Psychosocial Characteristics and Non-pharmacological Intervention of Patients With Treatment-resistant Depression
Primary Purpose
Treatment-resistant Depression
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Nurse-led cognitive-behavioral-based group intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Treatment-resistant Depression focused on measuring Psychosocial model,nursing intervention
Eligibility Criteria
Inclusion Criteria:
- 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 ;
- No severe or foreseeing cognitive impairment during study period judged by the co-PI;
- Willing to sign the informed consent.
Exclusion Criteria:
- Unable to cooperate due to psychiatric symptom disturbance ;
- Unwilling to provide most information in the questionnaire ;
- Severely suicidal during study period
Sites / Locations
- Chia-Yi Wu
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
The intervention group will receive a 8-week nurse-led psychosocial care group,which involve 90 minutes session every week.
The control group will receive usual care, which refers to the pharmacological therapy provided by psychiatrists in the Psychiatric Department.
Outcomes
Primary Outcome Measures
Change of score of the Brief Symptom Rating Scale(BSRS-5) for psychological distress level
The full scale contains five items of psychopathology: (1) anxiety; (2) depression; (3) hostility; (4) interpersonal sensitivity: inferiority; and (5) insomnia. An extra question "Do you have any suicide ideation?" is added at the end of the scale. It is a 5-item Likert scale (scores of 0 to 4) for assessment of psychological distress level by self-report of by interview. The rating of symptoms is based on a 5-point scale: 0, not at all; 1, a little bit; 2, moderately; 3, quite a bit; 4, extremely. Total score will be calculated based on the 5 questions with a maximum score of 20, where a higher score indicates higher level of psychological distress and poorer mental health status in the past week.
The change of score in 9-item Concise Mental Health Checklist (CMHC-9) for suicide risk assessment
The CMHC-9 is consisted of 9 items assessing psychopathgology (5 items) and suicide risk (4 items). The five item evaluated recent mental distress, lending the measurement from the BSRS-5, i.e., insomnia, anxiety, hostility, depression, and inferiority. The four items reflecting several key suicide risk factors, including lifetime suicide attempt, future suicide intent, alcohol or drug abuse history, and lack of social support. Each item was rated by 0/1, indicating the existence of each symptom, with a total score ranging from 0 to 9. The higher the score, the higher the risk of suicide. The cutoff at 4 points indicates a higher overall suicide risk among clinical or community population.
Change of score in Brief Resilience Coping Scale (BRCS) for tendencies to cope with stress
It is a 4-item measurement tool designed to assess the ability of an individual to cope with stress in a resilient fashion. The response consists of five options at which 1 means the statement "does not describe you at all" and 5 means "it describes you very well". The score is then added up.Among general public, the score of 4-13 indicates low resilient copers; 14-16 indicates medium resilient copers; and 17-20 indicates high resilient copers. However, the scores will undergo validation among a cohort of TRD patients in this study.
Secondary Outcome Measures
Community Integration Questionnaire-Revised (CIQ-R) for the participants' level of community integration
CIQ-R consists of four domains: home integration, social integration, productivity, andelectronic social networking score. The scale contains 18 items. The home integration subscale is made up of 5 items at which each item is scored from 0-2, where 2 indicates highest degree of integration. The Social Integration subscale consists 6 items with the same scoring method mentioned above. The productivity subscale consists of 4 questions with a total points of 7. The electronic social networking subscale consists of 3 questions with a total points of 6. Scores of these subscales are then added up as an overall CIQ score. Maximum score is 35, which represents maximum community reintegration.
EQ-5D questionnaire for quality of life
The EQ-5D is a self-completed questionnaire which contains five dimensions: mobility, self-care, usual activities, pain-discomfort, and anxiety-depression. The level of function in each dimension is classified into three degrees of disability, which is level 1(no disability), level 2(moderate disability), and level 3(severe disability). These responses will then generate a 5-digit descriptor ranging from 1-1-1-1-1 indicating perfect health to 3-3-3-3-3 indicating worth possible state. It is accompanied by a visual analogue scale (EQ-VAS) to assess perceived health conditions, which ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Full Information
NCT ID
NCT03329391
First Posted
October 12, 2017
Last Updated
May 6, 2021
Sponsor
National Taiwan University Hospital
Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03329391
Brief Title
Psychosocial Characteristics and Non-pharmacological Intervention of Patients With Treatment-resistant Depression
Official Title
A Prospective Study on the Psychosocial Characteristics and Non-pharmacological Intervention of Patients With Treatment-resistant Depression
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 9, 2018 (Actual)
Primary Completion Date
September 22, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pharmacotherapy and psychotherapy, effective management strategies for treatment-resistant depression are limited and yet to be developed. However, nursing interventions focusing on adherence enhancement, symptom reduction, and stress management may be strategic for a better disease management. This study aimed to define the rarely-studied concept of TRD under the cultural context of Taiwan and to identify new feasible and complementary treatment model from nursing perspectives. The project had established important basis on the descriptions of psychosocial features and need assessment of people with TRD over psychiatrist's validation. The findings also built up a cultural-specific non-pharmacological intervention module for effective TRD management in Taiwan. The nursing model of TRD management will further promote the development of integrative depression care in the future and complement current modalities, while providing important evidence-based information for future research and services.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment-resistant Depression
Keywords
Psychosocial model,nursing intervention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The intervention group will receive a 8-week nurse-led psychosocial care group,which involve 90 minutes session every week.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will receive usual care, which refers to the pharmacological therapy provided by psychiatrists in the Psychiatric Department.
