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Mindfulness Intervention to Study the Neurobiology of Depression (MIND)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01905267
Recruitment Status : Completed
First Posted : July 23, 2013
Results First Posted : July 30, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Rachel Jacobs, University of Illinois at Chicago

Brief Summary:
The Pediatric Mood Disorders Program at the University of Illinois at Chicago is conducting a research study examining how mindfulness can help teenagers stay healthy and prevent depression relapse.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Rumination-Focused Cognitive Behavior Therapy Not Applicable

Detailed Description:

Study involves:

  • Brain scan using fMRI technology
  • Questions about mood and behavior
  • Meeting with a clinician
  • Possibility of 8 weekly treatment sessions using mindfulness
  • Ongoing assessment of depression for next 2 years

Eligible participants will be compensated for their time.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mindfulness Intervention to Study the Neurobiology of Depression
Study Start Date : March 2013
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Participants randomized to the experimental condition will receive 8 weeks of individual treatment with Rumination-Focused Cognitive Behavior Therapy
Behavioral: Rumination-Focused Cognitive Behavior Therapy
This intervention targets rumination and other maladaptive forms of emotion regulation such as suppression and avoidance and provides skills training in effective coping strategies. Mindfulness is a key component of this intervention as a strategy for disengaging from one's thoughts. Strategies from Dialectical Behavior Therapy (DBT), such as the use of effective interpersonal skills, are also included as methods for regulating strong emotion. Rumination-Focused Cognitive Behavior Therapy is a structured, manual based program designed to be delivered weekly over eight weeks. Sessions are 60-90 minutes in length.

No Intervention: Control
Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study



Primary Outcome Measures :
  1. Change in Children's Depression Rating Scale - Revised [ Time Frame: Baseline, 8 week ]
    clinician measure completed with adolescent and parent Total scores reported. Range is between 17-119 Higher scores mean higher depressive symptoms


Secondary Outcome Measures :
  1. Change in Reynolds Adolescent Depression Scale [ Time Frame: Baseline, 8 week ]
    Self report adolescent depression total score. Range is 30-120 with higher scores meaning greater depressive symptoms.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • between the ages of 12 and 18
  • history of major depressive disorder

Exclusion Criteria:

  • braces
  • afraid of small spaces

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): NCT01905267


Locations
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United States, Illinois
University of Illinois at Chicago Pediatric Mood Disorders Program
Chicago, Illinois, United States, 60608
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
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Principal Investigator: Rachel H Jacobs, PhD University of Illinois at Chicago
  Study Documents (Full-Text)

Documents provided by Rachel Jacobs, University of Illinois at Chicago:
Informed Consent Form  [PDF] July 31, 2014
Study Protocol  [PDF] June 30, 2014
Statistical Analysis Plan  [PDF] July 1, 2014

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rachel Jacobs, Research Assistant Professor, Licensed Clinical Psychologist, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01905267    
Other Study ID Numbers: 2012-0689
First Posted: July 23, 2013    Key Record Dates
Results First Posted: July 30, 2018
Last Update Posted: July 30, 2018
Last Verified: October 2017
Keywords provided by Rachel Jacobs, University of Illinois at Chicago:
mindfulness
relapse prevention
recovery
depression
adolescents
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders