Psychosocial Characteristics and Non-pharmacological Intervention of Patients With Treatment-resistant Depression
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|ClinicalTrials.gov Identifier: NCT03329391|
Recruitment Status : Not yet recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Treatment-resistant Depression||Behavioral: Nurse-led psychosocial care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Prospective Study on the Psychosocial Characteristics and Non-pharmacological Intervention of Patients With Treatment-resistant Depression|
|Estimated Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||January 2020|
Experimental: Intervention Group
The intervention group will receive a 6-week nurse-led psychosocial care group,which involve 90 minutes session every week.
Behavioral: Nurse-led psychosocial care
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 six-weekly discussions. 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.
No Intervention: Control Group
The control group will receive usual care, which refers to the pharmacological therapy provided by psychiatrists in the Psychiatric Department.
- Change of score of the Brief Symptom Rating Scale(BSRS-5) for psychological distress level [ Time Frame: Baseline assessment and follow up sessions on 3,6, and 9 months ]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 poorer mental health.
- Community Integration Questionnaire (CIQ) for participants' reintegration progress [ Time Frame: Follow up sessions on 3, 6, and 9 months ]CIQ consists of three domains: home integration, social integration and productivity. The scale contains 15 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 subcale consists of 4 questions with a total points of 7. Scores of these subscales are then added up as an overall CIQ score. Maximum score is 29, which represents maximum community reintegration.
- Change of score in Brief Resilience Coping Scale (BRCS) for tendencies to cope with stress [ Time Frame: Baseline assessment and follow up sessions on 3, 6, and 9 months ]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. 4-13 indicates low resilient copers; 14-16 indicates medium resilient copers; and 17-20 indicates high resilient copers.
- The change of score in 9-item Concise Mental Health Checklist (CMHC-9) for suicide risk assessment [ Time Frame: Baseline assessment and last follow up session ]It is consisted of two subscales, which are the Brief Symptom Rating Scale (BSRS-5R) and Chinese SAD PERSONS Scale (CSPS) measuring psychopathology and key suicide risk factors respectively. The BSRS-5R consists of 5 items same as the BSRS-5, only that the answer is modified to yes/no responses instead of 5-point Likert Scale. The responses are coded into 1/0 respectively and the total score ranges from 0 to 5. The CSPS is a 9-item self-reported checklist design to evaluate suicide risk and assists decisions about hospitalization for ED patients. It contains three demographic items and six suicide risk items. The coding of the score is same as the BSRS-5R. After deleting three demographic variables and redundant items of delusional thought and severe suicide attempt, the two subscales are merged together, with a total score ranging from 0 to 9.
- EQ-5D questionnaire for quality of life. [ Time Frame: Follow up sessions on 3, 6, and 9 months ]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 11111 indicating perfect health to 33333 indicating worth possible state. It is accompanied by a visual analogue scale (EQ-VAS) which ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
- MacArthur Scale of Subjective Social Status [ Time Frame: Baseline assessment ]The scale contains a ladder illustrations, ranging from 1 to 10. There are two versions of ladder, the society ladder is a global measure of subjective social status and demonstrate an individual's place in the social hierarchy; the community ladder assesses how individual see themselves in the ladder considering the community they are living in. Those with higher living standards will be on top of ladder and vice versa.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03329391
|Contact: Chia-yi Wu, PhD||886-2-23123456 ext email@example.com|
|Taipei, Taiwan, 100|
|Principal Investigator:||Chia-yi Wu, PhD||National Taiwan University Hospital|