Rumination-Focused Cognitive Behavioral Therapy for Depression
(RFCBT-I Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of Louisville
No Placebo Group
Approved in 2 Jurisdictions
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.
12345Is 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.
12678How 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.
12468Eligibility 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
+1 more
Exclusion Criteria
None besides the described inclusion criteria
Trial 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)
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: RFCBTExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Have a Heart clinicLouisville, KY
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Who Is Running the Clinical Trial?
University of LouisvilleLead Sponsor
References
Reducing Stress and Preventing Depression (RESPOND): Randomized Controlled Trial of Web-Based Rumination-Focused Cognitive Behavioral Therapy for High-Ruminating University Students. [2023]Prevention of depression is a priority to reduce its global disease burden. Targeting specific risk factors, such as rumination, may improve prevention. Rumination-focused Cognitive Behavioral Therapy (RFCBT) was developed to specifically target depressive rumination.
Rumination-focused cognitive behaviour therapy vs. cognitive behaviour therapy for depression: study protocol for a randomised controlled superiority trial. [2018]Cognitive behavioural therapy is an effective treatment for depression. However, one third of the patients do not respond satisfactorily, and relapse rates of around 30 % within the first post-treatment year were reported in a recent meta-analysis. In total, 30-50 % of remitted patients present with residual symptoms by the end of treatment. A common residual symptom is rumination, a process of recurrent negative thinking and dwelling on negative affect. Rumination has been demonstrated as a major factor in vulnerability to depression, predicting the onset, severity, and duration of future depression. Rumination-focused cognitive behavioural therapy is a psychotherapeutic treatment targeting rumination. Because rumination plays a major role in the initiation and maintenance of depression, targeting rumination with rumination-focused cognitive behavioural therapy may be more effective in treating depression and reducing relapse than standard cognitive behavioural therapy.
Group rumination-focused cognitive-behavioural therapy (CBT) v. group CBT for depression: phase II trial. [2020]Although cognitive-behavioural therapy (CBT) is an effective treatment for depression, less than half of patients achieve satisfactory symptom reduction during treatment. Targeting known psychopathological processes such as rumination may increase treatment efficacy. The aim of this study was to test whether adding group rumination-focused CBT (RFCBT) that explicitly targets rumination to routine medical management is superior to adding group CBT to routine medical management in treating major depression.
Depressive rumination: investigating mechanisms to improve cognitive behavioural treatments. [2022]Rumination has been identified as a core process in the development and maintenance of depression. Treatments targeting ruminative processes may, therefore, be particularly helpful for treating chronic and recurrent depression. The development of such treatments requires translational research that marries clinical trials, process-outcome research, and basic experimental research that investigates the mechanisms underpinning pathological rumination. For example, a program of experimental research has demonstrated that there are distinct processing modes during rumination that have distinct functional effects for the consequences of rumination on a range of clinically relevant cognitive and emotional processes: an adaptive style characterized by more concrete, specific processing and a maladaptive style characterized by abstract, overgeneral processing. Based on this experimental work, two new treatments for depression have been developed and evaluated: (a) rumination-focused cognitive therapy, an individual-based face-to-face therapy, which has encouraging results in the treatment of residual depression in an extended case series and a pilot randomized controlled trial; and (b) concreteness training, a facilitated self-help intervention intended to increase specificity of processing in patients with depression, which has beneficial findings in a proof-of-principle study in a dysphoric population. These findings indicate the potential value of process-outcome research (a) explicitly targeting identified vulnerability processes and (b) developing interventions informed by research into basic mechanisms.
Assessing in-session rumination and its effects on CBT for depression. [2022]The study evaluated if rumination of patients during therapy (i.e., in-session rumination) relates to whether or not they do less well in CBT treatment. We developed a reliably assessed in-session rumination observational measure and evaluated its relationship to depression over the course of CBT. Rated sessions came from 63 treatment-naïve patients with major depressive disorder who participated in CBT in the PReDICT study (Dunlop et al., 2017). In-session rumination was operationalized as repetitive, negative, and passive talking about depressive topics. Trained undergraduates rated the intensity and duration of in-session rumination occurring during 57 initial therapy sessions (i.e., session one) and 45 sessions in the middle of treatment (i.e., session eight). The observational ratings were sufficiently reliable (all ICCs > 0.69). Mixed model results indicated that greater intensity of in-session rumination during the initial treatment session predicted higher levels of subsequent clinician-rated depressive symptoms (p
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]Rumination-focused cognitive behavioral therapy (RF-CBT) is designed to reduce depressive rumination or the habitual tendency to dwell on experiences in a repetitive, negative, passive, and global manner. RF-CBT uses functional analysis, experiential exercises, and repeated practice to identify and change the ruminative habit. This preregistered randomized clinical trial (NCT03859297, R61) is a preregistered replication of initial work. We hypothesized a concurrent reduction of both self-reported rumination and cross-network connectivity between the left posterior cingulate cortex and right inferior frontal and inferior temporal gyri.
Rumination Induction Task in fMRI: Test-Retest Reliability in Youth and Potential Mechanisms of Change with Intervention. [2023]Rumination is a transdiagnostic problem that is common in major depressive disorder (MDD). Rumination Focused Cognitive Behavioral Therapy (RF-CBT) explicitly targets the ruminative habit. This study examined changes in brain activation during a rumination induction task in adolescents with remitted MDD following RF-CBT. We also evaluated the reliability of the rumination task among adolescents who received treatment as usual (TAU).
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]Depression is a global health challenge. Prevention is highlighted as a priority to reduce its prevalence. Although effective preventive interventions exist, the efficacy and coverage can be improved. One proposed means to increase efficacy is by using interventions to target specific risk factors, such as rumination. Rumination-focused CBT (RFCBT) was developed to specifically target depressive rumination and reduces acute depressive symptoms and relapse for patients with residual depression in a randomised controlled trial. Preliminary findings from a Dutch randomised prevention trial in 251 high-risk 15- to 22-year-old subjects selected with elevated worry and rumination found that both supported internet-RFBCT and group-delivered RFCBT equally reduced depressive symptoms and the onset of depressive cases over a period of 1 year, relative to the no-intervention control.