- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03967431
Effects of Narrative Enhancement and Cognitive Therapy (NECT) on Self-stigma in Patients With Schizophrenia
August 16, 2020 updated by: National Yang Ming University
Effects of Narrative Enhancement and Cognitive Therapy (NECT) on Self-stigma in Patients With Schizophrenia: A Randomized Controlled Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
86
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei City, Taiwan
- National Yang-Ming University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 64 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Narrative Enhancement and Cognitive Therapy group
The patients in the experimental group received narrative enhancement and cognitive therapy which contains 20 times group meetings.
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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.
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NO_INTERVENTION: Control group
The patients in the control group received routine care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Internalized Stigma of Mental Illness Scale (ISMIS)
Time Frame: For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
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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.
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For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
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The Discrimination and Stigma Scale
Time Frame: For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
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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.
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For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck Depression Inventory (BDI-II)
Time Frame: For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
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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.
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For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
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Herth Hope Index (HHI)
Time Frame: For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
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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.
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For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
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Rosenberg self-esteem scale
Time Frame: For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
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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.
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For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Chiu-Yueh Yang, Ph.D., National Yang Ming University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 20, 2018
Primary Completion (ACTUAL)
July 12, 2019
Study Completion (ACTUAL)
July 18, 2019
Study Registration Dates
First Submitted
May 27, 2019
First Submitted That Met QC Criteria
May 27, 2019
First Posted (ACTUAL)
May 30, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 18, 2020
Last Update Submitted That Met QC Criteria
August 16, 2020
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB1070910-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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