ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03329391
Recruitment Status : Not yet recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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 aims to define the rarely-studied concept of TRD under the cultural context of Taiwan and to identify new feasible treatment model from nursing perspectives. The project will establish important basis on the descriptions of psychosocial features and need assessment of people with TRD under experienced psychiatric team validation, and also build up a cultural-specific non-pharmacological intervention module for effective TRD management in Taiwan. The nursing model of TRD management will promote the development of integrative depression care in the future and complement current modalities, while providing important evidence-based information for further research and services.

Condition or disease Intervention/treatment Phase
Treatment-resistant Depression Behavioral: Nurse-led psychosocial care Not Applicable

Detailed Description:
The three-year pioneering project will begin with observing the psychosocial characteristics and demographic profile of a group of patients with depressive disorders and a sub-group of TRD cohort, followed by validating the cultural meanings and recovery constructs of TRD through professional and lay focus groups. In the second to third year, we will examine the effectiveness of a 6-week, nurse-led psychosocial intervention with group approach in a randomized control trial (RCT) compared to the controls receiving usual care with follow-ups. Detailed psychiatric assessment and study interviews will be 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 will be 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Prospective Study on the Psychosocial Characteristics and Non-pharmacological Intervention of Patients With Treatment-resistant Depression
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
The intervention group will receive a 6-week nurse-led psychosocial care group,which involve 90 minutes session every week.
Behavioral: Nurse-led psychosocial care
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 six-weekly discussions. 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.

No Intervention: Control Group
The control group will receive usual care, which refers to the pharmacological therapy provided by psychiatrists in the Psychiatric Department.



Primary Outcome Measures :
  1. Change of score of the Brief Symptom Rating Scale(BSRS-5) for psychological distress level [ Time Frame: Baseline assessment and follow up sessions on 3,6, and 9 months ]
    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 poorer mental health.


Secondary Outcome Measures :
  1. Community Integration Questionnaire (CIQ) for participants' reintegration progress [ Time Frame: Follow up sessions on 3, 6, and 9 months ]
    CIQ consists of three domains: home integration, social integration and productivity. The scale contains 15 items. The home integration subscale is made up of 5 items at which each item is scored from 0-2, where 2 indicates highest degree of integration. The Social Integration subscale consists 6 items with the same scoring method mentioned above. The productivity subcale consists of 4 questions with a total points of 7. Scores of these subscales are then added up as an overall CIQ score. Maximum score is 29, which represents maximum community reintegration.

  2. Change of score in Brief Resilience Coping Scale (BRCS) for tendencies to cope with stress [ Time Frame: Baseline assessment and follow up sessions on 3, 6, and 9 months ]
    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. 4-13 indicates low resilient copers; 14-16 indicates medium resilient copers; and 17-20 indicates high resilient copers.

  3. The change of score in 9-item Concise Mental Health Checklist (CMHC-9) for suicide risk assessment [ Time Frame: Baseline assessment and last follow up session ]
    It is consisted of two subscales, which are the Brief Symptom Rating Scale (BSRS-5R) and Chinese SAD PERSONS Scale (CSPS) measuring psychopathology and key suicide risk factors respectively. The BSRS-5R consists of 5 items same as the BSRS-5, only that the answer is modified to yes/no responses instead of 5-point Likert Scale. The responses are coded into 1/0 respectively and the total score ranges from 0 to 5. The CSPS is a 9-item self-reported checklist design to evaluate suicide risk and assists decisions about hospitalization for ED patients. It contains three demographic items and six suicide risk items. The coding of the score is same as the BSRS-5R. After deleting three demographic variables and redundant items of delusional thought and severe suicide attempt, the two subscales are merged together, with a total score ranging from 0 to 9.

  4. EQ-5D questionnaire for quality of life. [ Time Frame: Follow up sessions on 3, 6, and 9 months ]
    The EQ-5D is a self-completed questionnaire which contains five dimensions: mobility, self-care, usual activities, pain-discomfort, and anxiety-depression. The level of function in each dimension is classified into three degrees of disability, which is level 1(no disability), level 2(moderate disability), and level 3(severe disability). These responses will then generate a 5-digit descriptor ranging from 11111 indicating perfect health to 33333 indicating worth possible state. It is accompanied by a visual analogue scale (EQ-VAS) which ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).

  5. MacArthur Scale of Subjective Social Status [ Time Frame: Baseline assessment ]
    The scale contains a ladder illustrations, ranging from 1 to 10. There are two versions of ladder, the society ladder is a global measure of subjective social status and demonstrate an individual's place in the social hierarchy; the community ladder assesses how individual see themselves in the ladder considering the community they are living in. Those with higher living standards will be on top of ladder and vice versa.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 18-64 ;
  2. Able to communicate with Mandarin or Taiwanese ;
  3. No severe or foreseeing cognitive impairment during study period judged by the co-PI;
  4. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03329391


Contacts
Contact: Chia-yi Wu, PhD 886-2-23123456 ext 88430 jennycyw@ntu.edu.tw

Locations
Taiwan
Chia-Yi Wu
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chia-yi Wu, PhD National Taiwan University Hospital

Additional Information:
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03329391     History of Changes
Other Study ID Numbers: 201612198RINB
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Taiwan University Hospital:
Psychosocial model,nursing intervention

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders