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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ ~14-22 weeks

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ExeterOTHER

184 Previous Clinical Trials

1,369,591 Total Patients Enrolled

7 Trials studying Depression

1,689 Patients Enrolled for Depression

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,584 Total Patients Enrolled

666 Trials studying Depression

251,401 Patients Enrolled for Depression

University of UtahLead Sponsor

1,099 Previous Clinical Trials

1,778,506 Total Patients Enrolled

23 Trials studying Depression

2,234 Patients Enrolled for Depression

Media Library

Rumination-Focused CBT (Cognitive Behavioral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03859297 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people can take part in this experiment at any given time?

"Affirmative, the details shared on clinicaltrials.gov demonstrate that this research endeavour is in need of participants. It was first announced on May 1st 2019 and most recently updated June 1st 2022 with a goal to enlist 183 individuals from one site."

Answered by AI

Are investigators still seeking individuals to participate in the trial?

"Affirmative. Data on clinicaltrials.gov reveals that this research endeavour, which was first published in May of 2019, is presently seeking participants. 183 individuals must be enlisted from a single site for the experiment to commence."

Answered by AI

Is this investigation welcoming participants who are 45 years or older?

"The lower threshold for this medical experiment is 14, while the upper limit of age eligibility is 17."

Answered by AI

Is it possible for me to participate in this medical trial?

"The eligibility requirements for this clinical trial necessitate that participants have an affective disorder and are between 14 to 17 years old. Approximately 183 applicants can be accepted into the study."

Answered by AI