NCT01905267

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 30, 2018

Completed
Last Updated

July 30, 2018

Status Verified

October 1, 2017

Enrollment Period

4.3 years

First QC Date

July 10, 2013

Results QC Date

August 3, 2017

Last Update Submit

October 25, 2017

Conditions

Depression

Keywords

mindfulnessrelapse preventionrecoverydepressionadolescents

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline, 8 week

Secondary Outcomes (1)

  • Change in Reynolds Adolescent Depression Scale

    Baseline, 8 week

Study Arms (2)

Treatment

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Rumination-Focused Cognitive Behavior TherapyBEHAVIORAL

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.

Treatment

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • braces
  • afraid of small spaces

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago Pediatric Mood Disorders Program

Chicago, Illinois, 60608, United States

Location

Related Publications (2)

  • 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.

    PMID: 32555582DERIVED

  • 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.

    PMID: 27880789DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Limitations and Caveats

Small number of subjects

Results Point of Contact

Title
Rachel Jacobs
Organization
University of Illinois at Chicago
rjacobs@psych.uic.edu
3124139178

Study Officials

  • Rachel H Jacobs, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor, Licensed Clinical Psychologist

Study Record Dates

First Submitted

July 10, 2013

First Posted

July 23, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 30, 2018

Results First Posted

July 30, 2018

Record last verified: 2017-10

Locations

US(1)