Mindfulness Intervention to Study the Neurobiology of Depression (MIND)

October 25, 2017 updated by: Rachel Jacobs, University of Illinois at Chicago
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60608
        • University of Illinois at Chicago Pediatric Mood Disorders Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • braces
  • afraid of small spaces

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 8 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Investigators

  • Principal Investigator: Rachel H Jacobs, PhD, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

July 10, 2013

First Submitted That Met QC Criteria

July 18, 2013

First Posted (Estimate)

July 23, 2013

Study Record Updates

Last Update Posted (Actual)

July 30, 2018

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-0689

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.

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