Prodromal SchizophreniaNCT03751865
Early Detection and Intervention for Women At-risk of Psychosis
A study testing CBT and Psychoeducation in people with Prodromal Schizophrenia, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Prodromal Schizophrenia
- What is being tested?
- CBT and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Nov 2018to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
University of Hong Kong
Hong Kong, 0000
Yi Nam Suen
About this study
Official title: Early Detection and Intervention for Women At-risk of Psychosis in Hong Kong: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Prodromal Schizophrenia
- Being tested
- CBT, Psychoeducation
- Medical subject headings
- Schizotypal Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTBehavioural
A total of 8 CBT sessions will be provided to the participants, each session lasts for approximately 1.5 hour.
PsychoeducationBehavioural
A total of 8 psychoeducation sessions will be provided to the participants, each session lasts for approximately 1.5 hour.
| Study group | Role | What they receive |
|---|---|---|
| CBT group | Experimental | 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. Receives: Behavioral: CBT |
| Psychoeducation group | Active comparator | 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. Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 12-month post-intervention
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediate, 6- and 12-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start15 Nov 2018
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prodromal SchizophreniaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Eric Y.H. Chen, The University of Hong Kong
- Investigators
- Eric Yu Hai Chen, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751865
- Sponsor's protocol ID
- JCWowCBT
- Other IDs
- UW 18-231
- Status last verified
- Apr 2021
- First submitted
- 14 Jun 2018
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection and Intervention for Women At-risk of Psychosis in Hong Kong: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03751865
- Acronym / sponsor ID
- JCWowCBT
- Conditions
- Prodromal Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT group | Experimental | Behavioral: CBTThis 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. |
| Psychoeducation group | Active comparator | Behavioral: PsychoeducationThe 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBTA total of 8 CBT sessions will be provided to the participants, each session lasts for approximately 1.5 hour. | Behavioural | CBT group |
| PsychoeducationA total of 8 psychoeducation sessions will be provided to the participants, each session lasts for approximately 1.5 hour. | Behavioural | Psychoeducation group |
Primary outcome
Functioning: Measured by Social and Occupational Functioning Assessment Scale (SOFAS)
Time frame: Changes from baseline to immediate, 6- and 12-month post-intervention
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)
Time frame: Changes from baseline to immediate, 6- and 12-month post-intervention
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
Time frame: 12-month post-intervention
Proportion of subject that convert from at-risk state to psychosis
4 secondary outcomes
Positive psychotic symptoms
Time frame: Immediate, 6- and 12-month post-intervention
Beliefs about the auditory hallucination
Time frame: Immediate, 6- and 12-month post-intervention
Depressive symptoms
Time frame: Immediate, 6- and 12-month post-intervention
Social anxiety :Measured by Liebowitz Social Anxiety Scale (LSAS)
Time frame: Immediate, 6- and 12-month post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Yu Hai Chen, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT and Psychoeducation in people with Prodromal Schizophrenia, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Nam Suen, PhD (3917 9579, suenyn@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functioning: Measured by Social and Occupational Functioning Assessment Scale (SOFAS) (time frame: Changes from baseline to immediate, 6- and 12-month post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.