Mechanisms of Rumination Change in Adolescent Depression
NCT ID: NCT03859297
Last Updated: 2025-08-11
Study Results
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Basic Information
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RECRUITING
NA
183 participants
INTERVENTIONAL
2019-05-01
2029-03-02
Brief Summary
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Detailed Description
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The present study will use a preventative strategy, rumination-focused CBT (RF-CBT) to delay or stop the onset of another MD episode for at least two years.
For the first 2 years of the study, adolescents with a history of MDD who are currently well will be randomly selected for either treatment with RF-CBT or just treatment as usual in the first two years of the study.
In the last 3 years of the study, these adolescents will be randomized to either RF-CBT or Relaxation Therapy above and beyond TAU (Treatment as Usual). Brain, cognitive, and self-report measurements are collected before during and after the intervention to evaluate what brain and rumination changes occur, and which adolescents benefit the most from the treatment.
What will happen.
1. The Investigators determine if the child is eligible (see criteria below for 14-17 year olds with history of MDD.
2. The Investigators complete pre-intervention assessments with the child that include
1. brain imaging
2. tests of cognitive skills and emotion processing, including rumination
3. questionnaires about how the adolescent thinks and responds to situations, similar questionnaires in at least one parent/guardian
4. measurement of sleep using a handheld wristwatch (called an actigraph - optional).
3. randomization (chance assignment) in years 1-2 to either rumination focused cognitive behavioral therapy (RF-CBT) or assessment only for a 10-14 session intervention. Treatment as usual continues for all adolescents. In years 3-5, chance assignment is to RF-CBT or Relaxation Therapy.
4. repeat assessments after the intervention period. The cognitive skills and emotion processing are also assessed during the middle of the intervention period.
1. brain imaging
2. tests of cognitive skills and emotion processing, including rumination
3. questionnaires about how the adolescent thinks and responds to situations, similar questionnaires in at least one parent/guardian
4. measurement of sleep using a handheld wristwatch (called an actigraph - optional).
5. follow-up assessments to determine any changes, recurrence of depression, new treatments for the next two years.
1. questionnaires
2. interviews
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Last three years. randomization to either rumination-focused cognitive behavioral therapy (RF-CBT) or Relaxation therapy (RelaxT) for a 10 week intervention period.
PREVENTION
DOUBLE
Study Groups
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Rumination-Focused CBT
RF-CBT is a manual-based treatment for prevention of depression, includes focus on ruminations, mental habits, concreteness training, and mindfulness.
Rumination-Focused CBT
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.
Treatment as Usual
Participants are allowed to continue any therapy outside of the treatment study.
No interventions assigned to this group
Relaxation-based therapy
RelaxT includes an active comparison treatment that can be used to monitor and modify physiological responses to stress
Relaxation-based Therapy
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.
Interventions
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Rumination-Focused CBT
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.
Relaxation-based Therapy
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
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Inclusion Criteria
* RRS score above the age and sex specific mean, T \> 50).
* 14-17 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)
Exclusion Criteria
* Lifetime history of conduct disorder, autism, any psychotic disorder (or episode unexplained by other known medical causes), or bipolar disorder. Eating disorder or alcohol/substance abuse within the previous 6 months. (Lifetime history of an anxiety disorder, disruptive mood dysregulation disorder or oppositional defiant disorder, Attention Deficit Hyperactivity Disorder (ADHD) will not be exclusionary).
* 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.
* Psychotropic medication outside of antidepressants such as mood stabilizers and antipsychotics will be exclusionary. Participants may have a history of current, stable antidepressant medication use, with no changes in dose for the past four weeks, no change in specific medication for six weeks.
14 Years
17 Years
ALL
No
Sponsors
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University of Exeter
OTHER
National Institute of Mental Health (NIMH)
NIH
University of Utah
OTHER
Nationwide Children's Hospital
OTHER
Utah Center for Evidence Based Treatment
UNKNOWN
Ohio State University
OTHER
Responsible Party
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Scott Langenecker
Professor
Principal Investigators
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Scott Langenecker, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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Nationwide Children's Hospital
Columbus, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Burkhouse 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.
Jacobs 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.
Hvenegaard 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.
Watkins ER, Nolen-Hoeksema S. A habit-goal framework of depressive rumination. J Abnorm Psychol. 2014 Feb;123(1):24-34. doi: 10.1037/a0035540.
McEvoy 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.
Dillahunt 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.
Roberts 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.
Other Identifiers
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IRB_00113733
Identifier Type: -
Identifier Source: org_study_id
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