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NCT Number: NCT07077291

MBCT and Escitalopram for Treatment-Resistant Depression in Older Adults

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.

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Key information

Conditions

Treatment-resistant Depression (TRD) Depressive Disorder Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders

Age range

60 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tangshan Gongren Hospital

Tangshan, Hebei, 063000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Escitalopram Hydrobromide

Drug

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

Primary outcomes

  1. Change in Cognitive Function

    Time frame: Baseline, 6 weeks, 12 weeks

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

  2. Change in Depression Severity

    Time frame: Baseline, 6 weeks, 12 weeks

    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.

  3. Change in Quality of Life

    Time frame: Baseline, 6 weeks, 12 weeks

    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.

Secondary outcomes

  1. Clinical Treatment Efficacy Rate

    Time frame: At 12 weeks

    Categorization of treatment effect as 'Significant', 'Effective', 'Average', or 'Ineffective' based on predefined changes in MoCA, HAM-D, and GQOLI-74 scores. The rate (%) of patients in each category was compared between groups.

  2. Incidence of Adverse Events

    Time frame: Baseline, 6 weeks, 12 weeks

    Monitoring and recording of all adverse events (AEs) reported by participants or observed by clinicians throughout the study. AEs were assessed for severity and relationship to the intervention.

Sponsors and collaborators

Lead sponsor

Yun Zhang

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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