Depressive Disorder, Treatment-ResistantNCT07847242
Brain Connectivity and Inflammatory Markers During Short-Term Psychotherapy for Treatment-Resistant Depression
A study testing Short-Term Dynamic Psychotherapy and Mindfulness-Based Cognitive Therapy in people with Depressive Disorder, Treatment-Resistant, run by Korea University Ansan Hospital at 1 site in South Korea.
Trial summary
Some adults continue to experience depression despite treatment with antidepressant medicines. This study aimed to explore relationships between depression symptoms, brain function, and blood markers of inflammation, and changes in these measures during a course of psychotherapy. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Treatment-Resistant
- What is being tested?
- Short-Term Dynamic Psychotherapy and Mindfulness-Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Feb 2022to 26 Aug 2023
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants:
- Aged 19 to 65 years.
- All four grandparents are Korean.
- Able to understand the study information and provide voluntary informed consent.
- Participants with treatment-resistant depression:
- Persistent depressive symptoms despite treatment with at least two antidepressants for at least 6 weeks.
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- A 17-item Hamilton Depression Rating Scale (HAM-D) score of 17 or higher.
- A history of at least two major depressive episodes.
- First major depressive episode at age 14 years or older and before age 50 years.
- Healthy participants:
- No current or past psychiatric disorder.
Who cannot join
- History of bipolar disorder or psychosis.
- History of alcohol or other substance dependence predating the onset of depression.
- History of intellectual disability.
- A parent or grandparent who is not Korean.
- History of significant central nervous system disease, including traumatic brain injury, loss of consciousness, Parkinson's disease, epilepsy, Alzheimer's disease, or Huntington's disease.
- Current infection, infection within the preceding 3 months, or an immunocompromised state. Immunocompromised states include congenital immune impairment and acquired conditions associated with immunosuppressive treatment, previous or current chemotherapy, or human immunodeficiency virus (HIV) infection.
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- Ongoing long-term use of oral corticosteroids or nonsteroidal anti-inflammatory drugs.
- Pregnancy or breastfeeding.
- Clinically significant suicide risk in the judgment of the treating psychiatrist or investigator.
- Thoughts or intent to harm others.
- Use of an unapproved drug within the preceding 30 days or current participation in a related clinical study.
- Clinically significant abnormal screening findings in the judgment of the principal investigator.
- An acute or chronic illness that makes participation unsuitable in the investigator's judgment.
- Likely inability to follow study procedures and requirements.
- Coronavirus disease 2019 (COVID-19) vaccination within the preceding month.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea University Ansan Hospital
Ansan, Gyeonggi-do, 15355
About this study
Official title: The Relationship Between Inflammatory Markers in Peripheral Blood and Functional Brain Network in Patients With Treatment-Resistant Depression: Pilot Study
Some adults continue to experience depression despite treatment with antidepressant medicines. This study aimed to explore relationships between depression symptoms, brain function, and blood markers of inflammation, and changes in these measures during a course of psychotherapy.
Adults with treatment-resistant depression were assigned to receive 10 weekly sessions of individual short-term dynamic psychotherapy, a form of talking therapy, alongside their ongoing medication. Healthy adults served as a reference group and received no study treatment.
Assessments were planned at the start of participation and at a 10-week follow-up. These included depression ratings, quality-of-life questionnaires, blood tests, and measurements of brain activity. The study aimed to compare initial measurements between participants with depression and healthy adults and to explore changes over time within each group.
Read the detailed description
This was a single-center, prospective, nonrandomized interventional pilot study conducted at the Department of Psychiatry, Korea University Ansan Hospital, Republic of Korea.
The protocol initially planned a mindfulness-based cognitive therapy (MBCT) group, an individual psychotherapy group, and a healthy reference group. A protocol amendment removed the planned random allocation between the two psychotherapy groups because irregular recruitment could delay treatment while waiting to form MBCT groups. In the study as conducted, all enrolled participants with treatment-resistant depression were assigned to individual short-term dynamic psychotherapy alongside ongoing pharmacotherapy. No participants received MBCT. Healthy participants served as a reference group for clinical and biological measurements.
