What side effects are associated with this type of intervention?

Cognitive-behavioral therapy (CBT) and mindfulness-based therapies, such as Rumination-Focused Cognitive Behavioral Treatment (RFCBT), generally have minimal physical side effects but can sometimes cause emotional discomfort as patients confront distressing thoughts and feelings. Pharmacological treatments, particularly selective serotonin reuptake inhibitors (SSRIs), are also commonly used for depression. Common side effects of SSRIs include nausea, headache, sleep disturbances, sexual dysfunction, and increased anxiety initially. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to individual needs.

What prior FDA approvals exist?

The FDA has approved several treatments for depression, including various forms of cognitive behavioral therapy (CBT) and pharmacological options. Traditional CBT, which focuses on altering negative thought patterns and behaviors, is a cornerstone of depression treatment. Additionally, mindfulness-based cognitive therapy (MBCT), which combines CBT with mindfulness strategies, has shown efficacy in preventing depression relapse. On the pharmacological side, selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine are commonly prescribed. These treatments aim to improve mood and cognitive function, similar to the goals of Rumination-Focused Cognitive Behavioral Treatment.

What other types of research exist?

Promising novel alternatives to RFCBT for depression patients include: 1) Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells in the brain, 2) Ketamine and Esketamine treatments, which have shown rapid antidepressant effects, 3) Digital and Internet-based Cognitive Behavioral Therapy (CBT) platforms, which offer accessible and scalable treatment options, and 4) Mindfulness-Based Cognitive Therapy (MBCT), which integrates mindfulness practices to prevent relapse in recurrent depression.

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Cognitive Behavioral Therapy

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

N/A

Recruiting

Led By Scott Langenecker, Ph.D.

Research Sponsored by Ohio State University

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.

Must not have

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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ~14-22 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a special type of talk therapy can help teenagers who have had depression before by stopping them from overthinking negative thoughts. The goal is to see if this can prevent them from getting depressed again. This therapy was developed to specifically target depressive rumination and has shown effectiveness in reducing depressive symptoms and relapse rates.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently in or have recently had a form of Cognitive Behavioral Therapy.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Rumination Responsiveness Scale (RRS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 5Eligibility criteria met

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.