Treatment-resistant Depression (TRD)NCT07077291
MBCT and Escitalopram for Treatment-Resistant Depression in Older Adults
A study testing Mindfulness-Based Cognitive Therapy (MBCT) and Escitalopram Hydrobromide in people with Treatment-resistant Depression (TRD), run by Yun Zhang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 77 years
- Conditions the study is for
- Treatment-resistant Depression (TRD)
- What is being tested?
- Mindfulness-Based Cognitive Therapy (MBCT) and Escitalopram Hydrobromide
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Combining Mindfulness-Based Cognitive Therapy With Escitalopram for Cognitive and Emotional Recovery in Older Adults With Treatment-Resistant Depression
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.
Read the 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)
- Being tested
- Mindfulness-Based Cognitive Therapy (MBCT), Escitalopram Hydrobromide
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive Therapy (MBCT)Behavioural
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 HydrobromideDrug
Oral administration of escitalopram hydrobromide tablets, 20mg once daily (qd) for the entire 12-week study duration.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Escitalopram Hydrobromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 weeks, 12 weeks
Secondary outcomes (2)
Clinical Treatment Efficacy Rate
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.
Measured: At 12 weeks
Incidence of Adverse Events
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.
Measured: Baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Feb 2020
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment-resistant Depression (TRD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yun Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yun Zhang, Tangshan Gongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077291
- Sponsor's protocol ID
- 2019-139
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wei Z, Zhang S, Ma J, Zhang Y, Li Y, Wen A. Combining Mindfulness-Based Cognitive Therapy With Escitalopram for Cognitive and Emotional Recovery in Older Adults With Treatment-Resistant Depression. J Clin Psychol. 2026 Aug;82(8):1111-1121. doi: 10.1002/jclp.70137. Epub 2026 Apr 23.
PubMed 42023679
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Mindfulness-Based Cognitive Therapy With Escitalopram for Cognitive and Emotional Recovery in Older Adults With Treatment-Resistant Depression
- ClinicalTrials.gov ID
- NCT07077291
- Acronym / sponsor ID
- 2019-139
- Conditions
- Treatment-resistant Depression (TRD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Yun ZhangUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: MBCT + Escitalopram Group | Experimental | Behavioral: Mindfulness-Based Cognitive Therapy (MBCT), Drug: Escitalopram HydrobromideParticipants 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). |
| Active Comparator: Escitalopram Alone Group | Active comparator | Drug: Escitalopram HydrobromideParticipants received daily oral administration of escitalopram hydrobromide (20mg/day) and served as the control group. |
Who may qualify
- Ages
- 60 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Experimental: MBCT + Escitalopram Group |
| Escitalopram HydrobromideOral administration of escitalopram hydrobromide tablets, 20mg once daily (qd) for the entire 12-week study duration. | Drug | Active Comparator: Escitalopram Alone Group, Experimental: MBCT + Escitalopram Group |
Primary outcome
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.
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.
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.
2 secondary outcomes
Clinical Treatment Efficacy Rate
Time frame: At 12 weeks
Incidence of Adverse Events
Time frame: Baseline, 6 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Derived from this study: PubMed 42023679Wei Z, Zhang S, Ma J, Zhang Y, Li Y, Wen A. Combining Mindfulness-Based Cognitive Therapy With Escitalopram for Cognitive and Emotional Recovery in Older Adults With Treatment-Resistant Depression. J Clin Psychol. 2026 Aug;82(8):1111-1121. doi: 10.1002/jclp.70137. Epub 2026 Apr 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Cognitive Therapy (MBCT) and Escitalopram Hydrobromide in people with Treatment-resistant Depression (TRD), run by Yun Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Function (time frame: Baseline, 6 weeks, 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07077291, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.