6 secondary outcomes
Strength of Connectivity in DMN (Default Mode Network)
Time frame: 6 months
Hope scale (Abler et al., 2017)
Time frame: 6 months
Beck Hopelessness Inventory
Time frame: 6 months
Self-efficacy
Time frame: 6 months
Orientation Toward Others
Time frame: 6 months
Empathy
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- BackgroundBeck, J. S. (2011). Cognitive behavior therapy: Basics and beyond: Guilford Press
- Background: PubMed 19689506Beesdo 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.
- Background: PubMed 16199119Butler 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.
- Background: PubMed 26578927Gudayol-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.
- Background: PubMed 11430842Kessler 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.
- Background: PubMed 19171889Sheline 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parissa Ballard, PhD principal investigator
Wake Forest University Health Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volunteer experience in people with Depression and Adolescent Behavior, run by Wake Forest University Health Sciences at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant recruitment (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03816215, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.