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Early Detection and Intervention for Women At-risk of Psychosis

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03751865
Enrollment
160
Registered
2018-11-23
Start date
2018-11-15
Completion date
2023-08-30
Last updated
2021-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prodromal Schizophrenia

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.

Interventions

BEHAVIORALCBT

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

BEHAVIORALPsychoeducation

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

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Functioning: Measured by Social and Occupational Functioning Assessment Scale (SOFAS)Changes from baseline to immediate, 6- and 12-month post-interventionMeasured 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)Changes from baseline to immediate, 6- and 12-month post-interventionMeasured 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 psychosis12-month post-interventionProportion of subject that convert from at-risk state to psychosis

Secondary

MeasureTime frameDescription
Positive psychotic symptomsImmediate, 6- and 12-month post-interventionMeasurement 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 hallucinationImmediate, 6- and 12-month post-interventionMeasured 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 symptomsImmediate, 6- and 12-month post-interventionMeasured 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)Immediate, 6- and 12-month post-interventionMeasured 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.

Countries

Hong Kong

Contacts

Primary ContactYi Nam Suen, PhD
suenyn@hku.hk3917 9579
Backup ContactPui Sze Jade Wong
jadewps@hku.hk2831 5344

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026