NCT04040998

Brief Summary

This study aimed to investigate the effects of compensatory cognitive training plus treatment as usual (CCT+TAU) versus treatment as usual (TAU) on on self-esteem, self-efficacy, quality of life, and self-stigma for schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jan 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

January 5, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
Last Updated

August 1, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

July 26, 2019

Last Update Submit

July 30, 2019

Conditions

Schizophrenia

Keywords

schizophreniacompensatory cognitive traininggeneralized estimating equationpsychosocial correlatesself-stigma

Outcome Measures

Primary Outcomes (4)

  • Change scores of Rosenberg Self-Esteem Scale (RSES)

    The Chinese version of Rosenberg Self-Esteem Scale (RSES) was implemented as self-esteem measures. The total score ranged from 10 to 40, with higher scores reflecting higher levels of self-esteem.

    3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention

  • Change scores of General Self-Efficacy Scale (GSES)

    The Chinese version of General Self-Efficacy Scale (GSES) consisted of 10 items, assessing optimistic self-beliefs to cope with a variety of difficult demands in life. The total score ranged from 10 to 40, with higher scores indicating more self-efficacy.

    3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention

  • Change scores of Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4)

    The Chinese version of Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) was administered to measure subjective quality of life. The total scores ranged from 33-165, with higher scores indicating comparatively lower quality of life.

    3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention

  • Change scores of Internalized Stigma of Mental Illness (ISMIS)

    The Chinese version of Internalized Stigma of Mental Illness (ISMIS) consists of 29 items incorporated in five domains: alienation, stereotype endorsement, discrimination experience, social withdrawal, and stigma resistance. The total scores range from 29-116. The higher scores on the ISMIS indicates more severe internalized stigmatization.

    3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention

Study Arms (2)

CCT+TAU group

EXPERIMENTAL

The participants in CCT+TAU group received compensatory cognitive training plus treatment as usual. The CCT intervention consisted of two 50-minute sessions each week for 10 weeks

Behavioral: Compensatory Cognitive Training

TAU group

NO INTERVENTION

The participants in TAU group received usual treatment at the same time as CCT+TAU group.

Interventions

Compensatory Cognitive TrainingBEHAVIORAL

Teach the participants compensatory cognitive skills and strategies

CCT+TAU group

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of schizophrenia, based on the ICD-10 diagnostic criteria for research (World Health Organization, 1992)
  • age from 20 to 65
  • attending day care center regularly for at least 3 months
  • taking stable dose of medication for at least 3 months

You may not qualify if:

  • comorbid autism spectrum disorder
  • comorbid mental retardation
  • lacking the reading and writing skills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taoyuan Psychiatric Center Ministry of Health and Welfare

Taoyuan District, 330, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Occupational Therapist

Study Record Dates

First Submitted

July 26, 2019

First Posted

August 1, 2019

Study Start

January 5, 2018

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

August 1, 2019

Record last verified: 2019-07

Locations

TW(1)