Rumination-Focused Cognitive Behavioural Therapy for Depression

(RuMeChange Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Scott 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. ^{1 2 3 4 5}

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

The research on Rumination-Focused Cognitive Behavioral Therapy (RFCBT) does not report any specific safety concerns, suggesting it is generally safe for humans. It has been used in studies with young adults and adolescents without noted adverse effects. ^{1 2 4 6 7}

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 3 4 7}

Research Team

Scott Langenecker, Ph.D.

Principal Investigator

Ohio State University

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.

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.

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 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.

Participant Groups

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+

Dr. John J. Warner

Ohio State University

Chief Executive Officer since 2023

MD, MBA

Dr. Peter Mohler

Ohio State University

Chief Medical Officer since 2023

PhD in Molecular Biology

Nationwide Children's Hospital

Collaborator

Trials

354

Recruited

5,228,000+

Catherine Krawczeski

Nationwide Children's Hospital

Chief Medical Officer

MD

Timothy C. Robinson

Nationwide Children's Hospital

Chief Executive Officer since 2019

BSc in Psychology and Business Administration from Indiana University

Utah Center for Evidence Based Treatment

Collaborator

Trials

1

Recruited

180+

University of Exeter

Collaborator

Trials

207

Recruited

1,368,000+

Professor Neil Gow

University of Exeter

Chief Executive Officer since 2018

PhD in Microbiology from the University of Aberdeen

Professor Inês Barroso

University of Exeter

Chief Medical Officer since 2020

PhD in Human Molecular Genetics from the University of Cambridge

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Jeffrey Wilkins

University of Utah

Chief Medical Officer since 2022

MD from Meharry Medical College

Stephen Tullman

University of Utah

Chief Executive Officer since 2022

BS in Accounting from Rutgers University

Findings from Research

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]

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]

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]

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 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]

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]

References

1. 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]

2. 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]

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

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]

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

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

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

Rumination-focused cognitive behavioral therapy decreases anxiety and increases behavioral activation among remitted adolescents. [2022]

7. 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]