MBCT and Escitalopram for Treatment-Resistant Depression in Older Adults

NCT07077291 | Completed

• 1 other identifier: 2019-139
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment-resistant Depression (TRD)

Outcome Measures

Primary Outcomes (3)

• Change in Cognitive Function

  Measured by the Montreal Cognitive Assessment (MoCA). The scale score ranges from 0-30, with higher scores indicating better cognitive function.

  Baseline, 6 weeks, 12 weeks

• Change in Depression Severity

  Measured by the 17-item Hamilton Depression Rating Scale (HAM-D-17). The scale score ranges from 0-52, with lower scores indicating less severe depressive symptoms.

  Baseline, 6 weeks, 12 weeks

• Change in Quality of Life

  Measured by the General Quality of Life Index-74 (GQOLI-74). The total score is calculated from 74 items, with higher scores indicating a better quality of life.

  Baseline, 6 weeks, 12 weeks

Secondary Outcomes (2)

• Clinical Treatment Efficacy Rate

  At 12 weeks

• Incidence of Adverse Events

  Baseline, 6 weeks, 12 weeks

Study Arms (2)

Experimental: MBCT + Escitalopram Group

EXPERIMENTAL

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).

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

Active Comparator: Escitalopram Alone Group

ACTIVE COMPARATOR

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

Drug: Escitalopram Hydrobromide

Interventions

Mindfulness-Based Cognitive Therapy (MBCT) 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.

Experimental: MBCT + Escitalopram Group

Escitalopram Hydrobromide DRUG

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

Active Comparator: Escitalopram Alone Group; Experimental: MBCT + Escitalopram Group

Eligibility Criteria

• Age: 60 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yun Zhang: lead

Study Sites (1)

Tangshan Gongren Hospital

Tangshan, Hebei, 063000, China

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 22, 2025
• Study Start: February 1, 2020
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

CN (1)