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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03967431
Other study ID # IRB1070910-02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 20, 2018
Est. completion date July 18, 2019

Study information

Verified date July 2019
Source National Yang Ming University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date July 18, 2019
Est. primary completion date July 12, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 64 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Narrative Enhancement and Cognitive Therapy (NECT)
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.

Locations

Country Name City State
Taiwan National Yang-Ming University Taipei City

Sponsors (1)

Lead Sponsor Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
Primary 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. For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
Secondary 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. For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
Secondary 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. For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
Secondary 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. For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
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