Clinical trial NCT03329391: 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
Overall status: COMPLETED
Phase: NA
Conditions: Treatment-resistant Depression
Keywords: Psychosocial model,nursing intervention
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Shin Kong Wu Ho-Su Memorial Hospital
First posted: 2017-11-06
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Aged 20-85 ;
2. To be diagnosed with Major Depressive disorder or Bipolar II disorder;
3. Failed to respond to at least three weeks of two antidepressant trials ;
4. Able to communicate with Mandarin or Taiwanese ;
5. No severe or foreseeing cognitive impairment during study period judged by the co-PI；
6. Willing to sign the informed consent.

Exclusion Criteria:

1. Unable to cooperate due to psychiatric symptom disturbance ;
2. Unwilling to provide most information in the questionnaire ;
3. Severely suicidal during study period

Primary outcomes:
measure: Change of score of the Brief Symptom Rating Scale(BSRS-5) for psychological distress level
timeFrame: Baseline assessment and follow up sessions on 3,6, and 9 months
measure: The change of score in 9-item Concise Mental Health Checklist (CMHC-9) for suicide risk assessment
timeFrame: Baseline assessment and follow-up session on the 9th month
measure: Change of score in Brief Resilience Coping Scale (BRCS) for tendencies to cope with stress
timeFrame: Baseline assessment and follow up sessions on 3,6, and 9 months
Secondary outcomes:
measure: Community Integration Questionnaire-Revised (CIQ-R) for the participants' level of community integration
timeFrame: Follow up sessions on 3, 6, and 9 months
measure: EQ-5D questionnaire for quality of life
timeFrame: Follow up sessions on 3, 6, and 9 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chia-Yi Wu
Study officials:
affiliation: National Taiwan University Hospital
name: Chia-yi Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: