NCT03967431

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2019

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2019

Completed
Last Updated

August 18, 2020

Status Verified

July 1, 2019

Enrollment Period

9 months

First QC Date

May 27, 2019

Last Update Submit

August 16, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (3)

  • Beck Depression Inventory (BDI-II)

    For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)

  • Herth Hope Index (HHI)

    For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)

  • Rosenberg self-esteem scale

    For two groups at baseline(T0), at 12th week(T1) and at 20th week(T2)

Study Arms (2)

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.

Other: Narrative Enhancement and Cognitive Therapy (NECT)

Control group

NO INTERVENTION

The patients in the control group received routine care.

Interventions

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.

Narrative Enhancement and Cognitive Therapy group

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang-Ming University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Chiu-Yueh Yang, Ph.D.

    National Yang Ming Chiao Tung University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The participants were divided into experimental and control groups through block randomization.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2019

First Posted

May 30, 2019

Study Start

October 20, 2018

Primary Completion

July 12, 2019

Study Completion

July 18, 2019

Last Updated

August 18, 2020

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations