RECRUITING

Mechanisms of Behavioral Activation (BA)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators will be comparing brain (neural) activation of depressed adolescent patients before, during and after a course of Behavioral Activation (BA) therapy using functional magnetic resonance imaging (fMRI). In particular, the project seeks to determine whether BA targets different neural mechanisms for behavioral avoidance associated with low motivation as compared to threat avoidance. A group of healthy controls will also be scanned as a comparator group for behavioral and imaging measures.

Official Title

Multi-level Mechanisms of Behavioral Activation Therapy for Adolescent Depression

Quick Facts

Study Start:2023-01-30
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05548244

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Male and female adolescents ages 15-17;
  2. * current MDD diagnosis as determined by K-SADS-PL,
  3. * CDRS-R raw score \> 45 (T-score \> 65) at baseline;
  4. * estimated full scale IQ \> 80 as determined by the WASI-II;
  5. * able to receive outpatient care;
  6. * willing to not partake in other psychosocial treatments;
  7. * not taking psychotropic medications in the two weeks (four weeks for fluoxetine) prior to consent, with the exception of psychostimulant medication prescribed for the treatment of ADHD.
  8. * Additionally, depressed patients must have access to required technology (e.g. smart phone, tablet, or desktop computer) to complete the EMA portion of the study.
  9. * Healthy controls cannot not meet criteria for MDD and their CDRS-R raw score must be below 28; T-score \< 52).
  1. * Current or past diagnosis of bipolar, schizophrenia, schizophreniform, schizoaffective disorders, or psychosis NOS;
  2. * current diagnosis of developmental disorder, severe conduct disorder, life-threatening anorexia, OCD, or autism-spectrum disorders;
  3. * taking psychotropic medications prior to entry;
  4. * estimated IQ \< 80; alcohol/drug dependence or abuse within the last 3 months;
  5. * potential/confirmed neurological disorder or epilepsy;
  6. * claustrophobia;
  7. * presence of a medical condition that precludes fMRI;
  8. * endorsement of imminent and serious suicidality;
  9. * medical conditions that take precedence over the presence of MDD;
  10. * pregnancy;
  11. * substance use (excluding nicotine) within two weeks of the fMRI scan;
  12. * left-handedness;
  13. * nicotine use within 3 hours of the fMRI scan;
  14. * history of traumatic brain injury or of being unconscious for more than 30 minutes;
  15. * a stimulant regime for ADHD which has changed within 30 days of the fMRI scan.
  16. * Non-compliance (i.e. \<70% completion) or inability (i.e. lack of smartphone device) to complete the 3 assessment periods of EMA.

Contacts and Locations

Study Contact

Wade E Craighead, PhD
CONTACT
4047273287
ecraigh@emory.edu
Michael Treadway, PhD
CONTACT
mtreadway@emory.edu

Principal Investigator

Wade E Craighead, PhD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Emory University
Atlanta, Georgia, 30322
United States
Facility for Education and Research in Neuroscience (FERN)
Atlanta, Georgia, 30322
United States
Child and Adolescent Mood Program (CAMP)
Atlanta, Georgia, 30329
United States

Collaborators and Investigators

Sponsor: Emory University

  • Wade E Craighead, PhD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-30
Study Completion Date2027-05

Study Record Updates

Study Start Date2023-01-30
Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

  • Behavioral Activation
  • fMRI

Additional Relevant MeSH Terms

  • Depression