key: cord-0698255-h9nbtt2l authors: Jones, Emily J.; Howell, Joel A.; Tonta, Kate E.; Egan, Sarah J.; Hasking, Penelope A.; Boyes, Mark E.; McEvoy, Peter M.; Mazzucchelli, Trevor G. title: Guided Internet-Delivered Cognitive Behaviour Therapy for Perfectionism in a Non-Clinical Sample of Adolescents: A Study Protocol for a Randomised Controlled Trial date: 2020-08-27 journal: Internet Interv DOI: 10.1016/j.invent.2020.100342 sha: c5c5e981b20c8a6e981f8db8d85296636a74ce35 doc_id: 698255 cord_uid: h9nbtt2l Background Perfectionism is elevated across a range of psychopathologies and has shown to impede treatment outcomes. There is also evidence suggesting elevated perfectionism may contribute to the onset and maintenance of non-suicidal self-injury. There is a growing body of evidence suggesting that Internet-delivered cognitive-behavioural therapy for perfectionism reduces perfectionism and symptoms of psychological disorders and that reductions are maintained at 3-month and 6-month follow-up. There may also be reductions in non-suicidal self-injury, although no study has investigated this potential benefit. Given that associations between perfectionism and psychopathology are observed across both adults and adolescents, the need for the development of interventions targeting adolescents is essential for early intervention and prevention. Methods The present study will employ a randomised controlled trial to examine the efficacy of 8-week guided Internet-delivered cognitive-behavioural therapy for perfectionism in adolescents compared to a waitlist control group. The primary outcome is perfectionism, and secondary outcomes include symptoms of psychological disorders, well-being, and non-suicidal self-injury. Outcomes will be assessed at pre-intervention, post-intervention, 1-month follow-up, 3-month follow-up, and 6-month follow-up. A minimum of 240 participants will be recruited online through social media, Australian universities, and schools across Australia. Generalised linear mixed models will be used to test for changes in outcomes between the intervention group and the waitlist control. Discussion The outcomes of this trial will contribute to the literature on perfectionism and psychopathology in adolescents, as well as the efficacy of guided Internet-delivered interventions for adolescents. Trial registration The trial was registered on the 20th of June 2019 at the Australia New Zealand Clinical Trials Registry (ACTRN12619000881134). Trial Status This is protocol version 1.0. Participant recruitment began on 31 July 2019 and is still actively running with an anticipated completion date in the fourth quarter of 2020. at 12-month follow-up [13] . To date, only one study has examined the efficacy of ICBT-P in a sample of adolescents [17] . Researchers examined the efficacy of unguided ICBT-P compared to an active treatment condition, and a waitlist control group in preventing eating disorder onset in a sample of adolescent females [17] . Results showed that unguided ICBT-P was efficacious in reducing clinical perfectionism, and that reductions were maintained at 6month follow-up [17] . While the findings provide evidence for the utility of Internetdelivered interventions for the prevention of eating disorders in adolescents, there has been no investigation of the efficacy of guided ICBT-P across a broad range of outcomes in a general sample of adolescents. This study will be a two-arm randomised controlled trial comparing the efficacy of guided ICBT-P with a waitlist control in adolescents aged 13-to 18-years. The first aim of the present study is to examine the efficacy of ICBT-P in reducing perfectionism and symptoms of eating, mood, and anxiety disorders, as well as increasing well-being. It is predicted that the intervention group will report significantly greater pre-post, 1-month, 3month, and 6-month follow-up decreases in perfectionism, eating disorder symptoms, depression, anxiety and increases in well-being, compared to the wait-list group. A second exploratory aim of this research is to explore the impact of ICBT-P in reducing non-suicidal self-injurious thoughts and behaviours, and explore the potential mechanisms by which this may occur (i.e., repetitive negative thinking and attentional allocation). It is predicted that the intervention group will report significantly greater pre-to post, 1-month, 3-month, and 6-month follow-up decreases in non-suicidal self-injurious thoughts and behaviours compared to the waitlist group. The trial will be conducted in accordance with the National Statement on Ethical J o u r n a l P r e -p r o o f Conduct in Human Research (2007, revised 2018) . The study protocol follows recommendations of the SPIRIT 2013 Checklist for clinical trial protocols. The registration process (including obtaining informed consent) and the entire study will be conducted online at overcomingperfectionism.com.au. Inclusion criteria include: between 13-to 18-years of age, able to read and write in English, and currently living in Australia. If participants are identified with a high or imminent risk of suicide they will be excluded from the study, and an adverse events plan will be followed to ensure their safety. Any individual excluded from the study on this basis will be able to take part in the study at a later time. Participants will be recruited through social media advertising and at a local university [blinded for review], and through private schools across Australia. Given previous clinical trials for perfectionism include larger proportions of female participants compared to males [12, 14] , measures will be taken to increase the number of male participants. This will include