The current study protocol was approved by the Joint Chinese University of Hong Kong and New Territories East Cluster (CUHK-NTEC) Clinical Research Ethics Committee (CREC).
This study is a randomized controlled trial with three study arms: the MBCT programme led by trained MBCT instructors, Psycho-Education Group (PEG) using CBT principles led by clinical psychologist, and usual care (UC) which will be offered MBCT at the end of the study for ethical reasons. The MBCT and group PEG consist of eight 2-hour weekly sessions. Outcome measures of all participants will be collected at similar time points (baseline, immediately post intervention, and at 3, 6 and 9 months post intervention). The previous studies that evaluated the effectiveness of MBCT for anxiety did not employed a control group; the inclusion of comparison groups, a usual care group and PEG, will be important in evaluating the benefits of MBCT.
Three instructors with at least two-year experience in teaching MBSR or MBCT will lead the MBCT groups while three clinical psychologists with at least master degree in clinical psychology will be hired for conducting the PEG.
Entry criteria for the current proposed study will include all of the followings:
1) being 21-65 years of age; 2) having, at baseline assessment, a DSM-IV TR principal diagnosis of generalized anxiety disorder on SCID (Structured Clinical Interview for DSM-IV) [13
] and a score of 19 or above using the Chinese version of the Beck Anxiety Inventory [14
]; 3) can understand Cantonese; 4) are willing to attend either the mindfulness based cognitive therapy program or the group cognitive behavioural therapy; 5) if patient is on medication for his/her condition, he or she should be on stable doses of medication for 3 months before starting treatment.
Exclusion criteria will include any one of the followings: 1) illiterate subjects as they will not be able to complete the homework diary; 2) psychiatric and medical comorbidities that are potentially life threatening (i.e. psychosis, suicidal ideation, terminal medical illness) or those expected to severely limit patient participation or adherence (e.g. psychosis, current substance abuse, dementia, pregnancy); 3) those who are currently seeing a cognitive behavioural therapist or psychotherapists/counsellors.
Patients will be recruited from: 1) referral from doctors who work in the General Outpatient Clinics (GOPC) of the New Territories East Cluster of the Hospital Authority and who are interested in this study; 2) review of those who have been referred to be seen by a psychiatrist for anxiety symptoms and who are on the wait list to be seen for at least 12 months (currently there are more than 500 patients in this category with a majority stating that their major complaint is anxiety);. 3) a website set up by the University that provide health-related information which is available to general public.
All interested subjects will be screened on phone by a trained research assistant to determine eligibility in accordance to the pre-set inclusion and exclusion criteria. Those eligible subjects will then be scheduled to have a diagnostic interview with a family physician; the family physician will further confirm the eligibly with the Structured Clinical Interview for DSM-IV SCID [13
]. Both the family physician and the research assistant are trained to use the DSM-IV SCID with a psychiatrist. All eligible participants will be seen by the principal investigator (PI) 1-4 weeks before the start of the interventions to further explain the study, to confirm eligibility, and provide informed consent.
A statistician who is not involved in any part of the study independently randomized participants by using a predetermined random table generated by Microsoft Excel 2002. These numbers will not be decoded until the intervention group is assigned.
The allocation is concealed from the researchers, who carries out the baseline assessment or recorded the data, and the statistician who carried out the analysis. The allocation is unknown to the participants until the first appointment.
The research study has been approved by the Joint Chinese University of Hong Kong-New Territory East Cluster (CUHK-NTEC) Ethics Committee.
Mindfulness Based Cognitive Therapy (MBCT) plus usual care - treatment arm
After an initial individual orientation session, the MBCT program will be delivered by an instructor who has been trained in mindfulness based cognitive therapy and who has more than 2 years of training experience in MBCT. One programme of 18 participants will be conducted for 8 weeks with 2 hours group training sessions. The programme will include daily homework exercises which will include guided (taped) or unguided awareness exercises directed at increasing moment by moment nonjudgmental awareness of bodily sensations, thoughts, and feelings together with exercises designed to integrate application of awareness skills into daily life. Key themes of MBCT include empowerment of participants and a focus on awareness and acceptance of experience in the moment. Participants are helped to develop a "decentred" perspective on thoughts and feelings, in which these are viewed as passing events in the mind.
Psycho-Education Programme based on cognitive behavioural therapy principle - active control arm
The Psycho-Education Programme is designed to be comparable to MBCT in level of structure, therapist's contact and attention, with participants required to adhere to an agenda during sessions with homework assignments of similar duration. It will consist of a series of 8 weekly 2-hour sessions. The sessions are based on White's book on Treating Anxiety and Stress [15
]. All instructors will be qualified clinical psychologists with training in cognitive behavioral therapy.
Usual care control (UC)
Usual care refers to primary or community care used by participants. In Hong Kong, the majority of primary care is provided by the private sector with around 20% provided by public outpatient clinics. In general, patients who use public outpatient clinics tend to be older, with chronic conditions and who are from a lower socio-economic status.
As the consultation time is usually short (usually one doctor sees about 40-45 patients in one morning), they may be lack of time to deal with patients who present with emotional problems. As a result, usual care can mean minimal care especially if the patients are from lower socio-economic status. The use of this control is to test the effectiveness of MBCT against minimal intervention. All controls will be offered MBCT after the end of the study for ethical reasons.
Measures at baseline and each follow-up: Subjects' demographic data including age, sex, marital status, education status, personal monthly income, religious belief, and all other outcome measures (described below), use of medication (including psychotropics), and experience with mindfulness and yoga, together with medical history including psychiatric history will be collected by a trained interviewer. After the baseline visit, subjects will be randomized as described above. The fidelity of the intervention will be ensured and monitored by a random review of audiotapes that are recorded during all sessions.