Early Detection and Intervention for Women At-risk of Psychosis

NCT ID: NCT03751865

Last Updated: 2021-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2023-08-30

Brief Summary

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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.

Detailed Description

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Eligible subjects with informed consent provided will be randomly assigned to the cognitive behavioural therapy (CBT) group or psychoeducation group. Each group consists of 8 session spanning for 8 week.

Conditions

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Prodromal Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CBT group

This 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.

Group Type EXPERIMENTAL

CBT

Intervention Type BEHAVIORAL

A total of 8 CBT sessions will be provided to the participants, each session lasts for approximately 1.5 hour.

Psychoeducation group

The 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.

Group Type ACTIVE_COMPARATOR

Psychoeducation

Intervention Type BEHAVIORAL

A total of 8 psychoeducation sessions will be provided to the participants, each session lasts for approximately 1.5 hour.

Interventions

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CBT

A total of 8 CBT sessions will be provided to the participants, each session lasts for approximately 1.5 hour.

Intervention Type BEHAVIORAL

Psychoeducation

A total of 8 psychoeducation sessions will be provided to the participants, each session lasts for approximately 1.5 hour.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Professor Eric Y.H. Chen

Chi-li Pao Foundation Professor of Psychiatry; Chair Professor in Psychiatry; Head, Department of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Yu Hai Chen, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Yi Nam Suen, PhD

Role: CONTACT

3917 9579

Pui Sze Jade Wong

Role: CONTACT

2831 5344

Facility Contacts

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Yi Nam Suen

Role: primary

Other Identifiers

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UW 18-231

Identifier Type: OTHER

Identifier Source: secondary_id

JCWowCBT

Identifier Type: -

Identifier Source: org_study_id

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