The broader protocol included clinical assessments, peripheral inflammatory and neurotrophic markers, and measures of brain function. Functional near-infrared spectroscopy (fNIRS) was specified to examine prefrontal cortical activity and connectivity. Functional magnetic resonance imaging (fMRI) and magnetic resonance spectroscopy (MRS) were used to examine resting-state brain networks and neurochemical measures. Additional planned procedures included stool collection for exploratory gut microbiome analyses and storage of peripheral blood mononuclear cells for laboratory research involving induced pluripotent stem cells.
- Conditions
- Depressive Disorder, Treatment-Resistant
- Being tested
- Short-Term Dynamic Psychotherapy, Mindfulness-Based Cognitive Therapy
- Keywords
- Short-Term Dynamic Psychotherapy, Psychodynamic Psychotherapy, Inflammatory Biomarkers, Functional Near-Infrared Spectroscopy, Functional Connectivity, Quality of Life
- 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.
Short-Term Dynamic PsychotherapyBehavioural
Also called STDP
Individual short-term dynamic psychotherapy was provided once weekly over a planned 10-week course, in addition to ongoing pharmacotherapy.
Mindfulness-Based Cognitive TherapyBehavioural
Also called MBCT
The protocol planned group mindfulness-based cognitive therapy comprising 10 weekly 50-minute sessions, to be delivered via Zoom or in person at the hospital. This intervention was not implemented, and no participants received it.
| Study group | Role | What they receive |
|---|---|---|
| Short-Term Dynamic Psychotherapy | Experimental | Fifteen participants with treatment-resistant depression were assigned to receive 10 weekly sessions of individual short-term dynamic psychotherapy alongside ongoing pharmacotherapy. Assessments were scheduled at baseline and week 10. Receives: Behavioral: Short-Term Dynamic Psychotherapy |
| Healthy Reference Group | No intervention | Sixteen healthy participants were enrolled as a reference group. They received no study treatment. Clinical and biological assessments were scheduled at baseline and week 10. |
| Mindfulness-Based Cognitive Therapy (Not Implemented) | Experimental | This arm was specified in the approved protocol to receive a 10-week course of group mindfulness-based cognitive therapy. The arm was not implemented. No participants were enrolled, and the intervention was not delivered. Receives: Behavioral: Mindfulness-Based Cognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in 17-Item Hamilton Depression Rating Scale (HAM-D) Total Score
Depressive symptom severity was assessed by the treating psychiatrist using the Korean version of the 17-item Hamilton Depression Rating Scale (K-HDRS). Total scores range from 0 to 52, with higher scores indicating more severe depressive symptoms. Change in total score was assessed between baseline and week 10.
Measured: Baseline and week 10
Change from Baseline in Mean Prefrontal Functional Connectivity (fNIRS)
Resting-state functional connectivity was assessed from 5-minute recordings using a 48-channel prefrontal fNIRS system (NIRSIT). Pairwise Pearson correlations were calculated from preprocessed oxygenated hemoglobin time series, transformed using Fisher's r-to-z transformation, and summarized as mean connectivity across the recorded prefrontal network. Connectivity values are dimensionless. Change was assessed between baseline and week 10.
Measured: Baseline and week 10
Change from Baseline in the Area Under the Small-Worldness Curve Across Correlation Thresholds (fNIRS)
Small-worldness of the prefrontal functional network was calculated from resting-state fNIRS oxygenated hemoglobin signals. Binary networks were constructed using Pearson correlation thresholds of 0.2, 0.3, 0.4, 0.5, and 0.6. Small-worldness was summarized as the area under the curve across these thresholds using trapezoidal integration. This measure is dimensionless. Change was assessed between baseline and week 10.
Measured: Baseline and week 10
Change from Baseline in the Area Under the Mean Clustering Coefficient Curve Across Correlation Thresholds (fNIRS)
Mean clustering coefficient of the prefrontal functional network was calculated from resting-state fNIRS oxygenated hemoglobin signals. Binary networks were constructed using Pearson correlation thresholds of 0.2, 0.3, 0.4, 0.5, and 0.6. Mean clustering coefficient was summarized as the area under the curve across these thresholds using trapezoidal integration. This measure is dimensionless. Change was assessed between baseline and week 10.
Measured: Baseline and week 10
Change from Baseline in the Area Under the Local Efficiency Curve Across Correlation Thresholds (fNIRS)
Local efficiency of the prefrontal functional network was calculated from resting-state fNIRS oxygenated hemoglobin signals. Binary networks were constructed using Pearson correlation thresholds of 0.2, 0.3, 0.4, 0.5, and 0.6. Local efficiency was summarized as the area under the curve across these thresholds using trapezoidal integration. This measure is dimensionless. Change was assessed between baseline and week 10.
Measured: Baseline and week 10
Change from Baseline in the Area Under the Global Efficiency Curve Across Correlation Thresholds (fNIRS)
Global efficiency of the prefrontal functional network was calculated from resting-state fNIRS oxygenated hemoglobin signals. Binary networks were constructed using Pearson correlation thresholds of 0.2, 0.3, 0.4, 0.5, and 0.6. Global efficiency was summarized as the area under the curve across these thresholds using trapezoidal integration. This measure is dimensionless. Change was assessed between baseline and week 10.
Measured: Baseline and week 10
Change from Baseline in Resting-State Brain Functional Connectivity Assessed by fMRI
Resting-state functional magnetic resonance imaging (fMRI) was used to assess brain functional connectivity. The outcome is change in functional connectivity from baseline to week 10.
Measured: Baseline and week 10
Brain Metabolite Concentrations Measured by Magnetic Resonance Spectroscopy (MRS)
Brain metabolite concentrations were assessed using magnetic resonance spectroscopy (MRS). The protocol specified measurements at baseline and week 10.
Measured: Baseline and week 10
Secondary outcomes (10)
Change from Baseline in the Sum of the Four World Health Organization Quality of Life Assessment Instrument-Brief Form (WHOQOL-BREF) Domain Scores
Quality of life was assessed using the Korean version of the WHOQOL-BREF. A study-defined summary score was calculated by summing the four domain scores, each expressed on a 4-20 scale. The two general items (Q1 and Q2) were excluded. Summary scores range from 16 to 80, with higher scores indicating better quality of life. Change was assessed between baseline and week 10.
Measured: Baseline and week 10
Change from Baseline in Serum Interleukin-6 (IL-6) Concentration
Serum interleukin-6 (IL-6) was measured using a magnetic bead-based multiplex immunoassay on a Luminex 200 platform. Assay-reported values were expressed in pg/mL. Change was assessed between baseline and week 10.
Measured: Baseline and week 10
Change from Baseline in Serum Tumor Necrosis Factor-Alpha (TNF-alpha) Concentration
Serum tumor necrosis factor-alpha (TNF-alpha) was measured using a magnetic bead-based multiplex immunoassay on a Luminex 200 platform. Assay-reported values were expressed in pg/mL. Change was assessed between baseline and week 10.
Measured: Baseline and week 10
Change from Baseline in C-Reactive Protein (CRP) Concentration
C-reactive protein (CRP) was measured in the hospital clinical laboratory using automated immunoturbidimetry. Values were expressed in mg/L. Change was assessed between baseline and week 10.
Measured: Baseline and week 10
Change from Baseline in Serum Brain-Derived Neurotrophic Factor (BDNF) Concentration
Serum brain-derived neurotrophic factor (BDNF) was measured using a magnetic bead-based multiplex immunoassay on a Luminex 200 platform. Values were expressed in pg/mL. Change was assessed between baseline and week 10.
Measured: Baseline and week 10
Change from Baseline in Serum Interleukin-1 Beta (IL-1beta) Concentration
Serum interleukin-1 beta (IL-1beta) was measured using a magnetic bead-based multiplex immunoassay on a Luminex 200 platform. Assay-reported values were expressed in pg/mL. Change was assessed between baseline and week 10.
Measured: Baseline and week 10
Change from Baseline in Serum Interleukin-10 (IL-10) Concentration
Serum interleukin-10 (IL-10) was measured using a magnetic bead-based multiplex immunoassay on a Luminex 200 platform. Assay-reported values were expressed in pg/mL. Change was assessed between baseline and week 10.
Measured: Baseline and week 10
Change from Baseline in Erythrocyte Sedimentation Rate (ESR)
Erythrocyte sedimentation rate (ESR) was measured in anticoagulated whole blood using the hospital laboratory's routine automated method. Values were expressed in mm/h. Change was assessed between baseline and week 10.
Measured: Baseline and week 10
Five Facet Mindfulness Questionnaire (FFMQ) Mean Item Score
Mindfulness was assessed using the 39-item Korean version of the Five Facet Mindfulness Questionnaire (FFMQ). The questionnaire covers observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience. Items are rated from 1 to 5. The overall score was recorded as a mean item score on a 1-5 scale, with higher scores indicating greater mindfulness. Assessments were recorded at baseline and week 10.
Measured: Baseline and week 10
Relative Abundance of Gut Microbial Taxa
Gut microbiota composition was assessed by 16S ribosomal ribonucleic acid (rRNA) gene amplicon analysis of stool samples targeting the V3-V4 region. Relative abundances of microbial taxa were calculated at taxonomic levels from phylum to species and expressed as proportions ranging from 0 to 1. Assessments were recorded at baseline and week 10.
Measured: Baseline and week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start15 Feb 2022
- Primary completion26 Aug 2023
- Study completion26 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, Treatment-ResistantStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The protocol specified three parallel groups: mindfulness-based cognitive therapy (MBCT), individual psychotherapy, and a healthy reference group. Planned random allocation between the psychotherapy groups was subsequently removed. In the study as conducted, 15 participants with treatment-resistant depression received short-term dynamic psychotherapy alongside ongoing pharmacotherapy, and 16 healthy participants received no study treatment. The planned MBCT arm was not implemented, and no participants were enrolled in that arm. Assessments were scheduled at baseline and week 10.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Ansan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea, Konyang University Hospital
- Responsible party
- Principal investigator, Shin, Sangho, Konyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847242
- Sponsor's protocol ID
- 2021AS0372
- Other IDs
- 2022R1A2C1010195
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the findings reported in publications arising from this clinical trial may be made available upon reasonable request, subject to institutional and ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Inflammatory Markers in Peripheral Blood and Functional Brain Network in Patients With Treatment-Resistant Depression: Pilot Study
- ClinicalTrials.gov ID
- NCT07847242
- Acronym / sponsor ID
- 2021AS0372
- Conditions
- Depressive Disorder, Treatment-Resistant
- Keywords
- Short-Term Dynamic Psychotherapy, Psychodynamic Psychotherapy, Inflammatory Biomarkers, Functional Near-Infrared Spectroscopy, Functional Connectivity, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Korea University Ansan HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea, Konyang University Hospital
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 26 Aug 2023 (actual)
- Study completion
- 26 Aug 2023 (actual)
- First posted
- 29 Sep 2026 (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.
Some adults continue to experience depression despite treatment with antidepressant medicines. This study aimed to explore relationships between depression symptoms, brain function, and blood markers of inflammation, and changes in these measures during a course of psychotherapy.
Adults with treatment-resistant depression were assigned to receive 10 weekly sessions of individual short-term dynamic psychotherapy, a form of talking therapy, alongside their ongoing medication. Healthy adults served as a reference group and received no study treatment.
Assessments were planned at the start of participation and at a 10-week follow-up. These included depression ratings, quality-of-life questionnaires, blood tests, and measurements of brain activity. The study aimed to compare initial measurements between participants with depression and healthy adults and to explore changes over time within each group.
Detailed description
This was a single-center, prospective, nonrandomized interventional pilot study conducted at the Department of Psychiatry, Korea University Ansan Hospital, Republic of Korea.
The protocol initially planned a mindfulness-based cognitive therapy (MBCT) group, an individual psychotherapy group, and a healthy reference group. A protocol amendment removed the planned random allocation between the two psychotherapy groups because irregular recruitment could delay treatment while waiting to form MBCT groups. In the study as conducted, all enrolled participants with treatment-resistant depression were assigned to individual short-term dynamic psychotherapy alongside ongoing pharmacotherapy. No participants received MBCT. Healthy participants served as a reference group for clinical and biological measurements.
The broader protocol included clinical assessments, peripheral inflammatory and neurotrophic markers, and measures of brain function. Functional near-infrared spectroscopy (fNIRS) was specified to examine prefrontal cortical activity and connectivity. Functional magnetic resonance imaging (fMRI) and magnetic resonance spectroscopy (MRS) were used to examine resting-state brain networks and neurochemical measures. Additional planned procedures included stool collection for exploratory gut microbiome analyses and storage of peripheral blood mononuclear cells for laboratory research involving induced pluripotent stem cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The protocol specified three parallel groups: mindfulness-based cognitive therapy (MBCT), individual psychotherapy, and a healthy reference group. Planned random allocation between the psychotherapy groups was subsequently removed. In the study as conducted, 15 participants with treatment-resistant depression received short-term dynamic psychotherapy alongside ongoing pharmacotherapy, and 16 healthy participants received no study treatment. The planned MBCT arm was not implemented, and no participants were enrolled in that arm. Assessments were scheduled at baseline and week 10.
| Arm | Type | Receives |
|---|---|---|
| Short-Term Dynamic Psychotherapy | Experimental | Behavioral: Short-Term Dynamic PsychotherapyFifteen participants with treatment-resistant depression were assigned to receive 10 weekly sessions of individual short-term dynamic psychotherapy alongside ongoing pharmacotherapy. Assessments were scheduled at baseline and week 10. |
| Healthy Reference Group | No intervention | –Sixteen healthy participants were enrolled as a reference group. They received no study treatment. Clinical and biological assessments were scheduled at baseline and week 10. |
| Mindfulness-Based Cognitive Therapy (Not Implemented) | Experimental | Behavioral: Mindfulness-Based Cognitive TherapyThis arm was specified in the approved protocol to receive a 10-week course of group mindfulness-based cognitive therapy. The arm was not implemented. No participants were enrolled, and the intervention was not delivered. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 19 to 65 years.
- All four grandparents are Korean.
- Able to understand the study information and provide voluntary informed consent.
- Persistent depressive symptoms despite treatment with at least two antidepressants for at least 6 weeks.
- A 17-item Hamilton Depression Rating Scale (HAM-D) score of 17 or higher.
Key exclusion criteria (15 listed)
- History of bipolar disorder or psychosis.
- History of alcohol or other substance dependence predating the onset of depression.
- History of intellectual disability.
- A parent or grandparent who is not Korean.
- History of significant central nervous system disease, including traumatic brain injury, loss of consciousness, Parkinson's disease, epilepsy, Alzheimer's disease, or Huntington's disease.
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 |
|---|---|---|
| Short-Term Dynamic PsychotherapyAlso: STDPIndividual short-term dynamic psychotherapy was provided once weekly over a planned 10-week course, in addition to ongoing pharmacotherapy. | Behavioural | Short-Term Dynamic Psychotherapy |
| Mindfulness-Based Cognitive TherapyAlso: MBCTThe protocol planned group mindfulness-based cognitive therapy comprising 10 weekly 50-minute sessions, to be delivered via Zoom or in person at the hospital. This intervention was not implemented, and no participants received it. | Behavioural | Mindfulness-Based Cognitive Therapy (Not Implemented) |
Primary outcome
Change from Baseline in 17-Item Hamilton Depression Rating Scale (HAM-D) Total Score
Time frame: Baseline and week 10
Depressive symptom severity was assessed by the treating psychiatrist using the Korean version of the 17-item Hamilton Depression Rating Scale (K-HDRS). Total scores range from 0 to 52, with higher scores indicating more severe depressive symptoms. Change in total score was assessed between baseline and week 10.
Change from Baseline in Mean Prefrontal Functional Connectivity (fNIRS)
Time frame: Baseline and week 10
Resting-state functional connectivity was assessed from 5-minute recordings using a 48-channel prefrontal fNIRS system (NIRSIT). Pairwise Pearson correlations were calculated from preprocessed oxygenated hemoglobin time series, transformed using Fisher's r-to-z transformation, and summarized as mean connectivity across the recorded prefrontal network. Connectivity values are dimensionless. Change was assessed between baseline and week 10.
