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

NCT03329391 | Completed

• 1 other identifier: 201612198RINB
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment-resistant Depression

Keywords

Psychosocial model,nursing intervention

Outcome Measures

Primary Outcomes (3)

• Change of score of the Brief Symptom Rating Scale(BSRS-5) for psychological distress level

  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 higher level of psychological distress and poorer mental health status in the past week.

  Baseline assessment and follow up sessions on 3,6, and 9 months

• The change of score in 9-item Concise Mental Health Checklist (CMHC-9) for suicide risk assessment

  The CMHC-9 is consisted of 9 items assessing psychopathgology (5 items) and suicide risk (4 items). The five item evaluated recent mental distress, lending the measurement from the BSRS-5, i.e., insomnia, anxiety, hostility, depression, and inferiority. The four items reflecting several key suicide risk factors, including lifetime suicide attempt, future suicide intent, alcohol or drug abuse history, and lack of social support. Each item was rated by 0/1, indicating the existence of each symptom, with a total score ranging from 0 to 9. The higher the score, the higher the risk of suicide. The cutoff at 4 points indicates a higher overall suicide risk among clinical or community population.

  Baseline assessment and follow-up session on the 9th month

• Change of score in Brief Resilience Coping Scale (BRCS) for tendencies to cope with stress

  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.Among general public, the score of 4-13 indicates low resilient copers; 14-16 indicates medium resilient copers; and 17-20 indicates high resilient copers. However, the scores will undergo validation among a cohort of TRD patients in this study.

  Baseline assessment and follow up sessions on 3,6, and 9 months

Secondary Outcomes (2)

• Community Integration Questionnaire-Revised (CIQ-R) for the participants' level of community integration

  Follow up sessions on 3, 6, and 9 months

• EQ-5D questionnaire for quality of life

  Follow up sessions on 3, 6, and 9 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Behavioral: Nurse-led cognitive-behavioral-based group intervention

Control Group

NO INTERVENTION

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

Interventions

Nurse-led cognitive-behavioral-based group intervention 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.

Intervention Group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Shin Kong Wu Ho-Su Memorial Hospital: collaborator

Study Sites (1)

Chia-Yi Wu

Taipei, 100, Taiwan

Location

Related Links

• Researcher's profile

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Chia-yi Wu, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: November 6, 2017
• Study Start: January 9, 2018
• Primary Completion: September 22, 2020
• Study Completion: October 30, 2020
• Last Updated: May 10, 2021

Record last verified: 2020-06

Locations

TW (1)