Randomization
The three informational meetings were organized and timed so that approximately 40 patients would sign up for the mindfulness course. The invitation letter informed the invitees that they would be randomized to either a treatment group or to a wait list group. At the end of the informational meeting, the patients were asked to decide whether they wished to participate on the given premises. The randomization procedure was a “simple randomization” that has been reported as working well in large groups [7]; this procedure was performed openly. The patients themselves drew small red or white pieces of paper that were concealed in envelopes. The colors indicated either the wait list or the treatment condition. The process of randomization and the assignment of patients to groups were performed by the study organizers (authors).
Control (Wait List) Condition
Patients assigned to the wait list received treatment at the pain center as usual. This included going to scheduled meetings with physicians, nurses, psychologists, or social workers. The wait list period lasted between 2 and 2.5 months. After this period, the patients were assigned to the MBSR program, and program and measurements were performed exactly as in the treatment group.
Intervention
Frequency and Setting
Participants were seen at weekly group meetings: Eight meetings were 3-hour sessions, and one meeting was 4.5 hours. A follow-up session was conducted 2 months after the last session. The study was based at the multidisciplinary pain center in Rigshospitalet, Copenhagen, which is a Danish state hospital. The sessions were held in a building owned by the hospital and located near the pain center.Theroomwasbigenoughtoalloweverybodytosit or lie down and was fully accessible to wheelchairs.
The three treatment groups included 22, 16, and 17 participants at the beginning of treatment. The sessions were conductedmainlybyafullytrainedandhighlyexperienced MBSR instructor with a strong background in meditation.
This teacher had completed a training and certification processwithJonKabat-ZinnandcolleaguesattheCenter for Mindfulness in Medicine, Health Care and Society at the University of Massachusetts in the United States. Some small parts of the sessions were conducted by a fellow MBSR teacher under close supervision by the main teacher to ensure treatment integrity. The second teacher was less experienced and uncertified but had been fully trained at the Mindfullife Institute in Denmark.
The mindfulness instructors had no relationship or contact with the patients other than at the mindfulness course. Program Techniques and Protocol
The mindfulness program was closely based on the standardMBSRprotocol[8].Participantsweretaughttomeditate daily for 45 minutes at home following instructions on a CD and were instructed to keep a diary.
During the pilot project, a few adjustments of the MBSR program were necessary to accommodate the patients, some of whom were quite disabled due to chronic pain. The following changes were made: The 2.5-hour MBSR sessions were extended to 3 hours in order to include a 20-minute break at which water and fruit was served and giving disabled participants the possibility to go to the restroom without missing much of the session. The additional10minutesofactual“teachingtime”alsoallowedfor repetition of didactical points.
The seventh so-called “all-day-session” was reduced to 4.5 hours from the standard 7.5 hours and included a 45-minute break with sandwiches, fruit, and water instead ofthestandard60-minutebreak.Reductionswereapplied inboththemindfulmovementstrainingandthetrainingsin walking meditation. Also, the “Hasty-Walking” intervention was omitted. Furthermore, this session was held on a regular program day rather than as an extra session in addition to the weekly sessions. The reason was logistic; the pain center was not staffed on the weekends.
Thephysicalexercisepartoftheinstruction(i.e.,yoga)had to be modified to accommodate the physical abilities of the specific study group. Patients had to participate in more than 60% of the meetings (i.e., attend at least six of the nine meetings) to be included in the study.