Schizophrenia Clinical Trial
Official title:
Randomized Controlled Trial on Recovery-oriented Coaching Intervention for Patients With Early Psychosis
Jockey Club Early Psychosis (JCEP) project is a territory-wide specialized EI service that
is launched in August 2009 and provides 3-year phase-specific intervention for adult
patients presenting with first-episode psychosis (FEP) to psychiatric units of Hospital
Authority (HA). To promote early functional recovery, JCEP project develops
recovery-oriented intervention based on life coaching approach (recovery-oriented coaching)
in addition to case management. This is a structured group-based coaching program
incorporating cognitive-behavioural and solution-focused therapeutic components. The program
facilitates patients to undergo active change process via identification of achievable
goals, formulation of action plans, provision of feedback and progress monitoring for goal
attainment. Subjects will be randomized (block size: 2) to receive either recovery-oriented
coaching program (intervention group) or supportive therapy (control group).
Intervention group Subjects are scheduled to receive a 6-month group-based recovery-oriented
coaching program. This is a structured, manualised treatment program based on life coaching
principles with cognitive-behavioural and solution-focused elements incorporated. It guides
subjects to undergo an active, yet stepwise change process by stimulating motivation,
setting achievable goals, generation of action plans via collaborative exploration,
fostering self-regulatory capacity, and provision of autonomy-supportive treatment
environment and peer support. Subjects' perceived competence, sense of control,
self-management skills and hence functioning will be improved via successful experiences and
positive feelings generated after attainment of self-initiated goals. Cognitive-behavioural
techniques such as self-monitoring, activity scheduling and behavioural modification will be
employed.
Control group Subjects will receive group-based supportive therapy provided by case managers
of JCEP project. The therapy provides patients with psychoeducation about psychosis, stress
management, emotional and social support. Coaching and cognitive-behavioural techniques will
not be incorporated. Therapy sessions and duration will be comparable to that of
recovery-oriented coaching program.
Assessments Each subject will be assessed at three time points, i.e., baseline before
randomization (T1), 12 weeks (T2, post-phase I intervention) and 24 weeks (T3, post-phase II
intervention). Assessments on symptomatology, functioning and subjective wellbeing will be
administered at all time points. Cognitive and reinforcement learning assessments will be
conducted at T1 and T3. functional magnetic resonance imaging (fMRI) will be performed at T1
and T3 for the first 20 subjects recruited in each treatment group. A group of healthy
volunteers matched in sex, age and educational level will be recruited from the community
with fMRI, cognitive and reinforcement learning evaluations done at T1 and T3. To maintain
blinding to treatment assignment, assessments will be conducted by research assistants who
are independent of treatment delivery and randomization. Subjects will be trained to not
reveal their treatment allocation before each follow-up assessment.
Background, current evidence and key references
Psychotic disorders including schizophrenia are severe mental illnesses that affect 3% of
the population and constitute an enormous burden to patients and the society. They cause
profound disruptions in patients' functioning including independent living skills,
relationships, scholastic and vocational development, and are ranked by World Health
Organization as the third most disabling medical condition. In an attempt to minimize
long-term disability, numerous early intervention (EI) programs for psychosis have been
established worldwide in the past decade. It is based on the premise that shortening of
treatment delay and provision of phase-specific treatments in the initial few years of
psychosis can improve illness outcome. Literature indicated that patients who received EI
had better clinical and functional outcomes than those treated by standard psychiatric care.
Nonetheless, accumulating evidence has suggested that a significant proportion of early
psychosis patients exhibited functional deterioration even in the presence of clinical
remission. Studies have also consistently shown that patients with psychosis frequently
experience motivational deficits and diminished goal-directed behaviours which are key
negative symptoms predictive of functional outcome. Functional disability thus represents an
unmet therapeutic need in EI for psychosis.
In this regard, there is a shift of therapeutic focus from symptom control to functional
enhancement. It is also increasingly recognized that patients' perspectives should be taken
into consideration in conceptualizing functional recovery and developing recovery-oriented
service to further improve functional outcome . Owing to lack of effective treatments in
addressing functional impairment, recently, there is an emerging interest in adopting life
coaching to complement other interventions by its specific focus on motivation and
functioning. Life coaching is defined as a collaborative, solution-focused, outcome-oriented
and systematic process which aims to facilitate enhancement of life experience and goal
attainment of an individual in various life domains . It is based on the theoretical
framework of positive psychology and behavioural change model, and targets at building up an
individual's potential via fostering hope, motivation, self-efficacy and self-regulation.
The principles of life coaching thus closely align with recovery orientation that emphasizes
on self-initiation and empowerment via person-centred and strength-based approach. In fact,
empirical evidence suggested that hopelessness and low self-efficacy were associated with
poor functioning in early psychosis. Conversely, increased motivation was shown to enhance
both functional and cognitive outcomes in schizophrenia . Additionally, studies evaluating
coaching in non-clinical population found that it significantly improved subjects'
motivation and psychological wellbeing. Despite the growing recognition and adoption of life
coaching approach in mental health services, it has rarely been applied in the early course
of psychotic disorder.
Jockey Club Early Psychosis (JCEP) project is a territory-wide specialized EI service that
is launched in August 2009 and provides 3-year phase-specific intervention for adult
patients presenting with first-episode psychosis (FEP) to psychiatric units of Hospital
Authority (HA). To promote early functional recovery, JCEP project develops
recovery-oriented intervention based on life coaching approach (recovery-oriented coaching)
in addition to case management. This is a structured, group-based coaching program
incorporating cognitive-behavioural and solution-focused therapeutic components. The program
facilitates patients to undergo active change process via identification of achievable
goals, formulation of action plans, provision of feedback and progress monitoring for goal
attainment. Unlike the majority of therapies that focus mainly on symptoms and functional
deficiencies, this program is strength-oriented and aims to facilitate patients to gain a
sense of agency and to achieve sustained functional improvement via firstly, enhancing
motivation, self-regulation and competence by positive reinforcement obtained from
successive accomplishments of self-determined goals; secondly, providing an
autonomy-supportive treatment environment with a context of recovery expectations; and
thirdly, facilitating formation of supportive social network in group-based setting.
We have previously examined perceptions of early psychosis patients on recovery, with
achievement of adequate functioning being regarded as a key element signifying recovery. Our
earlier study on FEP patients with EI revealed that less than one-fifth achieved recovery
and only 43% of remitted patients were in functional remission at the end of 3-year
follow-up. Thus, in line with the literature, our findings indicated an urgent need for
developing effective interventions to optimize patients' functional outcome in the early
illness stage which is otherwise regarded as a critical window of opportunity for minimizing
long-term disability. In this context, recovery-oriented coaching program which specifically
addresses motivational and functional impairments may prove to be an effective psychosocial
intervention for promoting functional recovery, and thereby worthy of systematic evaluation
in patients with early psychosis.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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