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NCT Number: NCT04503954

Efficacy of Chronic Disease Self-management Program in People With Schizophrenia

This was a randomized controlled behavioral intervention trial to assess the efficacy of investigating program of chronic disease self-management program in people on schizophrenia patients conditions of depression, activities of daily living, social function, work, and quality of life.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

20 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taipei University of Nursing and Health Sciences

Taipei, Wanhua Dist, 108306, Taiwan

About this study

Subjects were randomized to intervention group and control group. The primary outcome included eight measures, Stanford Self-Management Questionnaire, the Beck Depression Inventory-II, the Activities of Daily Living Rating Scale III, the Instrumental Activities of Daily Living Scale, the Participation Measure-3 Domains, 4 Dimensions, the Work Behavior Inventory, and the Schizophrenia-Quality of Life questionnaire.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of schizophrenia by DSM-5
  • age > 20 years
  • Stable mental symptoms
  • Willing to sign the subject's consent

Exclusion criteria

  • History of severe brain injury
  • Substance abuse
  • Diagnosis of intellectual developmental disorder
  • Unable to follow instructions

Treatment and study plan

Chronic disease self-management program

Other

The chronic disease self-management program is based on the self-efficacy theory for improving health behavior, by the solve health problem skill, health life style, emotion management skill, improve intention of health condition in people with chronic disease.

General psychiatric intervention

Other

General psychiatric intervention contains the activities in psychiatric center.

Primary outcomes

  1. Stanford Self-Management Questionnaire

    Time frame: 6 week

    The Stanford Self-Management Questionnaire is for Chronic Disease Self-management Program. A higher score indicates better self-management. Changes of the Canadian Occupational Performance Measure will be assessed at the 0 week, 6 weeks.

  2. Beck Depression Inventory-II,

    Time frame: 6 week

    Beck Depression Inventory-II assesses the person about depression. A higher score indicates more depression.

    Changes of Beck Depression Inventory-II will be assessed at the 0 week, 6 weeks.

  3. Activities of Daily Living Rating Scale III,

    Time frame: 6 week

    Activities of Daily Living Rating Scale III assesses instrumental activities of daily living. A higher score indicates better activities of daily living. Changes of Activities of Daily Living Rating Scale III will be assessed at the 0 week, 6 weeks.

  4. Instrumental Activities of Daily Living

    Time frame: 6 week

    Instrumental Activities of Daily Living assesses instrumental activities of daily living.

    A higher score indicates better instrumental activities of daily living. Changes of Instrumental Activities of Daily Living will be assessed at the 0 week, 6 weeks.

  5. Participation Measure-3 Domains Domains, 4 Dimensions

    Time frame: 6 week

    Participation Measure-3 Domains, 4 Dimensions assesses social participation. A higher score indicates better social participation. Changes of Participation Measure-3 Domains, 4 Dimensions will be assessed at the 0 week, 6 weeks.

  6. Work Behavior Inventory

    Time frame: 6 week

    Work Behavior Inventory assesses work behavior about chronic mental patients. A lower score indicates better work behavior. Changes of Work Behavior Inventory will be assessed at the 0 week, 6 weeks.

  7. Schizophrenia-Quality of Life questionnaire

    Time frame: 6 week

    Schizophrenia-Quality of Life questionnaire assesses schizophrenia quality of life. A higher score indicates better quality of life. Changes of Schizophrenia-Quality of Life questionnaire will be assessed at the 0 week, 6 weeks.

  8. Mini Mental State Examination-2nd edition

    Time frame: 6 week

    Mini Mental State Examination general cognitive function. A higher score indicates better general cognitive function.

    Changes of Mini Mental State Examination will be assessed at the 0 week, 6 weeks.

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 7, 2020
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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