Ethical Issues and Ethical Approval

The following ethical issues were considered prior to obtaining ethical approval for the study. Ethical approval was granted from the University of Lincoln

SOPREC (see Appendix H for email confirmation of ethical approval). The study obtained favourable opinion with no amendments. The study was conducted in accordance with the ethical principles stipulated by the BPS (2006).

2.5.1 Informed consent. Following screening for eligibility, participants were provided with an information sheet (Appendix I) and given 24 hours to reflect on the study - at which point they were invited to meet with the researcher who went through a paper version of the information sheet and

187 provided details of the study. Participants were invited to ask questions and seek clarification on anything they were unclear on. Participants were informed that participation was voluntary and they were free to withdraw at any time.

Participants were also given the option to remove data up to two weeks following collection at any stage during the study, after which point they were informed that the information provided would remain in the study. Participants were also informed that although they were not obliged to answer all questions during enrolment to the study that if they declined to answer too many of them, they would be released from the study as this would compromise the data. Prior to starting the study it was highlighted to all participants that the evidence for ACT for this clinical problem is in its infancy and may not have any beneficial effects. It was noted that although the current literature has not highlighted any iatrogenic effects, the potential risk cannot be eliminated and so all participants were made aware of this possibility. Participants were then asked if they wished to take part in the study and asked to sign a consent form; one copy of which was kept by the participant and one copy was retained in the study files (Appendix J).

2.5.2. Protection of research participants. On starting the study, participants were provided with the contact details for the student counselling services within the University of Lincoln and information about the eating disorder charity, BEAT (Beating eating disorders). All participants were also informed that they could talk to the researcher if they had any concerns regarding their eating or emotional wellbeing, and were also encouraged to speak to their GP if necessary. In the information sheet, participants were informed that their information would remain confidential but if the researcher had any concerns regarding their emotional wellbeing or any perceived risks relating to their safety or that of others, this would be discussed with her research supervisors and also passed onto the appropriate authorities, if relevant.

Adverse events as a result of participating in this research were not expected. However, possible risks which the researcher was aware of included;

participants finding the experience of being weighed embarrassing or mildly distressing or participants finding answering questions about their eating habits upsetting or experiencing emotional discomfort as it was possible that the

188 intervention may increase their awareness of their eating habits. However, any distress experienced was considered likely to be minimal. Nevertheless, to help minimise such potential risks, a number of safety measures were put in place:

(a) from the outset participants were informed explicitly in the information sheet of the possibility of experiencing mild distress associated with a possible

increase in awareness of eating behaviour; (b) any weigh-ins or questionnaires were conducted in private or in the presence of the researcher only; (c)

participants were only asked to remove their shoes and jacket for the BMI assessment so as to uphold their dignity; (d) participants were given the option of viewing their weight on the scales and asked if they wished to know whether there was an increase/decrease from the previous weigh-in assessment; (e) participants were informed that they could withdraw at any time; and (f)

participants were informed that the researcher (a Trainee Clinical Psychologist) was available to offer support; and if required participants would be directed to suitable services should they need additional advice (e.g., counselling services, GP).

As mentioned previously, participants were compensated for the time they invested in the study. Given the intensive nature of the study, it was

considered ethically appropriate to reimburse participants for their time. Each of the six participants was provided with £50 in cash after they have completed the post-intervention measures and a further £10 in cash if they completed the assessments at the three month follow-up stage. Participants were informed that should they withdraw from the study part-way through they would not be reimbursed. The rationale for this was as it was hoped that reimbursing participants for their time upon study completion (one instalment of £50 post-intervention and the final instalment of £10 at follow-up) would serve as an incentive to participants to fully complete the intervention and reduce the likelihood of attrition part way through. Given that treatment non-completion may be considered to have adverse effects (McMurran, Huband & Overton, 2010), this step was considered ethically appropriate. To acknowledge the involvement of participants in the study, the researcher sent them occasional emails thanking them for their participation and acknowledging their contribution in an effort to maintain their momentum in the study.

189 The needs of the participants were taken into account, in terms of the measures used and the format of the intervention, so as to maintain their engagement. The self-help format and brief nature of the intervention was considered to facilitate engagement. Weekly contact with the researcher allowed participants’ needs to be monitored throughout the process, with support offered to those who had any questions or found any part of the process distressing.

2.5.3 Potential risks for researcher and associated risks for the study. This study was not considered to pose any risks to me as a researcher.

However, in case any harm occurred, it was agreed that support may be obtained from my research supervisors if required. One potential risk of the study related to attrition, however, to help with this, a decision was made that once data had been provided it would remain in the study if participants did not wish to withdraw it within the two-week window. It was also hoped that

reimbursing participants for their time would help counteract potential retention issues.

2.5.4 Confidentiality and data protection. All information obtained for the purposes of the study was treated with confidentiality. This study followed guidance advocated by the Data Protection Act (1998). Participants were required to develop their own identifiable code and password. The identifiable code was used to correspond with their measures and to identify their data in electronic databases. In order to ensure confidentiality, participants who chose to complete their measures online were each assigned a unique link to their set of measures which could only be accessed with the password they devised.

