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Cognitive Behavioral Therapy

Rumination-Focused Cognitive Behavioural Therapy for Depression (RuMeChange Trial)

N/A
Recruiting
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
14-17 years of age at enrollment (accounting for 2 year follow-up).
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ~14-22 weeks
Awards & highlights

RuMeChange Trial Summary

This trial will test whether a newer treatment that includes mindfulness can help reduce ruminative habits and change brain connectivity, which may help reduce the risk for depression relapse.

Who is the study for?
Adolescents aged 14-17 with a past diagnosis of Major Depressive Disorder, currently in full or partial remission. They must have higher than average rumination scores and be postpubertal with an IQ over 75. Exclusions include certain mental health conditions, recent therapy similar to those being tested, metal implants that affect MRI scans, current pregnancy or risk thereof without contraception, and severe suicidality.Check my eligibility
What is being tested?
The trial is testing relaxation-based therapy versus rumination-focused cognitive behavioral treatment (RF-CBT) for adolescents who have had depression. It aims to see if RF-CBT can reduce ruminative thinking and alter brain connectivity patterns to lower the chance of depression returning within two years.See study design
What are the potential side effects?
Since this trial involves psychological therapies rather than medication, typical side effects might include temporary increases in distress or anxiety as participants engage with their thoughts during treatment sessions.

RuMeChange Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 14 and 17 years old.
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I was diagnosed with Major Depressive Disorder but have been in remission for at least two weeks.
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I have gone through puberty.
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My risk score is higher than average for my age and sex.

RuMeChange Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~~14-22 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and ~14-22 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Resting state functional magnetic resonance imaging (fMRI) connectivity of Default mode network to cognitive control network.
Rumination Responsiveness Scale (RRS)

RuMeChange Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Rumination-Focused CBTExperimental Treatment1 Intervention
RF-CBT is a manual-based treatment for prevention of depression, includes focus on ruminations, mental habits, concreteness training, and mindfulness.
Group II: Treatment as UsualActive Control1 Intervention
Participants are allowed to continue any therapy outside of the treatment study.
Group III: Relaxation-based therapyActive Control1 Intervention
RelaxT includes an active comparison treatment that can be used to monitor and modify physiological responses to stress

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Cognitive-behavioral therapies (CBTs) and mindfulness-based cognitive therapies (MBCTs) are common treatments for depression that focus on altering negative thought patterns and improving emotional regulation. These therapies work by helping patients identify and challenge ruminative thoughts, which are repetitive and negative thinking patterns that can exacerbate depression. By reducing these ruminative habits, CBTs and MBCTs can alter brain connectivity, particularly in regions associated with mood regulation and cognitive control. This is important for depression patients as it can lead to improved mood, reduced symptoms, and a lower risk of recurrence, ultimately enhancing their overall quality of life.
Cognitive predictors of change in cognitive behaviour therapy and mindfulness-based cognitive therapy for depression.Clinical outcome of rumination syndrome in adults without psychiatric illness: a prospective study.

Find a Location

Who is running the clinical trial?

University of ExeterOTHER
188 Previous Clinical Trials
1,367,295 Total Patients Enrolled
7 Trials studying Depression
1,689 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,807 Previous Clinical Trials
2,665,483 Total Patients Enrolled
673 Trials studying Depression
253,236 Patients Enrolled for Depression
University of UtahLead Sponsor
1,108 Previous Clinical Trials
1,788,236 Total Patients Enrolled
23 Trials studying Depression
2,235 Patients Enrolled for Depression

Media Library

Rumination-Focused CBT (Cognitive Behavioral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03859297 — N/A
~26 spots leftby Apr 2025