Psychosocial Characteristics and Non-pharmacological Intervention of Patients With Treatment-resistant Depression
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About
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.
Full 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.
Enrollment
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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
Trial design
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Interventional model
Masking
46 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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