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

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

9 Participants Needed

Trial Summary

What is the purpose of this trial?

Many people know that a poor diet, exercise, smoking, and alcohol use cause heart disease. However, a less known factor that increases the risk of heart disease is depression. In addition, heart disease can also make depression worse. Almost half of American adults have some form of heart disease. Patients with low income are at an even greater risk. The circular relation between depression and heart disease raises the question of whether or not there are factors that lead to both. Attacking a factor that affects both depression and heart disease could help prevent them both. One such factor is rumination which is when someone tends to have repeated negative thoughts that loop without end. This loop in turn tears and wears down the body over time, making the person be at risk for heart disease and depression. Rumination-Focused Cognitive Behavioral Therapy (RFCBT) is a tool that targets rumination and, by doing so, reduces the risk for depression. While research has shown RFCBT helps to reduce or stop the loop that leads to depression, this project will further look at the effect of RFCBT on measures of heart health persons with low income.

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 data supports the effectiveness of the treatment Rumination-Focused Cognitive Behavioral Therapy (RFCBT) for depression?

Research shows that targeting rumination, a pattern of repetitive negative thinking, with Rumination-Focused Cognitive Behavioral Therapy (RFCBT) can be more effective in treating depression and reducing relapse compared to standard cognitive behavioral therapy. Studies indicate that RFCBT specifically helps by addressing rumination, which is a major factor in the onset and maintenance of depression. ^{1 2 3 4 5}

Is Rumination-Focused Cognitive Behavioral Therapy (RFCBT) safe for humans?

The research does not report any specific safety concerns for Rumination-Focused Cognitive Behavioral Therapy (RFCBT), suggesting it is generally safe for humans. ^{1 2 6 7 8}

How is Rumination-Focused Cognitive Behavioral Therapy different from other treatments for depression?

Rumination-Focused Cognitive Behavioral Therapy (RFCBT) is unique because it specifically targets rumination, which is the habit of dwelling on negative thoughts, a major factor in depression. By focusing on changing this ruminative habit, RFCBT may be more effective in reducing depression symptoms and preventing relapse compared to standard cognitive behavioral therapy. ^{1 2 4 6 8}

Research Team

Patrick Possel, Dr.rer.soc.

Principal Investigator

University of Louisville

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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-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]

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 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]

References

1. Canada 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Rumination-focused cognitive behaviour therapy vs. cognitive behaviour therapy for depression: study protocol for a randomised controlled superiority trial. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Group rumination-focused cognitive-behavioural therapy (CBT) v. group CBT for depression: phase II trial. [2020]

4. England pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Assessing in-session rumination and its effects on CBT for depression. [2022]

6. United States 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Rumination Induction Task in fMRI: Test-Retest Reliability in Youth and Potential Mechanisms of Change with Intervention. [2023]

8. England 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. [2019]