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Effects of Narrative Enhancement and Cognitive Therapy (NECT) on Self-stigma in Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Narrative Enhancement and Cognitive Therapy (NECT)
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • People with Schizophrenia for more than two years.
  • The age is between 20(included) and 64(included).
  • Can communicate with Mandarin or Taiwanese.
  • The score of the Mini-Mental State Examination (MMSE) is above 24(included).
  • The score of the Positive and Negative Syndrome Scale(PANSS) is below 60(included).
  • People are willing to participate in this study, can read and know the consent and can sign on the consent by their own.

Exclusion Criteria:

  • Exclude people with a personality disorder, brain injury, cognitive impairment, Intellectual Developmental Disorder or substance use disorder.
  • people who are not willing to sign the consent.
  • people can not read.
  • people can not communicate with Mandarin or Taiwanese.

Sites / Locations

  • National Yang-Ming University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Narrative Enhancement and Cognitive Therapy group

Control group

Arm Description

The patients in the experimental group received narrative enhancement and cognitive therapy which contains 20 times group meetings.

The patients in the control group received routine care.

Outcomes

Primary Outcome Measures

The Internalized Stigma of Mental Illness Scale (ISMIS)
To measure internalized stigma. There are five sub-scales in ISMIS, including Alienation(6 items), Stereotype Experience(7 items), Discrimination Experience(5 items), Social Withdrawal(6 items) and Stigma Resistance(5 items). There are 29 items in this scale. Using Likert scale to rate each item (1=Strongly disagree, 2=disagree, 3=agree, 4=strongly agree) and higher score means higher internalized stigma.
The Discrimination and Stigma Scale
To know the experiences of discrimination and stigma. There are four sub-scales in DISC, including Unfair Treatment, Stopping Self, Overcoming Stigma and Positive Treatment. These four sub-scales are independent. Using four point to rate each item(0=not at all, 1=a little, 2=Moderately, 3=A lot) or choose "Not applicable" if the item is not applicable for the subject.

Secondary Outcome Measures

Beck Depression Inventory (BDI-II)
To know the level of depressive symptoms.There are 21 items in BDI-II. Using 0 to 3 to rate each item. The higher score a participant get, a higher depressive symptoms a participant has.
Herth Hope Index (HHI)
To measure the level of hope. There are 12 items in this scale. Using Likert scale to rate each item (1=Strongly disagree, 2=disagree, 3=agree, 4=strongly agree) and higher score means higher level of hope.
Rosenberg self-esteem scale
To measure the level of self-esteem.There are 10 items in this scale. Using Likert scale to rate each item (1=Strongly disagree, 2=disagree, 3=agree, 4=strongly agree) and higher score means higher level of self-esteem.

Full Information

First Posted
May 27, 2019
Last Updated
August 16, 2020
Sponsor
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT03967431
Brief Title
Effects of Narrative Enhancement and Cognitive Therapy (NECT) on Self-stigma in Patients With Schizophrenia
Official Title
Effects of Narrative Enhancement and Cognitive Therapy (NECT) on Self-stigma in Patients With Schizophrenia: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 20, 2018 (Actual)
Primary Completion Date
July 12, 2019 (Actual)
Study Completion Date
July 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to explore the effect of narrative enhancement and cognitive therapy in improving self-stigma, self-esteem, depression and hope of patients with chronic schizophrenia.
Detailed Description
86 participants with chronic schizophrenia in two different hospitals in northern Taiwan were recruited in this study. All participants were randomized into experimental and control groups through block randomization. After randomization, the participants in control group received routine care and the others in experimental group received Narrative Enhancement and Cognitive Therapy(NECT) which contains 20 times group meetings. The research tools include demographic data, the Internalized Stigma of Mental Illness Scale (ISMIS), the Discrimination and Stigma Scale (DISC), Rosenberg self-Esteem scale (RSES), Beck Depression Inventory (BDI-II) and Herth Hope Index (HHI). The questionnaires were collected for three times, including before the intervention, 12 weeks after intervention, and after the end of intervention. The collected data were analyzed by IBM SPSS 24.0 statistical software. The descriptive statistics include mean, standard deviation, minimum, maximum, frequency distribution, and percentages; the Generalized estimating equations (GEE) were used to explore the effect of Narrative Enhancement and Cognitive Therapy on self-stigma, self-esteem, depressive symptoms and hope in patients with schizophrenia after controlling demographic data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The participants were divided into experimental and control groups through block randomization.
Masking
Participant
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Narrative Enhancement and Cognitive Therapy group
Arm Type
Experimental
Arm Description
The patients in the experimental group received narrative enhancement and cognitive therapy which contains 20 times group meetings.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The patients in the control group received routine care.
Intervention Type
Other
Intervention Name(s)
Narrative Enhancement and Cognitive Therapy (NECT)
Intervention Description
Narrative Enhancement and Cognitive Therapy includes two introduction meetings, three psychoeducation meetings, seven cognitive restructuring meetings, seven narrative enhancement meetings and one summing up meeting.
Primary Outcome Measure Information:
Title
The Internalized Stigma of Mental Illness Scale (ISMIS)
Description
To measure internalized stigma. There are five sub-scales in ISMIS, including Alienation(6 items), Stereotype Experience(7 items), Discrimination Experience(5 items), Social Withdrawal(6 items) and Stigma Resistance(5 items). There are 29 items in this scale. Using Likert scale to rate each item (1=Strongly disagree, 2=disagree, 3=agree, 4=strongly agree) and higher score means higher internalized stigma.
Time Frame
For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
Title
The Discrimination and Stigma Scale
Description
To know the experiences of discrimination and stigma. There are four sub-scales in DISC, including Unfair Treatment, Stopping Self, Overcoming Stigma and Positive Treatment. These four sub-scales are independent. Using four point to rate each item(0=not at all, 1=a little, 2=Moderately, 3=A lot) or choose "Not applicable" if the item is not applicable for the subject.
Time Frame
For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
Secondary Outcome Measure Information:
Title
Beck Depression Inventory (BDI-II)
Description
To know the level of depressive symptoms.There are 21 items in BDI-II. Using 0 to 3 to rate each item. The higher score a participant get, a higher depressive symptoms a participant has.
Time Frame
For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
Title
Herth Hope Index (HHI)
Description
To measure the level of hope. There are 12 items in this scale. Using Likert scale to rate each item (1=Strongly disagree, 2=disagree, 3=agree, 4=strongly agree) and higher score means higher level of hope.
Time Frame
For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
Title
Rosenberg self-esteem scale
Description
To measure the level of self-esteem.There are 10 items in this scale. Using Likert scale to rate each item (1=Strongly disagree, 2=disagree, 3=agree, 4=strongly agree) and higher score means higher level of self-esteem.
Time Frame
For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: People with Schizophrenia for more than two years. The age is between 20(included) and 64(included). Can communicate with Mandarin or Taiwanese. The score of the Mini-Mental State Examination (MMSE) is above 24(included). The score of the Positive and Negative Syndrome Scale(PANSS) is below 60(included). People are willing to participate in this study, can read and know the consent and can sign on the consent by their own. Exclusion Criteria: Exclude people with a personality disorder, brain injury, cognitive impairment, Intellectual Developmental Disorder or substance use disorder. people who are not willing to sign the consent. people can not read. people can not communicate with Mandarin or Taiwanese.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiu-Yueh Yang, Ph.D.
Organizational Affiliation
National Yang Ming University
Official's Role
Study Chair
Facility Information:
Facility Name
National Yang-Ming University
City
Taipei City
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Narrative Enhancement and Cognitive Therapy (NECT) on Self-stigma in Patients With Schizophrenia

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