Back to resultsEarly Detection and Intervention for Women At-risk of Psychosis
Primary Purpose
Prodromal Schizophrenia
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
CBT
Psychoeducation
Sponsored by
About this trial
This is an interventional treatment trial for Prodromal Schizophrenia
Eligibility Criteria
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
Sites / Locations
- University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CBT group
Psychoeducation group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Conversion of psychosis
Proportion of subject that convert from at-risk state to psychosis
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT03751865
First Posted
June 14, 2018
Last Updated
April 18, 2021
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03751865
Brief Title
Early Detection and Intervention for Women At-risk of Psychosis
Official Title
Early Detection and Intervention for Women At-risk of Psychosis in Hong Kong: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prodromal Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CBT group
Arm Type
Experimental
Arm Description
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.
Arm Title
Psychoeducation group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
A total of 8 CBT sessions will be provided to the participants, each session lasts for approximately 1.5 hour.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
A total of 8 psychoeducation sessions will be provided to the participants, each session lasts for approximately 1.5 hour.
Primary Outcome Measure Information:
Title
Functioning: Measured by Social and Occupational Functioning Assessment Scale (SOFAS)
Description
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.
Time Frame
Changes from baseline to immediate, 6- and 12-month post-intervention
Title
Functioning: Measured by Role Functioning Scale (RFS)
Description
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.
Time Frame
Changes from baseline to immediate, 6- and 12-month post-intervention
Title
Conversion of psychosis
Description
Proportion of subject that convert from at-risk state to psychosis
Time Frame
12-month post-intervention
Secondary Outcome Measure Information:
Title
Positive psychotic symptoms
Description
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.
Time Frame
Immediate, 6- and 12-month post-intervention
Title
Beliefs about the auditory hallucination
Description
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.
Time Frame
Immediate, 6- and 12-month post-intervention
Title
Depressive symptoms
Description
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.
Time Frame
Immediate, 6- and 12-month post-intervention
Title
Social anxiety :Measured by Liebowitz Social Anxiety Scale (LSAS)
Description
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.
Time Frame
Immediate, 6- and 12-month post-intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Nam Suen, PhD
Phone
3917 9579
Email
suenyn@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Pui Sze Jade Wong
Phone
2831 5344
Email
jadewps@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Yu Hai Chen, MD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hong Kong
City
Hong Kong
ZIP/Postal Code
0000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Nam Suen
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Detection and Intervention for Women At-risk of Psychosis
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