targeted paid social media advertising, as well as active recruitment through all-male schools. An a-priori power analysis was conducted to estimate the sample size using G*Power (Version 3.1) [18] . Previous studies that have conducted randomised controlled trials of Internet-delivered interventions for perfectionism, and that used a primary outcome measure of perfectionism, have found moderate to large effect sizes [11, 17] . To achieve 80% power at an alpha level of 0.01 with two groups and four time points, the required sample size is 180 (90 per group). The alpha level was adjusted to account for the separate GLMM analyses being conducted on each of the outcomes. Similar interventions in adult populations reported 20% attrition [13] , and guided internet interventions for anxiety and depression among adolescents reported 5%-15% attrition at post-assessment and 28-33% attrition at follow-up J o u r n a l P r e -p r o o f assessment [19, 20] . Approximately 33% attrition is therefore expected. To account for 33% attrition 240 participants (120 per group) will be recruited. All recruitment materials will include a link to the study website where potential participants will read the information sheet and complete an online consent form. Participants will be treated as mature minors. Their capacity to provide informed consent will be evaluated through the completion of a five-item questionnaire assessing their understanding of what is involved with participation. Those unable to answer the questions correctly will require parent/caregiver consent before they can participate. Participants who provide consent will be contacted by telephone to briefly discuss the study and to be screened for the exclusion criteria. All participants will be screened for suicidality before taking part in the study. This will be done using the Columbia Suicide Severity Rating Scale (a well-validated and commonly used measure appropriate for individuals aged 13+ years) [21] . If an individual scores 4 or higher (indicating active suicidal ideation with some intent to act on these thoughts), a complete suicide risk assessment will be conducted. The participants' risk score will be calculated using the assessment tool. An adverse events plan has been developed to provide a structured approach to managing risk and will be followed for those with a high or imminent risk of suicide. These individuals will be welcome to take part in the study at a later time at a reduced risk of suicide. Participants in the intervention group will be informed that there will be eight modules in the program and they should aim to complete one per week for eight weeks. Participants randomly allocated into the control group will be informed and reminded that they are welcome to complete the program once all data has been collected. All participants will be asked to complete a series of measures at pre-intervention, post-intervention, 1-month follow-up, 3-month follow-up, and 6-month follow-up. Weekly emails and text messages will J o u r n a l P r e -p r o o f be sent to participants to remind them to complete the sessions and assessments at each time point. At any time during the intervention and after completing the program, participants have the right to withdraw without the obligation to provide their reasons, as stated in the during the consent process. Figure 1 illustrates a flow chart of participant group allocation. After participants have been screened and deemed eligible for the study, they will be assigned a participant ID number and registered as participants for the trial. Once participants have completed the baseline measures, they will be allocated into one of two groups (either the intervention group or the waitlist control). Random Allocation Software version 1.0 [22] will be used to randomly allocate participants into either the intervention group or control group using block randomisation procedures to ensure an equal number of participants in both conditions (fixed blocks of 4). Participant allocation will not be concealed as the researchers are required to provide personalised feedback to participants in the intervention group. Self-report measures of perfectionism, symptoms of eating, mood, and anxiety disorders, repetitive negative thinking, and attentional control will be administered at four time points: at baseline (before the intervention begins), post-intervention (immediately after the completion of module 8), 1-month follow-up, 3-month follow-up, and 6-month follow-up. Self-report measures of well-being and non-suicidal self-injury will also be administered at these timepoints and after each module (i.e., weekly) due to the fluctuating nature of nonsuicidal self-injury and psychological well-being. Measures of self-injury will only be J o u r n a l P r e -p r o o f Journal Pre-proof administered for those who indicate they have previously had thoughts about engaging in self-injury pre-intervention. Participants randomly allocated to the intervention group will also complete a measure of treatment adherence and credibility at the end of each module. See Table 1 for an overview of the assessment schedule. J o u r n a l P r e -p r o o f The primary outcome measure is the Clinical Perfectionism Questionnaire (CPQ) [23] . The CPQ is a 12-item self-report measure that assesses levels of clinical perfectionism over the past month [23] . Items are scored using a 4-point Likert scale ranging from 1 (not at all) to 4 (all the time). There is evidence for a two-factor model of the CPQ with a perfectionistic strivings factor and concerns over mistakes factor. Recent evidence, however, has suggested that one factor provides the best fit [24] . This single-factor CPQ has demonstrated acceptable internal consistency in a clinical sample ( = .87) [24] . The Eating Disorder Examination Questionnaire (EDE-Q) is a 28-item self-report scale that measures specific eating psychopathology over the past 28 days [25] . The EDE-Q has demonstrated reliability and validity in samples of adolescents [26] , and has been used for online interventions in samples of adolescents [27, 28, 17] . Excellent internal consistency of the global EDE-Q score has been reported in a female adolescent sample (α = .96) [17] . The Revised Child Anxiety and Depression Scale (RCADS) is a 47-item child selfreport scale that measures the frequency of symptoms of anxiety and depression in people aged 8-to 18-years [29] . Several studies have demonstrated support for the RCADS in samples of non-clinical adolescents [29, 30] . Excellent internal consistency for the major depressive disorder subscale (α = .88) and excellent internal consistency for the total anxiety scale (α = .94) has been reported in a sample of female adolescents aged 13to 19-years [17] . The Inventory of Statements About Self-Injury (ISAS) [31] , will be used to assess the history, frequency, and type of NSSI engaged in. Participants report if they have ever engaged in NSSI, and then rate the frequency of 12 common NSSI behaviours (e.g., cutting, self-battery, and burning). The measure also assesses the context in which NSSI occurs (e.g., pain during self-injury). A mean test-retest correlation of .68 suggests good reliability for the J o u r n a l P r e -p r o o f behavioural scales across a 12-month period [32] . This measure has been used in previous research with similar populations, aged 13-to 24-years [33] with demonstrated reliability. In addition to the ISAS, three further questions will be asked to evaluate thoughts about selfinjury, as well as the intensity of thoughts and behaviours. The participants will be presented with a definition of self-injury, and asked if they have had thoughts about engaging in selfinjury in the past week. If participants endorse thoughts of self-injury, they will be asked about the intensity of those thoughts. Responses will be rated from 1 (passing thoughts) to 7 (intense thoughts about engaging in self-injury). If participants indicate that they have engaged in non-suicidal self-injurious behaviours in the past week, they will be asked about the severity of that behaviour on average and during the most intense episode. Responses will be rated from 1 (no physical damage) to 7 (emergency medical care required). The General Health Questionnaire-12 (GHQ-12) is a 12-item self-report measure of well-being [34] . The GHQ-12 has demonstrated good reliability and validity in an Australian sample of Adolescents (aged 11-to 15-years) [35] . The Repetitive Thinking Questionnaire -Short (RTQ) [36] is a 10-item measure which assesses repetitive thinking about one's negative experiences. The RTQ requires individuals to consider how they typically feel when distressed and then rate how true each of the 10 items are of their experience after the distressing situation. The RTQ has demonstrated good internal consistency in community samples (α = .89) and has demonstrated convergent validity with measures of negative affect and psychological distress [36] . There is evidence to suggest that the RTQ performs equally as well in adolescents aged 13-to 17-years [37] . The Attentional Control Scale (ACS) [38] will be used to assess voluntary control over attention. This measure contains 20 items in two subscales: attentional focusing (9 items) and attentional shifting (11 items). There is psychometric evidence which supports the which indicates the content is readable by someone between the 7 th and 8 th grade. Reliability and validity checks will be performed once data collection has been completed. The Credibility/Expectancy Questionnaire (CEQ) is a 6-item measure that assesses treatment credibility and expectancy [40] . Items are scored using a 9-point Likert scale. The CEQ has demonstrated excellent internal consistency [40] . Adherence will be measured weekly using the feedback questionnaire which has four questions measuring compliance in completing the modules and is derived from a compliance measure for treatment of bulimia nervosa [41] . Analytics will be used to gather information on length of time taken to complete modules, which modules are accessed, and drop-out point. The present Internet-delivered perfectionism program is based on the second edition of the book Overcoming Perfectionism: A self-help guide using cognitive behavioural techniques [42] . The program has two main components: psychoeducation, and learning new skills to overcome perfectionism. The program has been reviewed and modified by Dr Sarah Egan and Assistant Prof Hunna Watson, both of whom are experts in the area of perfectionism and cognitive-behavioural therapy, to create an eight-session interactive online program that is suitable for adolescents. Participants will be asked to complete one module J o u r n a l P r e -p r o o f per week over the course of eight weeks. Participants will have access to a list of support services should they experience any psychological discomfort or harm during or after the study. See Table 2 for an outline of the intervention modules. The intervention will be guided in that participants will receive brief weekly feedback on completed homework tasks. In line with previous ICBT-P studies [e.g. 13] this feedback will take about 5 minutes per participant and be provided within 48-hours of receipt of homework via email. Participants will be given the opportunity to submit one worksheet/activity from each module of the program. The feedback responses are scripted, and will allow for a small degree of personalisation for each participant. Once data collection is complete, it will be downloaded into SPSS and Generalised Linear Mixed Models (GLMM) will be used to test for changes in outcomes between the intervention group and the waitlist control group. All statistical analyses will be based on the intention-to-treat principle. The present GLMM will include one nominal random effect outcome independently of the others will inflate the family-wise error rate and the per-test α will, therefore, need to be corrected to control the inflation. To retain statistical power, Bonferroni adjusted alpha levels will be applied within groups of conceptually related outcomes rather than across the entire set of outcomes. A GLMM will assume a normal probability distribution for the outcome and link it to the fixed effects specified in the model (group, time, group-time interaction) [43] . If the outcome does not have a normal distribution, then the parameter estimates of the covariance matrix will be computed with robust statistics. The participants will be randomised into either the intervention group or the control group to maximise the chance they are matched in terms of potentially confounding demographic variables. The groups will be checked for any confounding demographic variables which will be controlled for in all analyses. Participant attrition may impact on whether the groups are matched, therefore potential confounding demographic variables will be identified and statistically controlled in the GLMM analysis. GLMM is less sensitive to participant attrition and does not rely on participants providing data at each assessment point. The GLMM will analyse all data, regardless of whether participants completed the post-intervention assessment and the follow-up assessments. This reduces sampling bias and the need to replace missing data. Reliable change indices (RCI) will be used to determine whether the intervention produces a clinically important change. Absolute reliable changes less than or equal to 1.96 will indicate no change, and absolute reliable changes indices greater than 1.96 will indicate a reliable change between the preintervention and post-intervention scores [44] . Reliable deterioration of symptomology will be assessed and defined by the presence of a negative clinically reliable change. The aim of the present study is to investigate whether guided Internet-delivered cognitive-behavioural therapy for perfectionism is efficacious in reducing perfectionism, J o u r n a l P r e -p r o o f symptoms of anxiety, mood, and eating disorders, non-suicidal self-injury, and increasing well-being in adolescents. To our knowledge, this is the first randomised controlled trial to examine the efficacy of guided Internet-delivered cognitive-behavioural therapy for perfectionism in a community sample of adolescents to include males. Furthermore, this study will be the first experimental exploration of the impact of treatment of perfectionism on non-suicidal self-injury thoughts and behaviours. The findings from this study will contribute to the literature on perfectionism and psychopathology in adolescents, as well as develop our understanding of factors related to the onset and continuation of psychological symptoms. The findings may also provide insights into the mechanisms maintaining non-suicidal selfinjury. Due to the online nature of the intervention, a limitation of the present study is that no information regarding the clinical diagnoses of participants will be collected. Therefore, it will not be possible to draw conclusions regarding any reductions in the severity of clinical diagnoses. Nonetheless, findings from the present study could help with identifying adolescents at high risk of developing psychological disorders and inform on the utility of a selective prevention approach for reducing symptoms and the future onset of disorders into late adolescence and early adulthood. Identifying individuals at risk of developing psychological disorders is especially important during adolescence given that many psychological disorders emerge during this time of development [45] . Early intervention and prevention is therefore essential for reducing the burden associated with psychological disorders during adolescence, as well as preventing the progression of psychopathology into adulthood [46] . Research suggests early intervention and prevention has long-lasting effects on overall health and wellbeing and is, therefore, the preferred approach over intervention once clinical diagnoses are present [46] . Although the aim of the present study is not to examine the prevention effects of Internet- interventions for perfectionism in adults [11, 15] , there is currently a limited evaluation of various levels of support in Internet-delivered interventions for perfectionism in adolescents. The impact of the coronavirus pandemic may include increased participant distress. Due to lockdown restrictions in Australia, adolescents may experience increased distress in response to limited leisure activities, reduced peer interaction, and overall loss of daily routine and structure [47, 48] . This varying impact of coronavirus will be difficult to capture due to different levels of lockdown across the country. The inclusion of a control group in the J o u r n a l P r e -p r o o f study design will increase the likelihood that between-group differences observed will highlight intervention effects rather than external factors (including COVID-19-related distress). 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