Depression
Conditions
Keywords
mindfulness, relapse prevention, recovery, depression, adolescents
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.
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.
Interventions
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.
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* between the ages of 12 and 18 * history of major depressive disorder
Exclusion criteria
* braces * afraid of small spaces
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment 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. | 17 |
| Control Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study | 16 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 2 | 2 |
Baseline characteristics
| Characteristic | Control | Total | Treatment |
|---|---|---|---|
| Age, Continuous | 15.69 years STANDARD_DEVIATION 1.89 | 15.55 years STANDARD_DEVIATION 1.91 | 15.41 years STANDARD_DEVIATION 1.97 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 17 Participants | 8 Participants |
| Sex: Female, Male Female | 10 Participants | 19 Participants | 9 Participants |
| Sex: Female, Male Male | 6 Participants | 14 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 16 |
| other Total, other adverse events | 0 / 17 | 0 / 16 |
| serious Total, serious adverse events | 0 / 17 | 5 / 16 |
Outcome results
Primary
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
Time frame: Baseline, 8 week
Population: completers sample
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Change in Children's Depression Rating Scale - Revised | Baseline | 27.47 units on a scale | Standard Deviation 3.94 |
| Treatment | Change in Children's Depression Rating Scale - Revised | 8 week | 25.53 units on a scale | Standard Deviation 4.22 |
| Control | Change in Children's Depression Rating Scale - Revised | Baseline | 28.00 units on a scale | Standard Deviation 6.82 |
| Control | Change in Children's Depression Rating Scale - Revised | 8 week | 31.86 units on a scale | Standard Deviation 10.99 |
Secondary
Change in Reynolds Adolescent Depression Scale
Self report adolescent depression total score. Range is 30-120 with higher scores meaning greater depressive symptoms.
Time frame: Baseline, 8 week
Population: 8 week completers sample
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Change in Reynolds Adolescent Depression Scale | Baseline | 64.41 units on a scale | Standard Deviation 12.12 |
| Treatment | Change in Reynolds Adolescent Depression Scale | Week 8 | 56.93 units on a scale | Standard Deviation 13.22 |
| Control | Change in Reynolds Adolescent Depression Scale | Baseline | 63.50 units on a scale | Standard Deviation 12.42 |
| Control | Change in Reynolds Adolescent Depression Scale | Week 8 | 61.5 units on a scale | Standard Deviation 13.77 |