MBCT and Escitalopram for Treatment-Resistant Depression in Older Adults

Yun Zhang

Status: Completed

Conditions: Treatment-resistant Depression (TRD)

Treatments: Drug: Escitalopram Hydrobromide; Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)

Study type: Interventional

Funder types: Other

Identifiers

NCT07077291

2019-139

Details and patient eligibility

About

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.

Full 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.

Enrollment: 230 patients

Sex: All

Ages: 60 to 77 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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230 participants in 2 patient groups

Experimental: MBCT + Escitalopram Group

Experimental group

Description:

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).

Treatment:

Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)

Drug: Escitalopram Hydrobromide

Active Comparator: Escitalopram Alone Group

Active Comparator group

Description:

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

Treatment:

Drug: Escitalopram Hydrobromide