SchizophreniaNCT03967431
Effects of Narrative Enhancement and Cognitive Therapy (NECT) on Self-stigma in Patients With Schizophrenia
A study testing Narrative Enhancement and Cognitive Therapy (NECT) in people with Schizophrenia, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Narrative Enhancement and Cognitive Therapy (NECT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Oct 2018to 18 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Narrative Enhancement and Cognitive Therapy (NECT)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Enhancement and Cognitive Therapy (NECT)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Narrative Enhancement and Cognitive Therapy group | Experimental | The patients in the experimental group received narrative enhancement and cognitive therapy which contains 20 times group meetings. Receives: Other: Narrative Enhancement and Cognitive Therapy (NECT) |
| Control group | No intervention | The patients in the control group received routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
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.
Measured: For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
Secondary outcomes (3)
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.
Measured: For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
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.
Measured: For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
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.
Measured: For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start20 Oct 2018
- Primary completion12 Jul 2019
- Study completion18 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants were divided into experimental and control groups through block randomization.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chiu-Yueh Yang, Ph.D., Study chair, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967431
- Sponsor's protocol ID
- IRB1070910-02
- Status last verified
- Jul 2019
- First submitted
- 27 May 2019
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Narrative Enhancement and Cognitive Therapy (NECT) on Self-stigma in Patients With Schizophrenia: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03967431
- Acronym / sponsor ID
- IRB1070910-02
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 20 Oct 2018 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The participants were divided into experimental and control groups through block randomization.
| Arm | Type | Receives |
|---|---|---|
| Narrative Enhancement and Cognitive Therapy group | Experimental | Other: Narrative Enhancement and Cognitive Therapy (NECT)The patients in the experimental group received narrative enhancement and cognitive therapy which contains 20 times group meetings. |
| Control group | No intervention | –The patients in the control group received routine care. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Narrative Enhancement and Cognitive Therapy group |
Primary outcome
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)
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
Time frame: For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
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.
3 secondary outcomes
Beck Depression Inventory (BDI-II)
Time frame: For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
Herth Hope Index (HHI)
Time frame: For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
Rosenberg self-esteem scale
Time frame: For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiu-Yueh Yang, Ph.D. study chair
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative Enhancement and Cognitive Therapy (NECT) in people with Schizophrenia, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020; AzTrials last refreshed its copy on 7 Nov 2026.