Co-delivery of tele trial Behavioural Activation in people with negative symptoms of schizophrenia: a feasibility Randomised Controlled Trial
- Conditions
- SchizophreniaMental Health - Schizophrenia
- Registration Number
- ACTRN12623000348651
- Lead Sponsor
- SA/NT Regional Clinical Trial Coordinating Centre (SA/NT RCCC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 60
The study will comprise two groups of participants: Mental health workers and consumers with a diagnosis of schizophrenia with negative symptoms.
(a)Mental health workers
Mental health workers employed by the Flinders and Upper North, Limestone Coast, and Riverland and Coorong Local Health Networks of South Australia who complete the online training in BA and agree to participate in the study. The mental health workers may include but are not limited to, mental health nurses, social workers, support workers, and occupational therapists.
(b)Consumers with mild-to-moderate negative symptoms as determined using the Positive and Negative Symptom scale.
(i)Are aged 18 years or above.
(ii)Are receiving a mental health service from the three participating mental health sites established for the Flinders and Upper North, Limestone Coast, and the Riverland, and Coorong Local Health Networks.
(iii)Are experiencing mild to moderate negative symptoms [greater than 3 on at least two negative symptom items from the Positive and Negative Syndrome Scale (PANSS).
(iv)Understand, read, write, and speak English.
(v)Provide informed consent.
(a)Mental health workers
Mental health workers that have not completed BA training even though they may be providing mental health care service at any of the three Local Health Networks in rural South Australia.
(b)Consumers
(i)Have depressive symptoms and achieve a baseline score of 15+ on the PHQ-9 scale or acute depression and need to be seen by a psychiatrist. These people will be excluded from the study for their safety.
(ii)Express suicidal ideation or are at risk of self-harm, suicide, homicide, or present a risk to others. These potential participants will be referred to a general practitioner or mental health professional for support.
(iii)Have multiple mental health diagnoses.
(iv)Have a disorder that impedes effective communication (eg, severe sensory impairment) or experience difficulty understanding or communicating effectively in English, and interpretation services are not available.
(v)Are assessed by mental health workers as being incapable of giving informed consent to participate in the study due to their medical circumstances.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome will be a change in negative symptoms as assessed by the research tele-trial nurse using the Positive and Negative Syndrome Scale (PANSS). [ The primary outcome measures will be completed at three time points (a) at baseline (0 weeks), (b) at 12 weeks post-intervention, (primary endpoint).]
- Secondary Outcome Measures
Name Time Method evel of health-related quality of life as measured by the 36-Item Short Form Health Survey questionnaire (SF 36). The SF 36 measures eight health-related domains including physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotion, and mental health. [ In this study, we will administer the SF 36 survey at two time points: (a) at baseline (0 weeks) and (b) at 12 weeks post intervention.];The PHQ 9 is a 4-point Likert-type scale (0, absent; 1, mild; 2, moderate; 3, severe) with nine items that correspond to the DSM-IV Diagnostic Criterion A symptoms for major depressive disorder. [ The secondary outcome (depression) measures will be completed at three time points (a) at baseline (0 weeks) and (b) at 12 weeks post intervention.];We will record the number of consumers who complete BA treatment by completing an audit of the clinical notes.[ We will collect this data at 12 weeks post intervention.]