Rumination-Focused Cognitive Behavioural Therapy for Depression

(RuMeChange Trial)

Recruiting at 2 trial locations

Overseen By Caty Escobar, M.S.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Must be taking: Antidepressants

Must not be taking: Mood stabilizers, Antipsychotics

Disqualifiers: Suicidality, Conduct disorder, Autism, others

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

Compensation: Varies

Number of Visits: 14

183 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new therapy called rumination-focused cognitive behavioral therapy (RF-CBT) to determine its effectiveness in reducing repetitive negative thinking and improving brain connections. Researchers aim to lower the risk of depression recurrence over the next two years. The trial compares RF-CBT with usual therapy and relaxation-based therapy. Teens previously diagnosed with major depressive disorder and currently in partial or full remission might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could shape future depression treatments.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that Rumination-Focused Cognitive Behavioral Therapy (RF-CBT) is generally easy for patients to handle. Research indicates that RF-CBT effectively reduces symptoms of depression and alters brain patterns related to overthinking. Reports of major side effects are absent, suggesting it is safe for most people.

Reviews suggest that relaxation-based therapy is also safe and effectively reduces depression symptoms. Patients have reported feeling better, and studies have noted no major negative effects.

Both treatments aim to manage depression with minimal risk, based on existing evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Rumination-Focused Cognitive Behavioral Therapy (RF-CBT) is unique because it specifically targets rumination, a common symptom in depression that involves repetitive, negative thinking. Unlike standard treatments like SSRIs or traditional CBT that focus broadly on mood and behavior, RF-CBT incorporates concreteness training and mindfulness to directly address these mental habits. Researchers are excited about RF-CBT because it offers a tailored approach that may prevent depression by transforming thought patterns and potentially enhancing long-term mental resilience.

What evidence suggests that Rumination-Focused CBT might be an effective treatment for depression?

Research has shown that Rumination-Focused Cognitive Behavioral Therapy (RF-CBT), a treatment in this trial, holds promise for treating depression. Studies have found that RF-CBT effectively reduces repetitive negative thinking and symptoms of depression. One study found that it helps prevent these symptoms from returning. Another study demonstrated that an online version of this therapy reduced anxiety and depression in adults. Overall, RF-CBT appears to be a strong option for reducing depression and its related habits. ^{1 2 6 7 8}

Who Is on the Research Team?

Scott Langenecker, Ph.D.

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Relaxation-based Therapy
• Rumination-Focused CBT

Trial Overview 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.

How Is the Trial Designed?

Group I: Rumination-Focused CBT Experimental Treatment 1 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 Usual Active Control 1 Intervention

Participants are allowed to continue any therapy outside of the treatment study.

Group III: Relaxation-based therapy Active Control 1 Intervention

RelaxT includes an active comparison treatment that can be used to monitor and modify physiological responses to stress

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Nationwide Children's Hospital

Collaborator

Trials

354

Recruited

5,228,000+

Utah Center for Evidence Based Treatment

Collaborator

Trials

1

Recruited

180+

University of Exeter

Collaborator

Trials

207

Recruited

1,368,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

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]

In a pilot study involving 33 adolescents with a history of Major Depressive Disorder, those receiving rumination-focused cognitive behavior therapy (RFCBT) showed a significant decrease in anxiety symptoms over the first six weeks of treatment.

RFCBT also led to increased behavioral activation compared to the assessment-only group, suggesting it may help improve engagement in activities, although global functioning did not show significant differences between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rumination-focused cognitive behavioral therapy decreases anxiety and increases behavioral activation among remitted adolescents. Feldhaus, CG., Jacobs, RH., Watkins, ER., et al.[2022]

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 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]

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]

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]

Citations

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