Mechanisms of Rumination Change in Adolescent Depression

Recruiting now · Not applicable

Conditions studied: Major Depressive Disorder, Mood Disorders

In brief

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.

Key facts

Study ID

NCT03859297

Run by

Ohio State University

People needed

183

Starts

2019-05-01

Expected to finish

2029-03-02

Last updated by the study team

2025-08-11

Who can join

Age: 14 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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).
• 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.
• 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.

Where it is running

• Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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