Mechanisms of Rumination Change in Adolescent Depression
RuMeChange
Developing Rumination-focused Treatment to Reduce Risk for Depression Recurrence (RDR) in Adolescence
2 other identifiers
interventional
183
1 country
3
Brief Summary
This study will evaluate whether a newer treatment, rumination-focused cognitive behavioral treatment, which includes mindfulness and can be used to reduce ruminative habits, change ways in which key brain regions interact with each other (e.g.., often called connectivity), and whether these changes in habits and brain connectivity can reduce the risk for recurrence of depression in the next two years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable major-depressive-disorder
Started May 2019
Longer than P75 for not_applicable major-depressive-disorder
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2019
CompletedFirst Posted
Study publicly available on registry
March 1, 2019
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 2, 2029
August 11, 2025
August 1, 2025
9 years
February 27, 2019
August 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rumination Responsiveness Scale (RRS)
RRS is a scale developed by Dr. Susan Nolan-Hoeksema that is used to determine pre-post reductions in rumination after RF-CBT. The RRS is the Rumination Responsiveness Scale. Scores range from a low of 22 to a high of 88 on the 232 item scale. Higher scores indicate more difficulties with rumination. Higher rumination has been reported in a number of samples of both active and remitted MDD. The outcome is a reliable change index decline of at least 1/2 standard deviation in the RF-CBT group relative to the AO and RelaxT arms. In our preliminary study, the RRS declined from 52.88 to 43 (Jacobs et al., 2016). An age matched control group had a mean score of 30.4 (7.1), Burkhouse et al., 2016.
~14-22 weeks
Resting state functional magnetic resonance imaging (fMRI) connectivity of Default mode network to cognitive control network.
Using seed based approaches with the posterior cingulate gyrus and medial prefrontal cortex, the investigators will evaluate if RF-CBT and not AO or RelaxT, results in decreases in rs-fMRI connectivity to cognitive control network nodes, particularly right inferior frontal and temporal gyri.
~14-22 weeks
Study Arms (3)
Rumination-Focused CBT
EXPERIMENTALRF-CBT is a manual-based treatment for prevention of depression, includes focus on ruminations, mental habits, concreteness training, and mindfulness.
Treatment as Usual
NO INTERVENTIONParticipants are allowed to continue any therapy outside of the treatment study.
Relaxation-based therapy
ACTIVE COMPARATORRelaxT includes an active comparison treatment that can be used to monitor and modify physiological responses to stress
Interventions
RF-CBT targets rumination and other maladaptive forms of emotion regulation such as suppression and avoidance and provides skills training in effectively coping with rumination. RF-CBT specifically targets rumination through psychoeducation, adopting a functional analytic approach to the learned habitual behavior of rumination, and a focus on shifting process style. The adolescent is taught to notice triggers to ruminate as well as the consequences of rumination and to shift into practicing a more adaptive strategy such as an attention training exercise, behavioral activation, thinking in a concrete way, or active problem-solving. RF-CBT directly teaches adolescents to recognize rumination or "when the participant gets stuck in their head" and to notice the influence this has on their mood.
Sessions will include progressive muscle relaxation, simple breathing techniques, and guided imagery that focus on bodily and somatic relaxation. Adolescents randomized to Relaxation Therapy (RelaxT) will also receive exercises to do as homework in between sessions, parallel to the RF-CBT group.
Eligibility Criteria
You may qualify if:
- Previous diagnosis of Major Depressive Disorder (full or partial remission for at least two weeks) according to Diagnostic and Statistical Manual (DSM-V) criteria confirmed by the Kiddie Schedule for affective disorders (KSADSPL). Partial remission is defined as not meeting full DSM-V criteria for MDD.
- RRS score above the age and sex specific mean, T \> 50).
- years of age at enrollment (accounting for 2 year follow-up),
- Postpubertal (Petersen Pubertal Developmental Scale)
- Youth assent and parent consent
- Intellectual Quotient (IQ) \> 75, determined by Wechsler Abbreviated Scale of Intelligence (WASI)
You may not qualify if:
- Current treatment with RF-CBT, Cognitive Behavioral Therapy (CBT), or variants thereof, or in the last 2 years. Likewise, detail oriented therapy beyond supportive therapy (e.g., homework, cognitive restructuring), in same time window (ability to recall elements of structured therapies with CBT focus).
- Metal braces or retainers, tattoos with metal, or clothing with metal fibers.
