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.
Status | Not yet recruiting |
Enrollment | 140 |
Est. completion date | August 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 25 Years to 64 Years |
Eligibility |
Inclusion Criteria: 1. Diagnostic and Statistical Manual (DSM)-IV diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder or brief psychotic disorder; 2. 26 to 64 years; 3. illness duration <5 years; 4. positive symptoms of mild or lower severity (rating <4 in all items of Positive Symptom Subscale of PANSS); 5. impaired functioning with SOFAS score <=60; 6. Cantonese speaking. Exclusion Criteria: - substance abuse - organic psychotic disorders and - mental retardation |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | The University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
China,
Bellack AS. Scientific and consumer models of recovery in schizophrenia: concordance, contrasts, and implications. Schizophr Bull. 2006 Jul;32(3):432-42. Epub 2006 Feb 3. — View Citation
Bora R, Leaning S, Moores A, Roberts G. Life coaching for mental health recovery: the emerging practice of recovery coaching. Adv Psychiatr Treat 2010; 16:459-467.
Chang WC, Tang JY, Hui CL, Lam MM, Chan SK, Wong GH, Chiu CP, Chen EY. Prediction of remission and recovery in young people presenting with first-episode psychosis in Hong Kong: a 3-year follow-up study. Aust N Z J Psychiatry. 2012 Feb;46(2):100-8. doi: 10.1177/0004867411428015. — View Citation
Foussias G, Remington G. Negative symptoms in schizophrenia: avolition and Occam's razor. Schizophr Bull. 2010 Mar;36(2):359-69. doi: 10.1093/schbul/sbn094. Epub 2008 Jul 21. Review. — View Citation
Grant AM. The impact of life coaching on goal attainment, megacognition and mental health. Soc Behav Personal 2003; 31:253-264.
Green LS, Oades LG, Grant M. Cognitive-behavioral, solution-focused life coaching: enhancing goal striving, wellbeing, and hope. J Positive Psychology 2006; 1:142-149.
Harvey PO, Lepage M, Malla A. Benefits of enriched intervention compared with standard care for patients with recent-onset psychosis: a metaanalytic approach. Can J Psychiatry. 2007 Jul;52(7):464-72. — View Citation
Lam MM, Pearson V, Ng RM, Chiu CP, Law CW, Chen EY. What does recovery from psychosis mean? Perceptions of young first-episode patients. Int J Soc Psychiatry. 2011 Nov;57(6):580-7. doi: 10.1177/0020764010374418. Epub 2010 Jul 5. — View Citation
McGlashan TH. Early detection and intervention of schizophrenia: rationale and research. Br J Psychiatry Suppl. 1998;172(33):3-6. Review. — View Citation
Nakagami E, Hoe M, Brekke JS. The prospective relationships among intrinsic motivation, neurocognition, and psychosocial functioning in schizophrenia. Schizophr Bull. 2010 Sep;36(5):935-48. doi: 10.1093/schbul/sbq043. Epub 2010 May 12. — View Citation
Pratt SI, Mueser KT, Smith TE, Lu W. Self-efficacy and psychosocial functioning in schizophrenia: a mediational analysis. Schizophr Res. 2005 Oct 15;78(2-3):187-97. — View Citation
Robinson DG, Woerner MG, McMeniman M, Mendelowitz A, Bilder RM. Symptomatic and functional recovery from a first episode of schizophrenia or schizoaffective disorder. Am J Psychiatry. 2004 Mar;161(3):473-9. — View Citation
van Os J, Kapur S. Schizophrenia. Lancet. 2009 Aug 22;374(9690):635-45. doi: 10.1016/S0140-6736(09)60995-8. Review. — View Citation
World Health Organization. World Health Report 2001: mental health: new understanding, new hope. Geneva: WHO; 2001.
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Social functioning | Social Functioning will be measured by Social and Occupational Functioning Assessment Scale (SOFAS) and Role Functioning Scale and Occupational Life Functioning Scale and Social Functioning Scale (SFS). Vocational status will be obtained. To evaluate the efficacy of recovery-oriented coaching, a series of analysis of variance (ANOVAs) are used to test the significance of differences between intervention and control groups at 12 weeks and 24 weeks on social functioning. |
24 weeks | No |
Primary | Negative Symptoms (esp.intrinsic motivation) | Positive and Negative Syndrome Scale (PANSS) and Scale for the Assessment of Negative Symptoms (SANS) will be used to assess negative symptoms. Intrinsic motivation is evaluated using the sum of 3 items from Quality of Life Scale i.e., sense of purpose, motivation and curiosity. A series of analysis of variance (ANOVAs) are used to test the significance of differences between intervention and control groups at 12 weeks and 24 weeks on negative symptoms and Intrinsic motivation |
24weeks | No |
Secondary | Subjective Wellbeing | Quality of Life (SF-12), state hope scale , chinese general self-efficacy scale and Rosenberg self-esteem scale will be used to evaluate subjective wellbeing of patients. A series of analysis of variance (ANOCAs) are used to test the significance of differences between intervention and control groups at 12 weeks and 24 weeks. |
24 weeks | No |
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