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NCT03859297Recruiting

Mechanisms of Rumination Change in Adolescent Depression

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

Source: ClinicalTrials.gov · Last updated 11 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
183 (estimated)
First submitted
27 Feb 2019
Start date
1 May 2019
Primary completion date
14 Apr 2028
Lead sponsor
Ohio State University
Diseases
Depression
NCT number
NCT03859297

What you commit to

  • Study type: Interventional
  • Planned participants: 183
  • From 1 May 2019 to the primary completion date, 14 Apr 2028
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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).
  • 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).

Other illness

  • 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.

Other

  • Metal braces or retainers, tattoos with metal, or clothing with metal fibers.
  • Claustrophobia
  • 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.

Who the study is looking for

  • 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.
  • RRS score above the age and sex specific mean, T \> 50).
  • 14-17 years of age at enrollment (accounting for 2 year follow-up),
  • Postpubertal (Petersen Pubertal Developmental Scale)
  • Youth assent and parent consent
  • Intellectual Quotient (IQ) \> 75, determined by Wechsler Abbreviated Scale of Intelligence (WASI)

Age in the registry: 14 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nationwide Children's Hospital
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
The Ohio State University
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
University of Utah
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.