Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mechanisms of Rumination Change in Adolescent Depression (RuMeChange)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859297
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborators:
University of Exeter
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Scott Langenecker, University of Utah

Tracking Information
First Submitted Date  ICMJE February 27, 2019
First Posted Date  ICMJE March 1, 2019
Last Update Posted Date November 12, 2019
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2019)
  • Rumination Responsiveness Scale (RRS) [ Time Frame: 10 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.
  • Resting state functional magnetic resonance imaging (fMRI) connectivity of Default mode network to cognitive control network. [ Time Frame: 10 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
  • Rumination Responsiveness Scale (RRS) [ Time Frame: 10 weeks ]
    RRS is a scale developed by Dr. Susan Nolan-Hoeksema that is used to determine pre-post reductions in rumination after RF-CBT
  • Resting state functional magnetic resonance imaging (fMRI) connectivity of Default mode network to cognitive control network. [ Time Frame: 10 weeks ]
    Using seed based approaches with the posterior cingulate gyrus and medial prefrontal cortex, we 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mechanisms of Rumination Change in Adolescent Depression
Official Title  ICMJE Developing Rumination-focused Treatment to Reduce Risk for Depression Recurrence (RDR) in Adolescence
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.
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.

  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-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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

First two years. randomization to either rumination-focused cognitive behavioral therapy (RF-CBT) or Assessment only (AO) for a 10 week intervention period.

Last three years. randomization to either rumination-focused cognitive behavioral therapy (RF-CBT) or Relaxation therapy (RelaxT) for a 10 week intervention period.

Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Major Depressive Disorder
  • Mood Disorders
Intervention  ICMJE
  • Behavioral: 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.
  • Behavioral: 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Rumination-Focused CBT
  • 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
    Intervention: Behavioral: Relaxation-based Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 27, 2019)
183
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2026
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: all gender representations are allowed.
Ages  ICMJE 14 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Scott A Langenecker, Ph.D. 801-213-1200 s.langenecker@hsc.utah.edu
Contact: Stephanie L Pocius, B.A. 801-213-1087 u6021315@utah.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03859297
Other Study ID Numbers  ICMJE IRB_00113733
R61MH116080 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (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.
Responsible Party Scott Langenecker, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE
  • University of Exeter
  • National Institute of Mental Health (NIMH)
Investigators  ICMJE Not Provided
PRS Account University of Utah
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP