Rumination-Focused Cognitive Behavioral Therapy for Depression

(RFCBT-I Trial)

Overseen By Patrick Possel, Dr.rer.soc.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Disqualifiers: None

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 28

Duration: 18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of Rumination-Focused Cognitive Behavioral Therapy (RFCBT) in reducing depression and improving heart health. It targets rumination, the habit of repeated negative thoughts that can harm mental and physical health. The trial specifically focuses on individuals with high blood pressure or symptoms of depression who also face financial challenges. Participants should frequently experience negative thoughts and be fluent in English. All participants will receive RFCBT to assess its impact on their well-being. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could enhance mental and physical health outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that Rumination-Focused Cognitive Behavioral Therapy is safe?

Studies have shown that Rumination-Focused Cognitive Behavioral Therapy (RFCBT) can reduce negative thinking patterns, known as rumination, often linked to depression. Research indicates that individuals who have tried RFCBT experienced significant decreases in both rumination and depression symptoms. Some early evidence suggests that RFCBT might also help with anxiety symptoms.

Importantly, no reports of serious side effects from RFCBT, a type of talk therapy, have emerged. This suggests it is generally safe. The therapy focuses on changing thought patterns rather than using medication, making it a low-risk option for addressing mental health issues like depression and anxiety without medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Rumination-Focused Cognitive Behavioral Therapy (RFCBT) is unique because it specifically targets rumination, a pattern of repetitive negative thinking often linked to depression. Unlike traditional CBT, which focuses broadly on changing negative thought patterns and behaviors, RFCBT zeroes in on reducing the tendency to overthink and dwell on problems. Researchers are excited about this approach because by directly addressing rumination, RFCBT has the potential to offer more rapid and sustained relief for individuals struggling with depression compared to standard treatments like medication or general CBT.

What evidence suggests that Rumination-Focused Cognitive Behavioral Therapy is effective for depression and heart health?

Research has shown that Rumination-Focused Cognitive Behavioral Therapy (RFCBT), which all participants in this trial will receive, can effectively reduce depression symptoms. In one study, 62% of patients who received RFCBT saw their depression symptoms disappear, compared to only 21% who received standard treatment. Another study found that RFCBT helped reduce rumination, where negative thoughts keep repeating, and also lowered the chances of depression and anxiety returning. This therapy might even help prevent depression symptoms from developing initially. Overall, RFCBT shows promise in helping people manage depression by focusing on reducing these repetitive negative thoughts. ^{3 6 7 8 9}

Who Is on the Research Team?

Patrick Possel, Dr.rer.soc.

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

This trial is for individuals who often have negative thoughts that loop continuously (rumination), are experiencing mild to moderate depression, and have high blood pressure. Participants must score at least 11 on the RSQ-Brooding scale, between 10-20 on the PHQ-9 depression scale, and have a systolic blood pressure of 120 or higher or diastolic blood pressure of 80 or higher. They also need to be fluent in English.

Inclusion Criteria

RSQ-Brooding score: >= 11

PHQ-9 score: 10-20

SBP: >= 120 and/or DBP: >= 80

Exclusion Criteria

None besides the described inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants undergo baseline data collection for 5 to 7 weeks before starting RFCBT

5-7 weeks

5-7 visits (in-person or virtual)

Treatment

Participants receive Rumination-Focused Cognitive Behavioral Therapy (RFCBT) in up to 18 sessions

18 weeks

18 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

5 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Rumination-Focused Cognitive Behavioral Therapy

Trial Overview

The study is testing Rumination-Focused Cognitive Behavioral Therapy (RFCBT) to see if it can reduce the risk of heart disease by targeting rumination—a factor linked to both depression and heart health—especially in low-income patients.

How Is the Trial Designed?

Group I: RFCBT Experimental Treatment 1 Intervention

This is a single subject design study. Thus, all participants receive Rumination-Focused Cognitive Behavior Therapy

Rumination-Focused Cognitive Behavioral Therapy is already approved in European Union, United States for the following indications:

Approved in European Union as RFCBT for:

• Depression
• Anxiety

Approved in United States as RFCBT for:

• Major Depressive Disorder
• Generalized Anxiety Disorder

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

Published Research Related to This Trial

In-session rumination, characterized by repetitive negative talk about depressive topics, was found to predict higher levels of clinician-rated depressive symptoms in patients undergoing cognitive behavioral therapy (CBT), based on a study of 63 treatment-naïve patients.

