None listed
Conditions
Brief summary
Negative symptoms are frequently experienced by people with schizophrenia. People with negative symptoms often have impaired social functioning and reduced quality of life. There is some evidence that Cognitive Behavioural Therapy (CBT) results in a modest reduction in negative symptoms. It is unclear if similar effects can be achieved using Behavioural Activation (BA). This study will examine the feasibility and acceptability of implementing a BA tele-trial delivered collaboratively with three rural mental health services (Flinders and Upper North Local Health Network, Riverland and Coorong Local Health Network, and Limestone Coast Local Health network) that provide mental health services for people with Serious Mental Illness. Methods We aim to recruit 60 consumers aged 18 years or above with negative symptoms of schizophrenia as indicated by mild to moderate negative symptoms [greater than 3 on at least two negative symptom items from the Positive and Negative Syndrome Scale (PANSS). In addition, we aim to recruit eight mental health workers from three rural mental health services in South Australia and prepare them to deliver BA to consumers of their service. Consumers will be randomised to receive BA plus usual mental health care service or usual mental health care service alone. The BA plus usual mental health care service component will involve 12 sessions of up to one hour in duration which will be delivered over 12 weeks. Our team of experts will support the mental health workers to deliver BA via telehealth supervision and structure. This also helps to ensure fidelity to the intervention. Specific BA techniques that will be applied include the identification of depressed behaviours; analysis of the triggers and consequences of depressed behaviours; monitoring of activities; development of alternative goal-orientated behaviours; scheduling of activities; and the development of alternative behavioural responses to rumination. Changes in negative symptoms of schizophrenia (primary outcome) and depression (secondary outcome) will be assessed at three-time points: (a) at baseline, at 6 weeks, and 3-month follow-ups. Changes in health-related quality of life (secondary outcome) will be assessed at two-time points: (a) at baseline and (b) immediately at postintervention after six weeks. We will use the PHQ 9 and the SF36 scales to assess changes in mood and health-related quality of life, respectively. Descriptive statistics and thematic analysis will be used to assess feasibility and acceptability.
Interventions
The intervention is Behavioural Activation (BA). Our protocol was informed by a systematic review of BA as an adjunct treatment for people with negative symptoms of schizophrenia. The study will be conducted at the three rural mental health centres which provide inpatient care for people with schizophrenia. In the intervention group, patients will receive BA in addition to their usual care. This will involve up to 12 sessions of BA over 12 weeks. This will be administered on a 1-1 by the mental
The intervention is Behavioural Activation (BA). Our protocol was informed by a systematic review of BA as an adjunct treatment for people with negative symptoms of schizophrenia. The study will be conducted at the three rural mental health centres which provide inpatient care for people with schizophrenia. In the intervention group, patients will receive BA in addition to their usual care. This will involve up to 12 sessions of BA over 12 weeks. This will be administered on a 1-1 by the mental health worker and an expert in BA via a digital tele trial model. Each 1-1 session will last up to one hour. Each session will focus upon reviewing the previous weeks activity schedule. Worker adherence to the treatment protocol will be monitored via tele health live supervision of the conversation between the worker and the consumer from experts in BA. The workers at the thee centres will be trained to practice BA competently by completing the credited and established online "Professional Certificate in Behavioural Activation" offered by the University of South Australia. Workers will complete the training program as part of the intervention. The course consists of five modules and takes approximately 157 hours to complete. Consumers with negative symptoms will be asked to participate after the workers have completed the Professional Certificate in Behavioural Activation. Behavioural Activation works by teaching people with the skills to schedule activity which facilitate routine, reward and new activity which promotes wellbeing. Based on our systematic review, a dose of twelve sessions of Behavioural Activation is appropriate.
Sponsors
SA/NT Regional Clinical Trial Coordinating Centre (SA/NT RCCC)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
(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.
Outcome results
None listed