Neural Mechanisms of Meditation Training in Healthy and Depressed Adolescents: An MRI Connectome Study PART 2

Not Applicable

Recruiting

• Conditions: Depression Mild; Depression, Teen; Depression Moderate
• Interventions: Behavioral: Psycho-Education; Behavioral: TARA

• Registration Number: NCT05267340
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-02-23
• Study First Posted: 2022-03-04
• Study Start: 2023-02-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control: Psycho-Education	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
Experimental: TARA Training	TARA	Behavioral: Training for Awareness, Resilience, and Action (TARA) This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

UCSF; 🇺🇸 San Francisco, California, United States