The intensity and duration of rumination during therapy sessions were significant indicators of depressive symptoms at the end of treatment, suggesting that addressing rumination could be beneficial for certain patients in CBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing in-session rumination and its effects on CBT for depression. Kennedy, JC., Dunlop, BW., Craighead, LW., et al.[2022]

A randomized controlled trial involving 251 high-risk young adults showed that both guided and group-delivered rumination-focused cognitive behavioral therapy (RFCBT) effectively reduced depressive symptoms and the onset of depression over one year compared to a no-intervention control.

The ongoing phase III trial in the UK aims to further test the efficacy of guided internet-RFCBT in preventing depression, with a focus on high-risk individuals aged 18 to 24, while also exploring the feasibility of an unguided self-help version to increase accessibility and reduce costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided, internet-based, rumination-focused cognitive behavioural therapy (i-RFCBT) versus a no-intervention control to prevent depression in high-ruminating young adults, along with an adjunct assessment of the feasibility of unguided i-RFCBT, in the REducing Stress and Preventing Depression trial (RESPOND): study protocol for a phase III randomised controlled trial. Cook, L., Watkins, E.[2019]

Guided Web-based Rumination-focused Cognitive Behavioral Therapy (i-RFCBT) significantly reduced the risk of developing major depression by 34% in high-risk university students over 15 months compared to usual care, particularly benefiting those with higher baseline stress levels.

The study also suggests that unguided i-RFCBT may be a feasible prevention strategy, as it showed similar effect sizes and compliance rates, indicating potential for scalability in preventing depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Stress and Preventing Depression (RESPOND): Randomized Controlled Trial of Web-Based Rumination-Focused Cognitive Behavioral Therapy for High-Ruminating University Students. Cook, L., Mostazir, M., Watkins, E.[2023]

Rumination is a key factor in the development and persistence of depression, and targeting this process can lead to effective treatments for chronic depression.

Two new interventions, rumination-focused cognitive therapy and concreteness training, have shown promising results in reducing depressive symptoms by addressing the specific cognitive styles associated with rumination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depressive rumination: investigating mechanisms to improve cognitive behavioural treatments. Watkins, ER.[2022]

In a study involving 76 youths with a history of depression, rumination-focused cognitive behavioral therapy (RF-CBT) significantly reduced self-reported rumination and altered brain connectivity, specifically between the left posterior cingulate cortex and right inferior frontal and inferior temporal gyri.

The results indicate that RF-CBT effectively modifies depressive rumination, a brain-based mechanism, suggesting that changes in brain connectivity may help reduce the frequency and intensity of ruminative thoughts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rumination-Focused Cognitive Behavioral Therapy Reduces Rumination and Targeted Cross-network Connectivity in Youth With a History of Depression: Replication in a Preregistered Randomized Clinical Trial. Langenecker, SA., Westlund Schreiner, M., Bessette, KL., et al.[2023]

Adolescents with remitted major depressive disorder (MDD) who underwent Rumination Focused Cognitive Behavioral Therapy (RF-CBT) showed increased brain activation in areas associated with rumination, indicating that RF-CBT may effectively alter brain function related to this habit.

The reliability of the rumination induction fMRI task was found to be fair to excellent in adolescents receiving treatment as usual (TAU), but poor in those who underwent RF-CBT, suggesting that RF-CBT may change how the brain responds to rumination tasks, which has implications for future research and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rumination Induction Task in fMRI: Test-Retest Reliability in Youth and Potential Mechanisms of Change with Intervention. Schreiner, MW., Miller, RH., Jacobsen, AM., et al.[2023]

A study involving 131 outpatients with major depression found that adding group rumination-focused cognitive-behavioral therapy (RFCBT) to routine medical management significantly improved depressive symptoms compared to standard group CBT, with a moderate effect size (Cohen's d 0.38).

While RFCBT showed immediate benefits in reducing depressive symptoms, there were no significant differences in rumination or depressive symptoms at the 6-month follow-up, suggesting that further research is needed to assess long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group rumination-focused cognitive-behavioural therapy (CBT) v. group CBT for depression: phase II trial. Hvenegaard, M., Moeller, SB., Poulsen, S., et al.[2020]

This study will compare the effectiveness of rumination-focused cognitive behavioral therapy (CBT) against standard CBT in treating depression, involving 128 patients in a randomized controlled trial.

By specifically targeting rumination, which is linked to the onset and persistence of depression, the trial aims to determine if this approach can reduce depressive symptoms and relapse rates more effectively than traditional CBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rumination-focused cognitive behaviour therapy vs. cognitive behaviour therapy for depression: study protocol for a randomised controlled superiority trial. Hvenegaard, M., Watkins, ER., Poulsen, S., et al.[2018]

Citations

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RFCBT was found to be superior to TAU; 62 % of patients in the RFCBT treatment condition achieved remission, compared with 21 % in the TAU [18].

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