NCT03859297 · Ohio State University
Mechanisms of Rumination Change in Adolescent Depression
(RuMeChange)
What this study is about
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..
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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.
Interventions
BEHAVIORAL
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.
BEHAVIORAL
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 measures
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Columbus, Ohio
- Salt Lake City, Utah
Collaborators
University of Exeter, National Institute of Mental Health (NIMH), University of Utah, Nationwide Children's Hospital, Utah Center for Evidence Based Treatment
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 11, 2025 · Source of record for eligibility and locations