Early Detection and Intervention for Women At-risk of Psychosis

Study Overview
=================
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.

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

Conditions
-----------------
Prodromal Schizophrenia

Intervention / Treatment
-----------------
* Behavioral: CBT
* Behavioral: Psychoeducation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT group<br>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. | Behavioral: CBT<br>* A total of 8 CBT sessions will be provided to the participants, each session lasts for approximately 1.5 hour.<br>|
| Active Comparator: Psychoeducation group<br>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. | Behavioral: Psychoeducation<br>* A total of 8 psychoeducation sessions will be provided to the participants, each session lasts for approximately 1.5 hour.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |