After ethical approval was obtained, Wellbeing Services across Norfolk and Suffolk were contacted and provided with a short presentation followed by a question and answer session. This took place at monthly business meetings and clinician supervision sessions. Within these meetings a plan was collaboratively developed with the clinical team for how best to identify potentially suitable participants and to manage their participation at each recruitment site.
A flow chart detailing the study procedure is presented in figure 3. Once clinical teams had expressed an interest in the study and a willingness to refer, a member of that team approached patients they felt might be eligible to participate and provided them with a brief, simple description of the study and what participating involved. If the patient was interested in learning more they were asked if they would provide verbal consent for the
61 researcher to contact them and this was evidenced in the patient's clinical notes (e.g., ‘verbal consent for researcher to contact granted by patient’).
The researcher, upon being notified by the referring clinician, then contacted the patient by telephone. The patient was provided with a full explanation of the study and an opportunity to ask questions. The patient was then asked if they were potentially interested in participating. If the patient was interested, the participant details sheet (see appendix O) was completed, an initial appointment was arranged, and the participant information sheet and consent form were sent out to them.
After consent was obtained, the patient and researcher met face to face and the patient completed the screening measures (GAD-Q-IV, PHQ-9 & BSI). If the patient's scores were not suitable on these measures they would have been told that they were not eligible, thanked for their time and their clinical team would have been notified. As it was, all patients that were screened had suitable scores. Consequently they were invited to participate and asked if they wished their GP to be sent a letter notifying them of their participation (see appendix P).
The participant was then block randomised to one of the three baseline lengths (7, 9 or 11 days) and completed all outcome measures (GAD-7, GAD-Q-IV, STAI, SST, PSWQ & VAS).
For the duration of their baseline phase, the participant was asked to complete the daily VAS and PSWQ at approximately the same time each day. They were offered daily reminders to assist them with this however they all declined.
At the end of the baseline phase, the researcher met up again with the participant and non-daily outcome measures were completed for a second time. Following this the participant accessed the CBM-I program on their personal computer and completed their first session with the researcher present for instructional guidance. Similar to Blackwell
62 and Holmes (2010), the participant was asked to take a ‘field perspective’ when
completing the training scenarios (i.e., to imagine that they are in the scenarios looking through their own eyes as opposed to looking at themselves from an ‘observer
perspective’) (see Holmes, Coughtrey, & Connor, 2008).
For the remaining six sessions of the CBM-I phase, the participant was asked to continue completing daily sessions of the CBM-I task and to do so at approximately the same time every day in addition to the daily measures. Again, daily reminders were offered but all were declined.
After the CBM-I phase, the researcher met with the participant and outcome measures were completed for a third time. After this meeting, the participant continued to complete the daily measures for a further seven days during the follow-up phase.
At the one week follow-up, the researcher met with the participant and all outcome measures were completed for a final time. Finally the participant was fully debriefed, given the opportunity to ask any questions and reimbursed any accrued travel costs up to £5.00. Referring clinical teams were then notified of the participant’s study completion.
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Figure 3. Flow chart of the study procedure.
Clinician identifies a potentially suitable participant
Clinician contacts patient and briefly describes study.
If patient is interested in participating, they are asked to provide verbal consent for researcher
to contact them.
Researcher contacts patient by telephone, explains the study, answers any questions the
patient has, and asks if patient is potentially interested in participating.
If patient is interested, participant details sheet is completed.
The patient information sheet and consent form is sent to the patient.
If patient satisfies eligibility criteria:
Participant block randomised to baseline condition.
Participant completes all outcome measures.
Participant completes daily outcome measures for 7, 9 or 11 days duration depending on randomisation.
Researcher meets with participant:
Researcher guides participant through first CBM-I session.
All outcome measures are completed.
For 7 days (this includes first session with researcher present), participant completes:
Daily CBM-I session.
Daily measures.
Researcher meets with participant:
All outcome measures are completed.
For 7 days participant completes daily measures
Researcher meets with participant:
All outcome measures are completed.
Debrief Recruitment Allocation Baseline CBM-I Follow-up
Researcher and patient meet up.
If consent is obtained, screening questionnaires are administered and eligibility
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Results 3.1 Overview
This chapter presents the results of the present study. Data collected on the primary outcome measure, the PSWQ, as well as the VAS, are subjected to visual inspection to evaluate whether the CBM-I package produces a response. This is supplemented by the calculation of reliable change, clinically significant change and statistically significant change on outcomes at pre-assessment, pre-CBM-I, post CBM-I and one week follow-up.