Coaching Intervention for Patients With Early Psychosis

NCT01792856 | Unknown

• 1 other identifier: UW 12-486
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia

Keywords

coaching; early psychosis; schizophrenia

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Subjective Wellbeing

  24 weeks

Study Arms (2)

intervention group

EXPERIMENTAL

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.

Other: Recovery-oriented intervention

control group

EXPERIMENTAL

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.

Other: psychoeducation

Interventions

Recovery-oriented intervention OTHER

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.

Also known as: Life-coaching approach

intervention group

psychoeducation OTHER

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.

Also known as: Control group

control group

Eligibility Criteria

• Age: 25 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnostic and Statistical Manual (DSM)-IV diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder or brief psychotic disorder;
• to 64 years;
• illness duration \<5 years;
• positive symptoms of mild or lower severity (rating \<4 in all items of Positive Symptom Subscale of PANSS);
• impaired functioning with SOFAS score \<=60;
• Cantonese speaking.

You may not qualify if:

• substance abuse
• organic psychotic disorders and
• mental retardation

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

Related Publications (14)

• van Os J, Kapur S. Schizophrenia. Lancet. 2009 Aug 22;374(9690):635-45. doi: 10.1016/S0140-6736(09)60995-8.

  PMID: 19700006 BACKGROUND

• World Health Organization. World Health Report 2001: mental health: new understanding, new hope. Geneva: WHO; 2001.

  BACKGROUND

• McGlashan TH. Early detection and intervention of schizophrenia: rationale and research. Br J Psychiatry Suppl. 1998;172(33):3-6.

  PMID: 9764119 BACKGROUND

• 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. doi: 10.1177/070674370705200709.

  PMID: 17688011 BACKGROUND

• 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. doi: 10.1176/appi.ajp.161.3.473.

  PMID: 14992973 BACKGROUND

• 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.

  PMID: 22311526 BACKGROUND

• 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.

  PMID: 18644851 BACKGROUND

• Bellack AS. Scientific and consumer models of recovery in schizophrenia: concordance, contrasts, and implications. Schizophr Bull. 2006 Jul;32(3):432-42. doi: 10.1093/schbul/sbj044. Epub 2006 Feb 3.

  PMID: 16461575 BACKGROUND

• 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.

  BACKGROUND

• Grant AM. The impact of life coaching on goal attainment, megacognition and mental health. Soc Behav Personal 2003; 31:253-264.

  BACKGROUND

• 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. doi: 10.1016/j.schres.2005.02.014.

  PMID: 16154054 BACKGROUND

• 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.

  PMID: 20462998 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 20603266 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Wing Chung Chang, Dr.

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wing Chung Chang, Dr.

CONTACT

852-22554304; wchung.chang@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 15, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

CN (1)