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Trial record 7 of 27 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Utah, United States ) | NIH, U.S. Fed

Mechanisms of Rumination Change in Adolescent Depression (RuMeChange)

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ClinicalTrials.gov Identifier: NCT03859297
Recruitment Status : Not yet recruiting
First Posted : March 1, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborators:
University of Exeter
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Scott Langenecker, University of Utah

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Mood Disorders Behavioral: Rumination-Focused CBT Behavioral: Relaxation-based Therapy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 183 participants
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
Official Title: Developing Rumination-focused Treatment to Reduce Risk for Depression Recurrence (RDR) in Adolescence
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine


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.
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.

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
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.




Primary Outcome Measures :
  1. 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.


  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   all gender representations are allowed.
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859297


Contacts
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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

Locations
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United States, Utah
University of Utah Active, not recruiting
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
University of Exeter
National Institute of Mental Health (NIMH)

Publications of Results:
Other Publications:
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Responsible Party: Scott Langenecker, Professor, University of Utah
ClinicalTrials.gov Identifier: NCT03859297     History of Changes
Other Study ID Numbers: IRB_00113733
R61MH116080 ( U.S. NIH Grant/Contract )
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Scott Langenecker, University of Utah:
rumination
depression
brain imaging
cognitive behavioral therapy
rumination focused cognitive behavioral therapy
default mode network
rumination induction

Additional relevant MeSH terms:
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Disease
Depression
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Pathologic Processes
Behavioral Symptoms
Mental Disorders