- Claustrophobia
- Current pregnancy - Parents will be asked this information at the phone screen. At the clinic eligibility visit, female participants will be asked about sexual activity in a private room separate from their parents using the pregnancy script/screen that the investigators have created. This script details that if a female is ineligible due to pregnancy or inadequate birth control, this information will not be disclosed to her parent(s). Participants who are sexually active will be asked about birth control method. Abstinence will be considered an approved form of contraception.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ohio State Universitylead
- University of Exetercollaborator
- National Institute of Mental Health (NIMH)collaborator
- University of Utahcollaborator
- Nationwide Children's Hospitalcollaborator
- Utah Center for Evidence Based Treatmentcollaborator
Study Sites (3)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
The Ohio State University
Columbus, Ohio, 43210, United States
University of Utah
Salt Lake City, Utah, 84108, United States
Related Publications (8)
Watkins ER, Mullan E, Wingrove J, Rimes K, Steiner H, Bathurst N, Eastman R, Scott J. Rumination-focused cognitive-behavioural therapy for residual depression: phase II randomised controlled trial. Br J Psychiatry. 2011 Oct;199(4):317-22. doi: 10.1192/bjp.bp.110.090282. Epub 2011 Jul 21.
PMID: 21778171BACKGROUNDBurkhouse KL, Jacobs RH, Peters AT, Ajilore O, Watkins ER, Langenecker SA. Neural correlates of rumination in adolescents with remitted major depressive disorder and healthy controls. Cogn Affect Behav Neurosci. 2017 Apr;17(2):394-405. doi: 10.3758/s13415-016-0486-4.
PMID: 27921216BACKGROUNDJacobs RH, Watkins ER, Peters AT, Feldhaus CG, Barba A, Carbray J, Langenecker SA. Targeting Ruminative Thinking in Adolescents at Risk for Depressive Relapse: Rumination-Focused Cognitive Behavior Therapy in a Pilot Randomized Controlled Trial with Resting State fMRI. PLoS One. 2016 Nov 23;11(11):e0163952. doi: 10.1371/journal.pone.0163952. eCollection 2016.
PMID: 27880789BACKGROUNDHvenegaard M, Watkins ER, Poulsen S, Rosenberg NK, Gondan M, Grafton B, Austin SF, Howard H, Moeller SB. Rumination-focused cognitive behaviour therapy vs. cognitive behaviour therapy for depression: study protocol for a randomised controlled superiority trial. Trials. 2015 Aug 11;16:344. doi: 10.1186/s13063-015-0875-y.
PMID: 26260780BACKGROUNDWatkins ER, Nolen-Hoeksema S. A habit-goal framework of depressive rumination. J Abnorm Psychol. 2014 Feb;123(1):24-34. doi: 10.1037/a0035540.
PMID: 24661156BACKGROUNDMcEvoy PM, Watson H, Watkins ER, Nathan P. The relationship between worry, rumination, and comorbidity: evidence for repetitive negative thinking as a transdiagnostic construct. J Affect Disord. 2013 Oct;151(1):313-20. doi: 10.1016/j.jad.2013.06.014. Epub 2013 Jul 16.
PMID: 23866301BACKGROUNDDillahunt AK, Feldman DA, Thomas LR, Farstead BW, Frandsen SB, Lee S, Pazdera M, Galloway J, Bessette KL, Roberts H, Crowell SE, Watkins ER, Langenecker SA, Westlund Schreiner M. Self-Injury in Adolescence Is Associated with Greater Behavioral Risk Avoidance, Not Risk-Taking. J Clin Med. 2022 Feb 26;11(5):1288. doi: 10.3390/jcm11051288.
PMID: 35268378BACKGROUNDRoberts H, Jacobs RH, Bessette KL, Crowell SE, Westlund-Schreiner M, Thomas L, Easter RE, Pocius SL, Dillahunt A, Frandsen S, Schubert B, Farstead B, Kerig P, Welsh RC, Jago D, Langenecker SA, Watkins ER. Mechanisms of rumination change in adolescent depression (RuMeChange): study protocol for a randomised controlled trial of rumination-focused cognitive behavioural therapy to reduce ruminative habit and risk of depressive relapse in high-ruminating adolescents. BMC Psychiatry. 2021 Apr 23;21(1):206. doi: 10.1186/s12888-021-03193-3.
PMID: 33892684DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Langenecker, Ph.D.
Ohio State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 27, 2019
First Posted
March 1, 2019
Study Start
May 1, 2019
Primary Completion (Estimated)
April 14, 2028
Study Completion (Estimated)
March 2, 2029
Last Updated
August 11, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be shared in line with Resource Sharing guidelines for this specific RFA
- Access Criteria
- Available to researchers, after appropriate data sharing agreements have been made with the University of Utah.
All de-identified data relevant to the clinical trial and primary R61/R33 targets will be release biannually per requirements of the NIH policy, the request for application (RFA) and consistent with HIPAA and Institutional Review Board (IRB) approval at the University of Utah and the University of Exeter. In addition to the data for the clinical trial specifically, demographic and clinical information will be included.