Mindfulness Intervention to Study the Neurobiology of Depression

NCT ID: NCT01905267

Last Updated: 2018-07-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment

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

Group Type EXPERIMENTAL

Rumination-Focused Cognitive Behavior Therapy

Intervention Type BEHAVIORAL

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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* braces
* afraid of small spaces
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Rachel Jacobs

Research Assistant Professor, Licensed Clinical Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rachel H Jacobs, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

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University of Illinois at Chicago Pediatric Mood Disorders Program

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32555582 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27880789 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2012-0689

Identifier Type: -

Identifier Source: org_study_id

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