Codes were kept separately from study information to allow

confidentiality. The laptop used for data storage and the IRAP was password protected. In line with the Data Protection Act (1998), all data were retained in a lockable filing cabinet and stored at the University of Lincoln. Identifiable data (e.g., consent forms, participant names) were kept separately to anonymised data (measures, interviews, notes). Any electronic data were stored on an encrypted memory stick and on a password protected laptop. Access to the information was limited to the researcher and the administrator of the University of Lincoln (who filed it), but could be viewed by research supervisors and

relevant regulatory authorities, if required. All research data will be retained for

190 seven years following the completion of the study and then destroyed securely in accordance with university procedure. A confidential electronic record of participants’ details (e. name, participant number and email address) was created to allow identification for follow-up. After completion of the follow-up phase, this document was destroyed.

2.6 Analysis

Data were analysed using Microsoft Excel software and PASW Statistics Version 18, where appropriate, on a password protected laptop. The analyses sought to investigate the differences between the repeated measures (explicit, implicit and behavioural) as well as draw comparisons between these across time. Response latency data from the IRAP was transformed into D-IRAP scores following guidance by Barnes-Holmes et al. (2010).

2.6.1 Information relating to RCI and CSC. As mentioned in the journal paper, RCI and CSC calculations for the self-report measures was conducted. Here these concepts are briefly defined. Reliable change relates to the degree to which change occurs beyond the probability of variability of the measure, whereas CSC is the clinical cut-off or threshold an individual must cross to reach clinical change (Jacobson & Truax, 1991). Employing RCI and CSC criteria allows participants to be classified into one of four outcomes post-intervention (see Table 14; Davies & Sheldon, 2011). The formulas for

calculating RCI and CSC are outlined in Table 15.

Table 14.

Clinical and reliable criteria descriptions

Possible outcome Definition

Clinically significant improvement;

“recovered”

Improvement that achieves both RCI and CSC criteria

Reliable improvement; “improved” Improvement that achieves RCI but not CSC criteria

“No change” Change is within the expected range

Reliable deterioration; “deteriorated” Deterioration that achieves RCI criteria but not CSC Clinically significant deterioration Deterioration that achieves both RCI and CSC

criteria

191 Table 15.

Example of RCI and CSC calculations for illustrative purposes*

RCI calculations

Standard error of the measurement (SeM): SD x (1 – r) = 0.74 x (1 – 0.87) = 0.27

Standard error of difference (SeDiff):  2 x (SeM x SeM) =  2 x (0.27 x 0.27) = 0.38 Reliable Change Index using the formula**:

(Post-treatment score – Pre-treatment score) / SeDiff

(4.5 – 2.5)/0.38 = 5.26

For reliable change this figure needs to be greater than ±1.96 Yes CSC calculations

(SD functional population x M dysfunctional population) + (SD dysfunctional population x M functional population) / (SD functional population + SD dysfunctional population)

(0.77 x 4.08) + (0.74 x 4.45) / (0.77 + 0.74) = (3.1416) + (3.293) / 1.51 = 6.4346 / 1.51 = 4.26

CSC achieved Yes

Note: * Formulas based on Jacobson & Truax (1991); example based on participant 6 pre and post treatment scores on the MAAS. **Positively scored questionnaire as higher scores indicate improvement. If the questionnaire was negatively scored, then the pre-treatment score is subtracted from post-treatment score.

2.6.2 Treatment fidelity check. As mentioned in the journal paper, the researcher conducted a weekly check-in with each participant to assess progress and answer any questions they had. These weekly telephone calls (Appendix K for protocol used as a prompt) were recorded and subset of them were checked for treatment fidelity to the ACT model by Two Trainee Clinical Psychologists. The two raters used a script developed by the author. Results are presented in the journal paper and extended results (section 3.8).

2.6.3 Additional analyses. Trend, slope and stability calculations on daily ACT measure were produced following guidance by Lane and Gast

(2014). Graphical depictions of the daily ACT measures were devised and a brief visual analysis was conducted. This method was chosen because graphical display of data may inform the effectiveness of the intervention (Morley & Adams, 1991) and so this information was used to supplement the conclusions drawn in the journal paper in relation to the second research question.

192 3. Extended Results

The journal paper provided an overview of the main findings of this study, and supplementary information is provided here; for example, information

relating to the demographics, the rationale for the norms used as reference data for the RCI and CSC calculations, a detailed interpretation of the IRAP, as well as information relating to the trend, level and stability information for the daily ACT measure. The results of all measures used have also been synthesised and tabulated according to the three research questions for each participant.

Due to following the narrative in the journal paper, the extended results have not been explicitly set out according to the three research questions. However, where relevant, data which related to a particular research question is

highlighted in the text.

3.1 Demographics

Table 16 contains the demographic information for the six participants in this study. All were female university students with ages ranging from 19 to 37 years (mean age of 27 years). The length of time for baseline for the six

participants ranged from seven to 17 days (mean baseline of 12 days).

Table 16.

Participant demographics

Participant Gender Ethnicity Age Occupation Marital status

Baseline length

1 Female White British 21 Student Single 7

2 Female White British 37 Student Married 12

3 Female Black British 20 Student Single 11

4 Female White British 36 Student Married 13

5 Female White British 29 Student Married 14

6 Female White British 19 Student Single 17