MIND: Mindfulness Intervention to Study the Neurobiology of Depression

• Sponsor: University of Illinois at Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT01905267
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arms: 2
• Duration (Months): 51
• Patients Per Site Per Month: 0.6

Study Details

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	N/A

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
• 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: Mar 1, 2013
• Actual Primary Completion Date: Jun 1, 2017
• Actual Study Completion Date: Jun 1, 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 [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 [Baseline, 8 week]

   Self report adolescent depression total score. Range is 30-120 with higher scores meaning greater depressive symptoms.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	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)

• Informed Consent Form - Jul 31, 2014
• Study Protocol - Jun 30, 2014
• Statistical Analysis Plan - Jul 1, 2014

More Information

Publications

None provided.

• 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: Jul 23, 2013
• Last Update Posted: Jul 30, 2018
• Last Verified: Oct 1, 2017

• Keywords provided by Rachel Jacobs, Research Assistant Professor, Licensed Clinical Psychologist, University of Illinois at Chicago: mindfulness; relapse prevention; recovery; depression; adolescents
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

Participant Flow

Arm/Group Title	Treatment	Control
Arm/Group Description	Participants randomized to the experimental condition will receive 8 weeks of individual treatment with Rumination-Focused Cognitive Behavior Therapy 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.	Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study
Period Title: Overall Study
STARTED	17	16
COMPLETED	15	14
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Treatment	Control	Total
Arm/Group Description	Participants randomized to the experimental condition will receive 8 weeks of individual treatment with Rumination-Focused Cognitive Behavior Therapy 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.	Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study	Total of all reporting groups
Overall Participants	17	16	33
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	15.41 (1.97)	15.69 (1.89)	15.55 (1.91)
Sex: Female, Male (Count of Participants)
Female	9 52.9%	10 62.5%	19 57.6%
Male	8 47.1%	6 37.5%	14 42.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 5.9%	0 0%	1 3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 23.5%	4 25%	8 24.2%
White	8 47.1%	9 56.3%	17 51.5%
More than one race	4 23.5%	2 12.5%	6 18.2%
Unknown or Not Reported	0 0%	1 6.3%	1 3%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

completers sample

Arm/Group Title	Treatment	Control
Arm/Group Description	Participants randomized to the experimental condition will receive 8 weeks of individual treatment with Rumination-Focused Cognitive Behavior Therapy 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.	Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study
Measure Participants	15	14
Baseline	27.47 (3.94)	28.00 (6.82)
8 week	25.53 (4.22)	31.86 (10.99)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

8 week completers sample

Arm/Group Title	Treatment	Control
Arm/Group Description	Participants randomized to the experimental condition will receive 8 weeks of individual treatment with Rumination-Focused Cognitive Behavior Therapy 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.	Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study
Measure Participants	15	14
Baseline	64.41 (12.12)	63.50 (12.42)
Week 8	56.93 (13.22)	61.5 (13.77)

Adverse Events

Time Frame	two years following 8 week intervention period every six months
Adverse Event Reporting Description	Study staff informed of hospitalizations for suicidality or increasing depressive symptoms during course of KSADS clinical assessments
Arm/Group Title	Treatment		Control
Arm/Group Description	Participants randomized to the experimental condition will receive 8 weeks of individual treatment with Rumination-Focused Cognitive Behavior Therapy 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.		Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study
All Cause Mortality
	Treatment		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/16 (0%)
Serious Adverse Events
	Treatment		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		5/16 (31.3%)
Psychiatric disorders
Suicidality	0/17 (0%)	0	5/16 (31.3%)	5
Other (Not Including Serious) Adverse Events
	Treatment		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/16 (0%)

Limitations/Caveats

Small number of subjects

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.