Ignite Creation Date:
2024-05-06 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03329391
Status:
COMPLETED
Last Update Posted:
2021-05-10
First Post:
2017-10-12
Brief Title:
Psychosocial Characteristics and Non-pharmacological Intervention of Patients With Treatment-resistant Depression
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
A Prospective Study on the Psychosocial Characteristics and Non-pharmacological Intervention of Patients With Treatment-resistant Depression
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 psychiatrists 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 formsStructured 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 eg treatment adherence service use such as EROPD 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None