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NCT Number: NCT03859297

Mechanisms of Rumination Change in Adolescent Depression

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.

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Key information

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital, Columbus, Ohio, United States

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About this study

Major Depressive Disorder (MDD) is a disease that has it's onset in childhood and early adolescence for many. Treatments in adolescence tend to be acute and short-term. Unfortunately, between half and three quarters of adolescents who have a first episode of MDD will go to have a second episode within the next two years. Studies in adults suggest that maintenance treatments or preventative treatments can lower these risks and delay or stop recurrences.

The present study will use a preventative strategy, rumination-focused CBT (RF-CBT) to delay or stop the onset of another MD episode for at least two years.

For the first 2 years of the study, adolescents with a history of MDD who are currently well will be randomly selected for either treatment with RF-CBT or just treatment as usual in the first two years of the study.

In the last 3 years of the study, these adolescents will be randomized to either RF-CBT or Relaxation Therapy above and beyond TAU (Treatment as Usual). Brain, cognitive, and self-report measurements are collected before during and after the intervention to evaluate what brain and rumination changes occur, and which adolescents benefit the most from the treatment.

What will happen.

  • The Investigators determine if the child is eligible (see criteria below for 14-17 year olds with history of MDD.
  • The Investigators complete pre-intervention assessments with the child that include
  • brain imaging
  • tests of cognitive skills and emotion processing, including rumination
  • questionnaires about how the adolescent thinks and responds to situations, similar questionnaires in at least one parent/guardian
  • measurement of sleep using a handheld wristwatch (called an actigraph - optional).
  • randomization (chance assignment) in years 1-2 to either rumination focused cognitive behavioral therapy (RF-CBT) or assessment only for a 10-14 session intervention. Treatment as usual continues for all adolescents. In years 3-5, chance assignment is to RF-CBT or Relaxation Therapy.
  • repeat assessments after the intervention period. The cognitive skills and emotion processing are also assessed during the middle of the intervention period.
  • brain imaging
  • tests of cognitive skills and emotion processing, including rumination
  • questionnaires about how the adolescent thinks and responds to situations, similar questionnaires in at least one parent/guardian
  • measurement of sleep using a handheld wristwatch (called an actigraph - optional).
  • follow-up assessments to determine any changes, recurrence of depression, new treatments for the next two years.
  • questionnaires
  • interviews

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rumination-Focused CBT

Behavioral

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

Behavioral

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 outcomes

  1. Rumination Responsiveness Scale (RRS)

    Time frame: ~14-22 weeks

    RRS is a scale developed by Dr. Susan Nolan-Hoeksema that is used to determine pre-post reductions in rumination after RF-CBT.

    The RRS is the Rumination Responsiveness Scale. Scores range from a low of 22 to a high of 88 on the 232 item scale. Higher scores indicate more difficulties with rumination. Higher rumination has been reported in a number of samples of both active and remitted MDD.

    The outcome is a reliable change index decline of at least 1/2 standard deviation in the RF-CBT group relative to the AO and RelaxT arms.

    In our preliminary study, the RRS declined from 52.88 to 43 (Jacobs et al., 2016). An age matched control group had a mean score of 30.4 (7.1), Burkhouse et al., 2016.

  2. Resting state functional magnetic resonance imaging (fMRI) connectivity of Default mode network to cognitive control network.

    Time frame: ~14-22 weeks

    Using seed based approaches with the posterior cingulate gyrus and medial prefrontal cortex, the investigators will evaluate if RF-CBT and not AO or RelaxT, results in decreases in rs-fMRI connectivity to cognitive control network nodes, particularly right inferior frontal and temporal gyri.

Study contacts

Contact information is provided by the study sponsor or research team.

Caty Escobar, M.S.

CONTACT

[email protected]

301-648-3426

Scott A Langenecker, Ph.D.

CONTACT

[email protected]

734-276-3889

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Nationwide Children's Hospital
  • University of Exeter
  • University of Utah
  • Utah Center for Evidence Based Treatment

Registry information

Official study title

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

Acronym: RuMeChange

Important dates

Study start
2019
Primary completion
2028
Study completion
2029
First posted
Mar 1, 2019
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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