Early Detection and Intervention for Women At-risk of Psychosis

Prodromal Schizophrenia Clinical Trial

Official title:

Early Detection and Intervention for Women At-risk of Psychosis in Hong Kong: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03751865
• Other study ID #: JCWowCBT
• Secondary ID: UW 18-231
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: August 30, 2023

Study information

• Verified date: April 2021
• Source: The University of Hong Kong
• Contact: Yi Nam Suen, PhD
• Phone: 3917 9579
• Email: suenyn[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Prodromal Schizophrenia
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Conversion of psychosis	Proportion of subject that convert from at-risk state to psychosis	12-month post-intervention
Secondary	Positive psychotic symptoms	Measurement of positive symptoms using the Chinese version of the Psychotic Symptom Rating Scales (C-PSYRATS). It comprises of the auditory hallucinations (AHS) and delusions subscales (DS). The AHS has 11 questions and the DS consists of 6 questions, each question has the responses ranging from 0-4. The higher score represents more severe positive psychotic symptoms.	Immediate, 6- and 12-month post-intervention
Secondary	Beliefs about the auditory hallucination	Measured by the Beliefs About Voices Questionnaire (BAVQ-R). The BAVQ-R has 35 questions, the 4 responses range from disagree, unsure, slightly agree to strongly agree. The higher score represents more convicted belief about the voices.	Immediate, 6- and 12-month post-intervention
Secondary	Depressive symptoms	Measured by the Calgary Depression Scale for Schizophrenia (CDSS). The scale consists of 9 questions, each has the response ranging from 0 to 3. The higher score presents more severe depressive symptoms.	Immediate, 6- and 12-month post-intervention
Secondary	Social anxiety :Measured by Liebowitz Social Anxiety Scale (LSAS)	Measured by Liebowitz Social Anxiety Scale (LSAS). The LSAS consists of 24 questions, the rater has to rate from 0-3 in Fear or Anxiety domain or Avoidance domain for each of the 24 questions. The higher score represents more severe social anxiety.	Immediate, 6- and 12-month post-intervention