Recruiting

Observational Study

Sponsor:

Ohio State University

Code:

NCT03859297

Conditions

Major Depressive Disorder

Mood Disorders

Eligibility Criteria

Sex: All

Age: 14 - 17

Healthy Volunteers: Not accepted

Interventions

Rumination-Focused CBT

Relaxation-based Therapy

Study Details

Brief summary:

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.

Conditions

Major Depressive Disorder

Mood Disorders

Study ID

NCT03859297

Start date

May 1, 2019

Status verified date

Aug, 2025

Completion date

Mar 2, 2029

Anticipated

Primary completion date

Apr 14, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Study Design

Enrollment

183 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Rumination-Focused CBT

RF-CBT is a manual-based treatment for prevention of depression, includes focus on ruminations, mental habits, concreteness training, and mindfulness.

no intervention: Treatment as Usual

Participants are allowed to continue any therapy outside of the treatment study.

active comparator: Relaxation-based therapy

RelaxT includes an active comparison treatment that can be used to monitor and modify physiological responses to stress

Interventions

Rumination-Focused CBT

RF-CBT targets rumination and other maladaptive forms of emotion regulation such as suppression and avoidance and provides skills training in effectively coping with rumination. RF-CBT specifically targets rumination through psychoeducation, adopting a functional analytic approach to the learned habitual behavior of rumination, and a focus on shifting process style. The adolescent is taught to notice triggers to ruminate as well as the consequences of rumination and to shift into practicing a more adaptive strategy such as an attention training exercise, behavioral activation, thinking in a concrete way, or active problem-solving. RF-CBT directly teaches adolescents to recognize rumination or "when the participant gets stuck in their head" and to notice the influence this has on their mood.

Relaxation-based Therapy

Sessions will include progressive muscle relaxation, simple breathing techniques, and guided imagery that focus on bodily and somatic relaxation. Adolescents randomized to Relaxation Therapy (RelaxT) will also receive exercises to do as homework in between sessions, parallel to the RF-CBT group.

Primary outcome measure

  • Rumination Responsiveness Scale (RRS) [ Time Frame: ~14-22 weeks ]
  • Resting state functional magnetic resonance imaging (fMRI) connectivity of Default mode network to cognitive control network. [ Time Frame: ~14-22 weeks ]

Central Contacts and Locations

Central contacts

Scott A Langenecker, Ph.D.

734-276-3889scott.langenecker@osumc.edu

Caty Escobar, M.S.

301-648-3426caty.escobar@osumc.edu

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Mindy Westlund Schreiner, Ph.D.

614-722-6872mindy.westlundschreiner@nationwidechildrens.org

Hannah Ollech, B.S.

hannah.ollech@nationwidechildrens.org

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Scott A Langenecker, Ph.D.

scott.langenecker@osumc.edu

Caty Escobar, M.S.

301-648-3426caty.escobar@osumc.edu

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Brian Mickey, Ph.D.

801-587-3297brian.mickey@utah.edu

More Information

Sponsor

Ohio State University

Last update posted

Aug 11, 2025

Last verified

Aug, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-08-11.