Rumination-Focused Cognitive Behavioural Therapy for Depression
(RuMeChange Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byScott Langenecker, Ph.D.
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ohio State University
Must be taking: Antidepressants
Must not be taking: Mood stabilizers, Antipsychotics
Disqualifiers: Suicidality, Conduct disorder, Autism, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
You can continue taking your current antidepressant medication if it has been stable for at least four weeks without any dose changes and no changes in the specific medication for six weeks. However, other psychotropic medications like mood stabilizers and antipsychotics are not allowed.
What data supports the effectiveness of the treatment Rumination-Focused Cognitive Behavioural Therapy for Depression?
Rumination-Focused Cognitive Behavioural Therapy (RFCBT) specifically targets rumination, a key factor in depression, and has shown promise in reducing depressive symptoms and preventing relapse. Studies suggest that RFCBT may be more effective than standard cognitive behavioural therapy by focusing on this specific risk factor, potentially leading to better outcomes for patients with depression.12345
Is Rumination-Focused Cognitive Behavioral Therapy (RFCBT) safe for humans?
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.12347
Eligibility Criteria
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.Inclusion Criteria
I am between 14 and 17 years old.
Youth assent and parent consent.
I was diagnosed with Major Depressive Disorder but have been in remission for at least two weeks.
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Exclusion Criteria
I am currently in or have recently had a form of Cognitive Behavioral Therapy.
You have had certain mental health conditions like conduct disorder, autism, psychotic disorder, or bipolar disorder at any point in your life. Additionally, if you have had an eating disorder or alcohol/substance abuse within the past 6 months, you will not be able to participate. However, having anxiety disorder, disruptive mood dysregulation disorder, oppositional defiant disorder, or Attention Deficit Hyperactivity Disorder (ADHD) in the past will not exclude you from participating.
I am only taking antidepressants with no dose changes in 4 weeks.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Pre-intervention Assessment
Pre-intervention assessments including brain imaging, cognitive skills tests, and questionnaires
2-4 weeks
2 visits (in-person)
Treatment (Years 1-2)
Randomization to RF-CBT or assessment only for a 10-14 session intervention
14-22 weeks
10-14 sessions (in-person)
Mid-intervention Assessment
Cognitive skills and emotion processing assessments during the middle of the intervention
2 weeks
1 visit (in-person)
Treatment (Years 3-5)
Randomization to RF-CBT or Relaxation Therapy above and beyond Treatment as Usual
3 years
Follow-up
Follow-up assessments to determine any changes, recurrence of depression, new treatments for the next two years
2 years
Regular follow-up visits
Treatment Details
Interventions
- Relaxation-based Therapy (Relaxation Therapy)
- Rumination-Focused CBT (Cognitive Behavioral Therapy)
Trial OverviewThe 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.
Participant Groups
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Nationwide Children's HospitalColumbus, OH
The Ohio State UniversityColumbus, OH
University of UtahSalt Lake City, UT
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Who Is Running the Clinical Trial?
Ohio State UniversityLead Sponsor
Nationwide Children's HospitalCollaborator
Utah Center for Evidence Based TreatmentCollaborator
University of ExeterCollaborator
National Institute of Mental Health (NIMH)Collaborator
University of UtahCollaborator
References
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.
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.
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.
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.
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.
Rumination-focused cognitive behavioral therapy decreases anxiety and increases behavioral activation among remitted adolescents. [2022]Rumination involves a repetitive, passive focus on one's thoughts and feelings and has been hypothesized as a mechanism contributing to multiple psychopathologies. The current investigation explores secondary outcomes from a pilot study to examine whether rumination-focused cognitive behavior therapy (RFCBT) alleviates symptoms of anxiety, increases behavioral activation, or increases global functioning among adolescents with a history of Major Depressive Disorder (MDD).
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.