Mindfulness Intervention to Study the Neurobiology of Depression (MIND)

• 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: University of Illinois at Chicago
• Information provided by (Responsible Party): Rachel Jacobs, University of Illinois at Chicago

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• 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
• 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:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders