Completed

A Prospective Study on the Psychosocial Characteristics and Non-pharmacological Intervention of Patients With Treatment-resistant Depression

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What is being tested

Nurse-led cognitive-behavioral-based group intervention

Behavioral
Who is being recruted

Mental Disorders+1

+ Depressive Disorder

+ Mood Disorders

From 20 to 85 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: January 2018
See protocol details

Summary

Principal SponsorNational Taiwan University Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 9, 2018

Actual date on which the first participant was enrolled.

The three-year pioneering project began with observing the psychosocial characteristics and demographic profile of a group of TRD cohort, followed by validating the cultural meanings and recovery constructs of TRD through professional and lay focus groups in the first year. In the second to third year, we examined the effectiveness of a 8-week, nurse-led psychosocial intervention with group approach in a randomized control trial (RCT) compared to the controls receiving usual care with three follow-ups. Detailed psychiatric assessment and study interviews have been performed at baseline, 3, 6, and 9 months after the intervention by a senior psychiatrist and a research assistant using standardized operation forms.Structured measurements have been utilized to collect primary outcome variables of psychological distress, suicide risk and resilience as well as secondary outcome measures of quality of life, community reintegration level, perceived satisfaction, and main clinical variables (e.g., treatment adherence, service use such as ER/OPD attendance or hospitalization days). The control group receives usual care of pharmacological therapy provided by the psychiatrists in the Psychiatric Department of the study hospital in northern Taiwan.

Official TitleA Prospective Study on the Psychosocial Characteristics and Non-pharmacological Intervention of Patients With Treatment-resistant Depression
NCT03329391
Principal SponsorNational Taiwan University Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

46 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersDepressive DisorderMood DisordersDepressive Disorder, Treatment-Resistant

Criteria

6 inclusion criteria required to participate
Aged 20-85 ;

To be diagnosed with Major Depressive disorder or Bipolar II disorder;

Failed to respond to at least three weeks of two antidepressant trials ;

Able to communicate with Mandarin or Taiwanese ;

Show More Criteria

3 exclusion criteria prevent from participating
Unable to cooperate due to psychiatric symptom disturbance ;

Unwilling to provide most information in the questionnaire ;

Severely suicidal during study period

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The intervention group will receive a 8-week nurse-led psychosocial care group,which involve 90 minutes session every week.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Chia-Yi Wu

Taipei, TaiwanOpen Chia-Yi Wu in Google Maps
CompletedOne Study Center