Psychosis Clinical Trial
— MBIpOfficial title:
Brief Mindfulness-Based Intervention for Early Psychosis: A Randomized Controlled Study
Depressive mood and anxiety are prevalent in patients suffering from early psychosis.
Treatments focused on these dimensions are rarely seen. Meanwhile, growing evidence showed
Mindfulness-based intervention (MBI) as an effective option in handling depression and
anxiety. There is a great possibility that MBI is also useful in depression and anxiety
associating with early psychosis. Given that cost-effectiveness is widely concerned in Hong
Kong or any other countries, a brief intervention is more favored. Current paper is a study
protocol for a randomized controlled trial which assess the feasibility of a 7-week
mindfulness-based intervention in patients with early psychosis targeting on their
depressive mood and anxiety.
In this RCT, 60 patients aged 18-65 with early psychosis less than 5 years' duration and
mild depressive mood or anxiety will be invited to join this single blind randomized
controlled trial. After baseline assessments, eligible participants will be, using third
party simple randomization, randomly assigned to either the 7-week Mindfulness-based
Intervention (MBI), or the psychoeducation group as control.
The primary outcome is depressive mood and anxiety levels at post-intervention and 3 months.
The secondary outcomes include life functioning, quality of life, other general clinical
symptoms and mindfulness ability. Qualitative interviews will help evaluate and measure the
feasibility of the intervention. Data will be analyzed according to the intention-to-treat
principle.
This randomized trial offers an insight into mindfulness-based intervention and its
effectiveness on psychosis concomitants. It provides the foundation for future evaluation
and implementation of an effective and cost-efficient treatment option.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Cantonese-speaking patients aged 18-65, who are service users of the aforementioned community mental health services in Hong Kong. - diagnosis of Schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, psychotic disorder not otherwise specified, or manic episodes with psychotic features according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) and less than 5 years' duration since onset of psychosis. - present with mild depressive or anxiety symptoms (PANSS items G2 or G6 scores higher than or equal to 3; any item on CDSS scores more than or equal to 1). - They must have an ability to consent, stable positive symptoms (PANSS symptomatic items: P1-P7 scores less than or equal to 3) and good medication compliance (assessed by clinical interview, informant interview, and pill-counting). Exclusion Criteria: - Known organic brain disorder - Known history of intellectual disability, - Diagnosed with drug-induced psychosis, - Practice of mindfulness (in forms of yoga, Tai Chi, etc.) more than twice a week during the previous three months, - Previous or current substance abuse, - High risk features associated with acute psychotic episodes, and - Questionable adherence to medication treatment and follow-up. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | The University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Program evaluation | In order to evaluate the MBI for further development and to assist interpretation of results, qualitative semi-structured interviews will be conducted after the seven weeks of MBI. The interview primarily looks at the perceived processes of change, helpful aspects of the process, and therapeutic value of the MBI. Each interview will be recorded and transcribed | 19weeks | No |
Primary | Depressive mood | Depressive mood is measured by the Positive and Negative Symptom Scale Item G2 (PANSS-G2); Calgary Depression Scale for Schizophrenics (CDSS); Depression Anxiety Stress Scale - Depression subscale (DASS-21-D) and Beck Depression Inventory - II (BDI-II). | 19weeks | No |
Primary | Anxiety | Anxiety is measured by DASS-21 - Anxiety subscale and PANSS item G6. | 19weeks | No |
Secondary | Quality of Life | measured by Short Form 12 (SF12) | 19weeks | No |
Secondary | Life Functioning | rated on the Social and Occupational Functioning Assessment Scale (SOFAS) | 19weeks | No |
Secondary | Mindfulness | two separate mindfulness scales: the Five Facet Mindfulness Questionnaire (FFMQ) and the Southampton Mindfulness Questionnaire (SMQ).We also take note of the number of practices conducted individually by participants during each week of the intervention period and also the frequency of practice after the seven weeks of MBI. | 19weeks | No |
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