- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03859297
Mechanisms of Rumination Change in Adolescent Depression (RuMeChange)
Developing Rumination-focused Treatment to Reduce Risk for Depression Recurrence (RDR) in Adolescence
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Major Depressive Disorder (MDD) is a disease that has it's onset in childhood and early adolescence for many. Treatments in adolescence tend to be acute and short-term. Unfortunately, between half and three quarters of adolescents who have a first episode of MDD will go to have a second episode within the next two years. Studies in adults suggest that maintenance treatments or preventative treatments can lower these risks and delay or stop recurrences.
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.
- The Investigators determine if the child is eligible (see criteria below for 14-17 year olds with history of MDD.
The Investigators complete pre-intervention assessments with the child that include
- brain imaging
- tests of cognitive skills and emotion processing, including rumination
- questionnaires about how the adolescent thinks and responds to situations, similar questionnaires in at least one parent/guardian
- measurement of sleep using a handheld wristwatch (called an actigraph - optional).
- 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.
repeat assessments after the intervention period. The cognitive skills and emotion processing are also assessed during the middle of the intervention period.
- brain imaging
- tests of cognitive skills and emotion processing, including rumination
- questionnaires about how the adolescent thinks and responds to situations, similar questionnaires in at least one parent/guardian
- measurement of sleep using a handheld wristwatch (called an actigraph - optional).
follow-up assessments to determine any changes, recurrence of depression, new treatments for the next two years.
- questionnaires
- interviews
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Scott A Langenecker, Ph.D.
- Phone Number: 801-213-1200
- Email: s.langenecker@hsc.utah.edu
Study Contact Backup
- Name: Brian Farstead, B.A.
- Phone Number: 801-213-1087
- Email: brian.farstead@utah.edu
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84108
- Recruiting
- University of Utah
-
Contact:
- Scott A Langenecker, Ph.D.
- Phone Number: 801-213-1200
- Email: s.langenecker@hsc.utah.edu
-
Contact:
- Sheila E Crowell, Ph.D.
- Phone Number: 801-581-6124
- Email: sheila.crowell@psych.utah.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
- 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:
- Endorsement of suicidality with plan or intent (assessed via KSADSPL and Children's Depression Rating Scale (CDRS-R) clinical interviews. Current or past (within previous three months) plan or intent is exclusionary.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rumination-Focused CBT
RF-CBT is a manual-based treatment for prevention of depression, includes focus on ruminations, mental habits, concreteness training, and mindfulness.
|
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.
|
No Intervention: Treatment as Usual
Participants are allowed to continue any therapy outside of the treatment study.
|
|
Active Comparator: Relaxation-based therapy
RelaxT includes an active comparison treatment that can be used to monitor and modify physiological responses to stress
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rumination Responsiveness Scale (RRS)
Time Frame: ~14-22 weeks
|
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.
Time Frame: ~14-22 weeks
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB_00113733
- R61MH116080 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mood Disorders
-
Université du Québec a MontréalCiusss de L'Est de l'Île de Montréal; PhysioExtra; EnergirRecruitingDepression ; Anxiety With Depressed Mood ; Mood Disorder, Adjustment Disorder With Depressed MoodCanada
-
Joliet Center for Clinical ResearchAbbottCompleted
-
National Institute of Mental Health (NIMH)Completed
-
National Institute of Mental Health (NIMH)Completed
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Completed
-
University of Colorado, DenverCompletedMood Disorders | Irritable MoodUnited States
-
VA Office of Research and DevelopmentCompleted
-
Baskent UniversityZİYAFET UĞURLURecruitingDisaster; Personality | Disorder, MoodTurkey
-
Fayoum University HospitalCompletedKetamine-Induced Mood DisorderEgypt
-
Mayo ClinicCompletedMood Disorders in Children and AdolescentsUnited States
Clinical Trials on Rumination-Focused CBT
-
West University of TimisoaraUniversity of ExeterUnknownDepression | Generalized Anxiety Disorder | Panic Disorder | Social Phobia | Dysthymic DisorderRomania
-
VU University of AmsterdamZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedDepression | Anxiety DisordersNetherlands
-
University of CopenhagenUniversity of Exeter; The University of Western AustraliaCompletedDepression | Recurrent DepressionDenmark
-
University of Illinois at ChicagoCompleted
-
University of LouisvilleRecruitingBlood Pressure | Depressive Symptoms | RuminationUnited States
-
Mental Health Services in the Capital Region, DenmarkRecruiting
-
National Yang Ming UniversityBali Psychiatric CenterCompletedRandomized Controlled TrialTaiwan
-
University of ExeterCompletedRumination | Worry | Repetitive Negative ThinkingUnited Kingdom
-
University of ChicagoCompleted
-
Linnaeus UniversityKronoberg County Council; Capio GroupCompletedQuality of Life | Stress | Insomnia | Psychological Distress | Depression, Anxiety | Activities, Daily LivingSweden