Psychosocial Characteristics and Non-pharmacological Intervention of Patients With Treatment-resistant Depression

NCT ID: NCT03329391

Last Updated: 2021-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-09
• Study Completion Date: 2020-10-30

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.

Conditions

Treatment-resistant Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group

The intervention group will receive a 8-week nurse-led psychosocial care group,which involve 90 minutes session every week.

Group Type: EXPERIMENTAL

Nurse-led cognitive-behavioral-based group intervention

Intervention Type: BEHAVIORAL

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.

Control Group

The control group will receive usual care, which refers to the pharmacological therapy provided by psychiatrists in the Psychiatric Department.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nurse-led cognitive-behavioral-based group intervention

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shin Kong Wu Ho-Su Memorial Hospital

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chia-yi Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

Chia-Yi Wu

Taipei, , Taiwan

Countries

Taiwan

Related Links

https://scholars.lib.ntu.edu.tw/cris/rp/rp06469/information.html

Researcher's profile

Other Identifiers

201612198RINB

Identifier Type: -

Identifier Source: org_study_id