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Mindfulness Intervention to Study the Neurobiology of Depression (MIND)

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rumination-Focused Cognitive Behavior Therapy
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring mindfulness, relapse prevention, recovery, depression, adolescents

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • braces
  • afraid of small spaces

Sites / Locations

  • University of Illinois at Chicago Pediatric Mood Disorders Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

Participants randomized to the experimental condition will receive 8 weeks of individual treatment with Rumination-Focused Cognitive Behavior Therapy

Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study

Outcomes

Primary Outcome Measures

Change in Children's Depression Rating Scale - Revised
clinician measure completed with adolescent and parent Total scores reported. Range is between 17-119 Higher scores mean higher depressive symptoms

Secondary Outcome Measures

Change in Reynolds Adolescent Depression Scale
Self report adolescent depression total score. Range is 30-120 with higher scores meaning greater depressive symptoms.

Full Information

First Posted
July 10, 2013
Last Updated
October 25, 2017
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01905267
Brief Title
Mindfulness Intervention to Study the Neurobiology of Depression
Acronym
MIND
Official Title
Mindfulness Intervention to Study the Neurobiology of Depression
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
mindfulness, relapse prevention, recovery, depression, adolescents

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Participants randomized to the experimental condition will receive 8 weeks of individual treatment with Rumination-Focused Cognitive Behavior Therapy
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study
Intervention Type
Behavioral
Intervention Name(s)
Rumination-Focused Cognitive Behavior Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Children's Depression Rating Scale - Revised
Description
clinician measure completed with adolescent and parent Total scores reported. Range is between 17-119 Higher scores mean higher depressive symptoms
Time Frame
Baseline, 8 week
Secondary Outcome Measure Information:
Title
Change in Reynolds Adolescent Depression Scale
Description
Self report adolescent depression total score. Range is 30-120 with higher scores meaning greater depressive symptoms.
Time Frame
Baseline, 8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: between the ages of 12 and 18 history of major depressive disorder Exclusion Criteria: braces afraid of small spaces
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel H Jacobs, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago Pediatric Mood Disorders Program
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32555582
Citation
Bessette KL, Jacobs RH, Heleniak C, Peters AT, Welsh RC, Watkins ER, Langenecker SA. Malleability of rumination: An exploratory model of CBT-based plasticity and long-term reduced risk for depressive relapse among youth from a pilot randomized clinical trial. PLoS One. 2020 Jun 17;15(6):e0233539. doi: 10.1371/journal.pone.0233539. eCollection 2020.
Results Reference
derived
PubMed Identifier
27880789
Citation
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.
Results Reference
derived

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Mindfulness Intervention to Study the Neurobiology of Depression

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