Early Detection and Intervention for Women At-risk of Psychosis
2 other identifiers
interventional
160
1 country
1
Brief Summary
This study aims to examine the effectiveness of the cognitive behavioral therapy in preventing the conversion of psychosis in a sample of individuals at-risk for psychosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2018
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
June 14, 2018
CompletedStudy Start
First participant enrolled
November 15, 2018
CompletedFirst Posted
Study publicly available on registry
November 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2023
CompletedApril 20, 2021
April 1, 2021
2.8 years
June 14, 2018
April 18, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Functioning: Measured by Social and Occupational Functioning Assessment Scale (SOFAS)
Measured by Social and Occupational Functioning Assessment Scale (SOFAS). The SOFAS is an observer rating scale. Ratings should be based on subject's behavior during the last 1 month. The score ranges from 0-100. A higher score represents a better outcome.
Changes from baseline to immediate, 6- and 12-month post-intervention
Functioning: Measured by Role Functioning Scale (RFS)
Measured by Role Functioning Scale (RFS). The RFS is comprised of four single rating scaled for evaluating the functioning of individuals in specified areas of everyday life. The four role functions assessed are:(1)Working: productivity, (2) Independent living and self care, (3) Immediate social network relationships, and (4) Extended social network relationship. The values on each of the four scales range from 1 (minimal level of role functioning), to 7 (hypothetically optimal level of role functioning). Each of the seven points on the scales is accompanied by a behaviorally defined description.
Changes from baseline to immediate, 6- and 12-month post-intervention
Conversion of psychosis
Proportion of subject that convert from at-risk state to psychosis
12-month post-intervention
Secondary Outcomes (4)
Positive psychotic symptoms
Immediate, 6- and 12-month post-intervention
Beliefs about the auditory hallucination
Immediate, 6- and 12-month post-intervention
Depressive symptoms
Immediate, 6- and 12-month post-intervention
Social anxiety :Measured by Liebowitz Social Anxiety Scale (LSAS)
Immediate, 6- and 12-month post-intervention
Study Arms (2)
CBT group
EXPERIMENTALThis intervention aims for distress reduction, symptom coping, and life quality enhancement. It is a gender-specific CBT tailor-made for the at-risk population. The intervention is delivered by a registered clinical psychologist.
Psychoeducation group
ACTIVE COMPARATORThe content of the psycho-education program will be related to healthy living content and mental health knowledge, such as food hygiene, psychological well-being, knowledge about psychosis and common mental disorder and food nutrition. In addition, a weekly call to remind the subject about healthy living will also be provided to the subjects. The intervention is delivered by a registered social worker.
Interventions
A total of 8 CBT sessions will be provided to the participants, each session lasts for approximately 1.5 hour.
A total of 8 psychoeducation sessions will be provided to the participants, each session lasts for approximately 1.5 hour.
Eligibility Criteria
You may qualify if:
- women of age 18-64
- at-risk mental state as defined by the Comprehensive Assessment of At-Risk Mental States (CAARMS)
- with an informed consent
- able to understand Cantonese and read/write Chinese
You may not qualify if:
- those mental conditions that requires other treatment priorities (e.g., suicidal risk, substance abuse, current or past episodes of psychotic disorder, personality disorders)
- those medical conditions that severely limits participation, comprehension, or adherence to the treatment (e.g., epilepsy, dementia, terminal medical illness);
- those who are receiving structured psychotherapy or counselling
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Hong Kong
Hong Kong, 0000, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Yu Hai Chen, MD
The University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chi-li Pao Foundation Professor of Psychiatry; Chair Professor in Psychiatry; Head, Department of Psychiatry
Study Record Dates
First Submitted
June 14, 2018
First Posted
November 23, 2018
Study Start
November 15, 2018
Primary Completion
August 30, 2021
Study Completion
August 30, 2023
Last Updated
April 20, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share