RECRUITING

Mechanisms of Rumination Change in Adolescent Depression

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

This study will evaluate whether a newer treatment, rumination-focused cognitive behavioral treatment, which includes mindfulness and can be used to reduce ruminative habits, change ways in which key brain regions interact with each other (e.g.., often called connectivity), and whether these changes in habits and brain connectivity can reduce the risk for recurrence of depression in the next two years.

Official Title

Developing Rumination-focused Treatment to Reduce Risk for Depression Recurrence (RDR) in Adolescence

Quick Facts

Study Start:2019-05-01
Study Completion:2026-03-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03859297

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:14 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Previous diagnosis of Major Depressive Disorder (full or partial remission for at least two weeks) according to Diagnostic and Statistical Manual (DSM-V) criteria confirmed by the Kiddie Schedule for affective disorders (KSADSPL). Partial remission is defined as not meeting full DSM-V criteria for MDD.
  2. * RRS score above the age and sex specific mean, T \> 50).
  3. * 14-17 years of age at enrollment (accounting for 2 year follow-up),
  4. * Postpubertal (Petersen Pubertal Developmental Scale)
  5. * Youth assent and parent consent
  6. * Intellectual Quotient (IQ) \> 75, determined by Wechsler Abbreviated Scale of Intelligence (WASI)
  1. * Endorsement of suicidality with plan or intent (assessed via KSADSPL and Children's Depression Rating Scale (CDRS-R) clinical interviews. Current or past (within previous three months) plan or intent is exclusionary.
  2. * Lifetime history of conduct disorder, autism, any psychotic disorder (or episode unexplained by other known medical causes), or bipolar disorder. Eating disorder or alcohol/substance abuse within the previous 6 months. (Lifetime history of an anxiety disorder, disruptive mood dysregulation disorder or oppositional defiant disorder, Attention Deficit Hyperactivity Disorder (ADHD) will not be exclusionary).
  3. * Current treatment with RF-CBT, Cognitive Behavioral Therapy (CBT), or variants thereof, or in the last 2 years. Likewise, detail oriented therapy beyond supportive therapy (e.g., homework, cognitive restructuring), in same time window (ability to recall elements of structured therapies with CBT focus).
  4. * Metal braces or retainers, tattoos with metal, or clothing with metal fibers.
  5. * Claustrophobia
  6. * Current pregnancy - Parents will be asked this information at the phone screen. At the clinic eligibility visit, female participants will be asked about sexual activity in a private room separate from their parents using the pregnancy script/screen that the investigators have created. This script details that if a female is ineligible due to pregnancy or inadequate birth control, this information will not be disclosed to her parent(s). Participants who are sexually active will be asked about birth control method. Abstinence will be considered an approved form of contraception.
  7. * Psychotropic medication outside of antidepressants such as mood stabilizers and antipsychotics will be exclusionary. Participants may have a history of current, stable antidepressant medication use, with no changes in dose for the past four weeks, no change in specific medication for six weeks.

Contacts and Locations

Study Contact

Scott A Langenecker, Ph.D.
CONTACT
734-276-3889
scott.langenecker@osumc.edu
Caty Escobar, M.S.
CONTACT
301-648-3426
caty.escobar@osumc.edu

Principal Investigator

Scott Langenecker, Ph.D.
PRINCIPAL_INVESTIGATOR
Ohio State University

Study Locations (Sites)

Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
The Ohio State University
Columbus, Ohio, 43210
United States
University of Utah
Salt Lake City, Utah, 84108
United States

Collaborators and Investigators

Sponsor: Ohio State University

  • Scott Langenecker, Ph.D., PRINCIPAL_INVESTIGATOR, Ohio State 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 Date2019-05-01
Study Completion Date2026-03-02

Study Record Updates

Study Start Date2019-05-01
Study Completion Date2026-03-02

Terms related to this study

Keywords Provided by Researchers

  • rumination
  • depression
  • brain imaging
  • cognitive behavioral therapy
  • rumination focused cognitive behavioral therapy
  • default mode network
  • rumination induction

Additional Relevant MeSH Terms

  • Major Depressive Disorder
  • Mood Disorders