Neural Mechanisms of Meditation Training in Healthy and Depressed Adolescents: An MRI Connectome Study PART 2
Study Details
Study Description
Brief Summary
The primary objective will be to study changes in putamen connectivity and depression severity in depressed teens with meditation training. H1: Putamen node strength will increase in the training group compared to the active controls. H2: This increase in node strength will correlate with practice amount recorded by participants. H3: There will be a significant reduction in self-rated depression symptoms following the training as measured by the Reynolds Adolescent Depression Scale (RADS-2), compared to controls. H4: This reduction will correlate with the increase in putamen node strength.
Design and Outcomes: The current research study design will utilize an individually randomized group treatment, open-label, active-controlled clinical trial to test the efficacy and safety of the investigator's innovative mindfulness meditation intervention (Training for Awareness Resilience and Action [TARA]) on the primary outcome (Putamen structural node strength) and secondary outcome (depression symptoms measured using Reynolds Adolescent Depression Scale [RADS-2]) in depressed adolescents between the ages of 14 to 18 years old.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental: TARA Training Behavioral: Training for Awareness, Resilience, and Action (TARA) This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA) |
Behavioral: TARA
This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)
|
| Active Comparator: Control: Psycho-Education Behavioral: Training for Awareness, Resilience, and Action (TARA) without the mindfulness meditation components This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA) without the mindfulness meditation components |
Behavioral: Psycho-Education
This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA) without the mindfulness meditation components
|
Outcome Measures
Primary Outcome Measures
- Change in Putamen node strength [Baseline/randomization and 12 weeks after baseline/randomization]
Change in the Putamen node strength assessed using diffusion MRI
Secondary Outcome Measures
- Change in Depression Symptoms [Baseline/randomization and 12 weeks after baseline/randomization]
Change in the score on the Reynold's Adolescent Depression Scale-2 (RADS-2). The RADS-2 has a possible range of 30 to 120. Higher scores represent higher levels of depression.
Eligibility Criteria
Criteria
The inclusion criteria: unmedicated adolescents with mild to moderate depression, of both sexes, 14-18 years old, with depression symptoms corresponding to RADS-2 t-scores of 61-69 (t-scores below 61 are the normal range, t-scores 70 and above are considered to be severe clinical depression), under the care of a primary care doctor.
Exclusion criteria are psychiatric comorbidities other than anxiety disorder, severe suicidal ideation, as well as MRI contraindications (ferromagnetic objects on or inside the body, e.g. braces) and pregnancy.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of California, San Francisco
Investigators
- Principal Investigator: Olga Tymofiyeva, PhD, University of California, San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-29083 (c)