MBCT and Escitalopram for Treatment-Resistant Depression in Older Adults

NCT ID: NCT07077291

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2022-05-30

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental: MBCT + Escitalopram Group

Participants received mindfulness-based cognitive therapy (MBCT) in weekly 120-minute group sessions for 12 weeks, in addition to daily oral administration of escitalopram hydrobromide (20mg/day).

Group Type: EXPERIMENTAL

Mindfulness-Based Cognitive Therapy (MBCT)

Intervention Type: BEHAVIORAL

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.

Escitalopram Hydrobromide

Intervention Type: DRUG

Oral administration of escitalopram hydrobromide tablets, 20mg once daily (qd) for the entire 12-week study duration.

Active Comparator: Escitalopram Alone Group

Participants received daily oral administration of escitalopram hydrobromide (20mg/day) and served as the control group.

Group Type: ACTIVE_COMPARATOR

Escitalopram Hydrobromide

Intervention Type: DRUG

Oral administration of escitalopram hydrobromide tablets, 20mg once daily (qd) for the entire 12-week study duration.

Interventions

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.

Intervention Type: BEHAVIORAL

Escitalopram Hydrobromide

Oral administration of escitalopram hydrobromide tablets, 20mg once daily (qd) for the entire 12-week study duration.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Aged between 60 and 77 years.
• Montreal Cognitive Assessment (MoCA) scores ranging from 5 to 17.
• Diagnosis of persistent and treatment-resistant depression according to DSM-5 criteria.
• Maintained consistent use of escitalopram hydrobromide for the previous 6 months.
• Ability to independently perform daily tasks.
• Provided written informed consent and willing to adhere to study procedures and follow-up.

Exclusion Criteria

• Primary diagnosis of schizophrenia, bipolar disorder, or other significant mental health conditions other than depression.
• Presence of advanced cancer, end-stage heart disease, or severe liver or kidney dysfunction.
• Recent history (within 12 months) of substance abuse or addiction.
• Significant visual or hearing impairments that would hinder participation.
• Participation in mindfulness therapy or similar CBT within the last year.
• Language comprehension or expression challenges precluding participation.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 77 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yun Zhang

OTHER

Sponsor Role: lead

Responsible Party

Yun Zhang

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Tangshan Gongren Hospital

Tangshan, Hebei, China

Countries

China

Other Identifiers

2019-139

Identifier Type: -

Identifier Source: org_study_id