Intervention Type
Behavioral
Intervention Name(s)
Nurse-led cognitive-behavioral-based group intervention
Intervention Description
The intervention focused on the following topics of symptom awareness(i.e. provision of literacy in depression and stress), stress management, lifestyle restructuring and emotional self-care. These topics have been integrated as four major domains for discussions in the eight-weekly sessions. Each session starts with open discussion for participants' daily concerns to activate group dynamics, followed by second part of domain-oriented discussions, and then the third part of session review and homework reminder.
Primary Outcome Measure Information:
Title
Change of score of the Brief Symptom Rating Scale(BSRS-5) for psychological distress level
Description
The full scale contains five items of psychopathology: (1) anxiety; (2) depression; (3) hostility; (4) interpersonal sensitivity: inferiority; and (5) insomnia. An extra question "Do you have any suicide ideation?" is added at the end of the scale. It is a 5-item Likert scale (scores of 0 to 4) for assessment of psychological distress level by self-report of by interview. The rating of symptoms is based on a 5-point scale: 0, not at all; 1, a little bit; 2, moderately; 3, quite a bit; 4, extremely. Total score will be calculated based on the 5 questions with a maximum score of 20, where a higher score indicates higher level of psychological distress and poorer mental health status in the past week.
Time Frame
Baseline assessment and follow up sessions on 3,6, and 9 months
Title
The change of score in 9-item Concise Mental Health Checklist (CMHC-9) for suicide risk assessment
Description
The CMHC-9 is consisted of 9 items assessing psychopathgology (5 items) and suicide risk (4 items). The five item evaluated recent mental distress, lending the measurement from the BSRS-5, i.e., insomnia, anxiety, hostility, depression, and inferiority. The four items reflecting several key suicide risk factors, including lifetime suicide attempt, future suicide intent, alcohol or drug abuse history, and lack of social support. Each item was rated by 0/1, indicating the existence of each symptom, with a total score ranging from 0 to 9. The higher the score, the higher the risk of suicide. The cutoff at 4 points indicates a higher overall suicide risk among clinical or community population.
Time Frame
Baseline assessment and follow-up session on the 9th month
Title
Change of score in Brief Resilience Coping Scale (BRCS) for tendencies to cope with stress
Description
It is a 4-item measurement tool designed to assess the ability of an individual to cope with stress in a resilient fashion. The response consists of five options at which 1 means the statement "does not describe you at all" and 5 means "it describes you very well". The score is then added up.Among general public, the score of 4-13 indicates low resilient copers; 14-16 indicates medium resilient copers; and 17-20 indicates high resilient copers. However, the scores will undergo validation among a cohort of TRD patients in this study.
Time Frame
Baseline assessment and follow up sessions on 3,6, and 9 months
Secondary Outcome Measure Information:
Title
Community Integration Questionnaire-Revised (CIQ-R) for the participants' level of community integration
Description
CIQ-R consists of four domains: home integration, social integration, productivity, andelectronic social networking score. The scale contains 18 items. The home integration subscale is made up of 5 items at which each item is scored from 0-2, where 2 indicates highest degree of integration. The Social Integration subscale consists 6 items with the same scoring method mentioned above. The productivity subscale consists of 4 questions with a total points of 7. The electronic social networking subscale consists of 3 questions with a total points of 6. Scores of these subscales are then added up as an overall CIQ score. Maximum score is 35, which represents maximum community reintegration.
Time Frame
Follow up sessions on 3, 6, and 9 months
Title
EQ-5D questionnaire for quality of life
Description
The EQ-5D is a self-completed questionnaire which contains five dimensions: mobility, self-care, usual activities, pain-discomfort, and anxiety-depression. The level of function in each dimension is classified into three degrees of disability, which is level 1(no disability), level 2(moderate disability), and level 3(severe disability). These responses will then generate a 5-digit descriptor ranging from 1-1-1-1-1 indicating perfect health to 3-3-3-3-3 indicating worth possible state. It is accompanied by a visual analogue scale (EQ-VAS) to assess perceived health conditions, which ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time Frame
Follow up sessions on 3, 6, and 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 ;
No severe or foreseeing cognitive impairment during study period judged by the co-PI;
Willing to sign the informed consent.
Exclusion Criteria:
Unable to cooperate due to psychiatric symptom disturbance ;
Unwilling to provide most information in the questionnaire ;
Severely suicidal during study period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-yi Wu, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chia-Yi Wu
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Links:
URL
https://scholars.lib.ntu.edu.tw/cris/rp/rp06469/information.html
Description
Researcher's profile
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Psychosocial Characteristics and Non-pharmacological Intervention of Patients With Treatment-resistant Depression
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