Change from Baseline in the Area Under the Small-Worldness Curve Across Correlation Thresholds (fNIRS)
Time frame: Baseline and week 10
Small-worldness of the prefrontal functional network was calculated from resting-state fNIRS oxygenated hemoglobin signals. Binary networks were constructed using Pearson correlation thresholds of 0.2, 0.3, 0.4, 0.5, and 0.6. Small-worldness was summarized as the area under the curve across these thresholds using trapezoidal integration. This measure is dimensionless. Change was assessed between baseline and week 10.
Change from Baseline in the Area Under the Mean Clustering Coefficient Curve Across Correlation Thresholds (fNIRS)
Time frame: Baseline and week 10
Mean clustering coefficient of the prefrontal functional network was calculated from resting-state fNIRS oxygenated hemoglobin signals. Binary networks were constructed using Pearson correlation thresholds of 0.2, 0.3, 0.4, 0.5, and 0.6. Mean clustering coefficient was summarized as the area under the curve across these thresholds using trapezoidal integration. This measure is dimensionless. Change was assessed between baseline and week 10.
Change from Baseline in the Area Under the Local Efficiency Curve Across Correlation Thresholds (fNIRS)
Time frame: Baseline and week 10
Local efficiency of the prefrontal functional network was calculated from resting-state fNIRS oxygenated hemoglobin signals. Binary networks were constructed using Pearson correlation thresholds of 0.2, 0.3, 0.4, 0.5, and 0.6. Local efficiency was summarized as the area under the curve across these thresholds using trapezoidal integration. This measure is dimensionless. Change was assessed between baseline and week 10.
Change from Baseline in the Area Under the Global Efficiency Curve Across Correlation Thresholds (fNIRS)
Time frame: Baseline and week 10
Global efficiency of the prefrontal functional network was calculated from resting-state fNIRS oxygenated hemoglobin signals. Binary networks were constructed using Pearson correlation thresholds of 0.2, 0.3, 0.4, 0.5, and 0.6. Global efficiency was summarized as the area under the curve across these thresholds using trapezoidal integration. This measure is dimensionless. Change was assessed between baseline and week 10.
Change from Baseline in Resting-State Brain Functional Connectivity Assessed by fMRI
Time frame: Baseline and week 10
Resting-state functional magnetic resonance imaging (fMRI) was used to assess brain functional connectivity. The outcome is change in functional connectivity from baseline to week 10.
Brain Metabolite Concentrations Measured by Magnetic Resonance Spectroscopy (MRS)
Time frame: Baseline and week 10
Brain metabolite concentrations were assessed using magnetic resonance spectroscopy (MRS). The protocol specified measurements at baseline and week 10.
10 secondary outcomes
Change from Baseline in the Sum of the Four World Health Organization Quality of Life Assessment Instrument-Brief Form (WHOQOL-BREF) Domain Scores
Time frame: Baseline and week 10
Change from Baseline in Serum Interleukin-6 (IL-6) Concentration
Time frame: Baseline and week 10
Change from Baseline in Serum Tumor Necrosis Factor-Alpha (TNF-alpha) Concentration
Time frame: Baseline and week 10
Change from Baseline in C-Reactive Protein (CRP) Concentration
Time frame: Baseline and week 10
Change from Baseline in Serum Brain-Derived Neurotrophic Factor (BDNF) Concentration
Time frame: Baseline and week 10
Change from Baseline in Serum Interleukin-1 Beta (IL-1beta) Concentration
Time frame: Baseline and week 10
Change from Baseline in Serum Interleukin-10 (IL-10) Concentration
Time frame: Baseline and week 10
Change from Baseline in Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline and week 10
Five Facet Mindfulness Questionnaire (FFMQ) Mean Item Score
Time frame: Baseline and week 10
Relative Abundance of Gut Microbial Taxa
Time frame: Baseline and week 10
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 7 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the findings reported in publications arising from this clinical trial may be made available upon reasonable request, subject to institutional and ethical approval.
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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 Short-Term Dynamic Psychotherapy and Mindfulness-Based Cognitive Therapy in people with Depressive Disorder, Treatment-Resistant, run by Korea University Ansan Hospital at 1 site in South Korea.
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 11 inclusion and 15 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 7 Oct 2026. 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 South Korea. 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 from Baseline in 17-Item Hamilton Depression Rating Scale (HAM-D) Total Score (time frame: Baseline and week 10). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026.