NCT07077291

MBCT and Escitalopram for Treatment-Resistant Depression in Older Adults

Combining Mindfulness-Based Cognitive Therapy With Escitalopram for Cognitive and Emotional Recovery in Older Adults With Treatment-Resistant Depression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Yun Zhang · Academic / Other
• Sex: All
• Age: 60 Years – 77 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized controlled trial designed to investigate the synergistic effects of combining mindfulness-based cognitive therapy (MBCT) with escitalopram hydrobromide versus escitalopram alone on cognitive function, depressive symptoms, and quality of life in older adults diagnosed with treatment-resistant depression (TRD) and cognitive impairment.

Detailed description

Treatment-resistant depression (TRD) in older adults presents a significant clinical challenge, often accompanied by cognitive impairment that affects daily functioning and well-being. While escitalopram is a standard pharmacological treatment, monotherapy may be insufficient for this population. Mindfulness-Based Cognitive Therapy (MBCT) has emerged as a promising psychotherapeutic intervention for depression by promoting awareness and altering negative thought patterns. This study aimed to evaluate if an integrated approach of MBCT plus escitalopram would yield superior outcomes compared to escitalopram alone. A total of 230 older adults with TRD were randomized to either a combined therapy group or a medication-only control group. Assessments of cognitive function (MoCA), depression severity (HAM-D), and quality of life (GQOLI-74) were conducted at baseline, 6 weeks, and 12 weeks to determine the efficacy of the combined intervention.

Conditions

• Treatment-resistant Depression (TRD)

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness-Based Cognitive Therapy (MBCT)	A group intervention delivered by a psychiatrist and two assistants. Sessions were 120 minutes, once per week, for 12 weeks. Content included mindfulness exercises such as 3-minute breathing space, body scanning, mindfulness walking, meditation, and cognitive therapy techniques to observe connections between thoughts, emotions, and behavior.
DRUG	Escitalopram Hydrobromide	Oral administration of escitalopram hydrobromide tablets, 20mg once daily (qd) for the entire 12-week study duration.

Timeline

• Start date: 2020-02-01
• Primary completion: 2022-05-30
• Completion: 2022-05-30
• First posted: 2025-07-22
• Last updated: 2025-07-22

Locations

1 site across 1 country: China