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Mindfulness Intervention to Study the Neurobiology of Depression (MIND)

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Depression
Intervention Behavioral: Rumination-Focused Cognitive Behavior Therapy
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Control
Hide 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
Reason Not Completed
Physician Decision             2             2
Arm/Group Title Treatment Control Total
Hide 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 Number of Baseline Participants 17 16 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 16 participants 33 participants
15.41  (1.97) 15.69  (1.89) 15.55  (1.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 33 participants
Female
9
  52.9%
10
  62.5%
19
  57.6%
Male
8
  47.1%
6
  37.5%
14
  42.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 33 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.9%
0
   0.0%
1
   3.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  23.5%
4
  25.0%
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
   0.0%
1
   6.3%
1
   3.0%
1.Primary Outcome
Title Change in Children's Depression Rating Scale - Revised
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
completers sample
Arm/Group Title Treatment Control
Hide 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
Overall Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
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
Hide Description Self report adolescent depression total score. Range is 30-120 with higher scores meaning greater depressive symptoms.
Time Frame Baseline, 8 week
Hide Outcome Measure Data
Hide Analysis Population Description
8 week completers sample
Arm/Group Title Treatment Control
Hide 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
Overall Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 64.41  (12.12) 63.50  (12.42)
Week 8 56.93  (13.22) 61.5  (13.77)
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
Hide 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 (%) Affected / at Risk (%)
Total   0/17 (0.00%)      0/16 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      5/16 (31.25%)    
Psychiatric disorders     
Suicidality * [1]  0/17 (0.00%)  0 5/16 (31.25%)  5
*
Indicates events were collected by non-systematic assessment
[1]
Five participants were hospitalized for suicidality or suicidal gestures.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/16 (0.00%)    
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.
Results Point of Contact
Name/Title: Rachel Jacobs
Organization: University of Illinois at Chicago
Phone: 3124139178 ext 312
Responsible Party: Rachel Jacobs, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01905267     History of Changes
Other Study ID Numbers: 2012-0689
First Submitted: July 10, 2013
First Posted: July 23, 2013
Results First Submitted: August 3, 2017
Results First Posted: July 30, 2018
Last Update Posted: July 30, 2018