Overcoming Perfectionism: A Randomised Controlled Trial of an Online CBT Based Guided Self-help Intervention

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effectiveness of CBT based online guided self-help intervention for perfectionism at reducing symptoms of perfectionism and Axis I disorders post-treatment and at six-month follow-up.

Detailed Description
-----------------
Perfectionism is elevated across, and increases risk for a range of Axis I disorders, as well as having a direct negative effect on day to day function. A growing body of evidence shows that cognitive behavioural therapy (CBT) reduces perfectionism and Axis I disorders, with medium to large effect sizes. Given the increased desire for online interventions to facilitate access to evidence-based therapy, web-based CBT self-help interventions for perfectionism have been designed. Existing interventions have not included personalised guidance which has been shown to improve outcome rates. The purpose of this study is to assess the effectiveness of CBT based online guided self-help intervention for perfectionism at reducing symptoms of perfectionism and Axis I disorders post-treatment and at six-month follow-up. A randomised controlled trial method is employed, comparing the treatment arm (online guided self-help) with a waiting list control group. Outcomes are examined at three time points, T1 (baseline), T2 (post-intervention at 12 weeks), T3 (follow-up at 24 weeks). Participants will be recruited through universities, online platforms, and social media, and if eligible will be randomised using an online automatic randomiser.

Official Title
-----------------
Overcoming Perfectionism: A Randomised Controlled Trial of an Online CBT Based Guided Self-help Intervention

Conditions
-----------------
Perfectionism

Intervention / Treatment
-----------------
* Other: online guided self-help intervention for perfectionism


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be 18 or over, with no upper age limit. Score one standard deviation above published norms on the 'Concern over mistakes' subscale of the Frost Multidimensional Perfectionism Scale (Frost, Marten, Lahart, & Rosenblate, 1990), i.e. a score of ≥ 29 (Flett, Sawatzky, & Hewitt, 1995). Be fluent in English. Exclusion Criteria: - They report suicidal thoughts or intent prior to commencement of the intervention.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online guided self-help intervention<br>CBT based online guided self-help intervention. Intervention can be found at www.overcomingperfectionism.co.uk | Other: online guided self-help intervention for perfectionism<br>* CBT based online guided self-help intervention for perfectionism based on CBT manual for treatment of perfectionism, Cognitive Behavioural Treatment of Perfectionism by Sarah Egan, Tracy Wade, Roz Shafran and Martin Antony<br>* Other names: Overcoming Perfectionism;|
| No Intervention: Control<br>No intervention. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frost Multidimensional Perfectionism Scale (Frost et al., 1990) | This self-report measure consists of 36 items grouped into six subscales. Participants respond on a five point scale ranging from 1 = strongly disagree to 5 = strongly agree. The measure has been found to be both reliable and valid for use with non-clinical and clinical populations (Frost et al., 1990; Hewitt & Flett, 1991; Hewitt, Flett, Turnbull-Donovan, & Mikail, 1991). Participants will be considered eligible for inclusion in the study if they score one standard deviation above published norms on the Concern over Mistakes subscale, i.e. a score of ≥ 29. This measure has been amended to reflect participants experience over the past month allowing us to measure change. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obsessive-Compulsive Inventory - Revised (OCI-R) (Foa et al., 2002) | The OCI-R, a shortened version of the Obsessive-Compulsive Inventory, assesses symptoms of OCD. The measure consists of 18 items (e.g. I frequently have get nasty thoughts and have difficulty in getting rid of them). On a five point scale, respondents rate how distressed or bothered they have been in the past month by the symptom described, with responses ranging from Not at all to Extremely. It has been found to have good validity and reliability in both clinical and non-clinical samples (Abramowitz & Deacon, 2006; Foa et al., 2002; Hajcak, Huppert, Simons, & Foa, 2004; Huppert et al., 2007). | 6 months | 
| Eating Disorder Examination-Questionnaire (EDE-Q) (C. G. Fairburn, 1994) | The EDE-Q assesses for symptoms of the eating disorders: Anorexia Nervosa (AN), Bulimia Nervosa (BN), Binge Eating Disorder (BED) and sub-threshold variants. The measure consists of 28 items rated on a seven point scale appropriate to the item: number of days a symptom has been experienced over the past month, ranging from no days to every day; and for remaining questions (e.g. How dissatisfied have you been with your weight?) responses ranging from Not at all to Markedly. It has been found to have good reliability, and has been validated for use among clinical and community samples (Aardoom, Dingemans, Op't Landt, & Van Furth, 2012; Carter, Stewart, & Fairburn, 2001; J. M. Mond, Hay, Rodgers, Owen, & Beumont, 2004; Jonathan M Mond et al., 2008; Reas, Grilo, & Masheb, 2006). | 6 months | 
| Depression, Anxiety and Stress Scales (DASS) (Lovibond & Lovibond, 1996) | The DASS is a 42 item self-report measure of depression, anxiety and stress (e.g. I found myself getting upset by quite trivial things), rated on a four point scale ranging from Did not apply to me at all to Applied to me very much or most of the time. It has been shown to be reliable and has been validated for use among clinical and community samples (Brown, Chorpita, Korotitsch, & Barlow, 1997; Crawford & Henry, 2003; Page, Hooke, & Morrison, 2007). | 6 months | 
| Vancouver Obsessional Compulsive Inventory - Mental Contamination Scale (VOCI-MC) (Radomsky, Rachman, Shafran, Coughtrey, & Barber, 2014) | The VOCI-MC is a self-report measure that assesses symptoms of mental contamination. The measure consists of 20 items (e.g. Often I look clean but feel dirty), rated on a five point scale ranging from Not at all to Very much. It has been shown to be reliable and valid for use among clinical and community samples (Coughtrey, Shafran, Knibbs, & Rachman, 2012; Coughtrey, Shafran, & Rachman, 2013; Radomsky et al., 2014). | 6 months | 
| Clinical Perfectionism Questionnaire (CPQ; C. Fairburn et al., 2003a) | This self-report measure consists of 12 items (e.g. Have you pushed yourself really hard to meet your goals? and Have you raised your standards because you thought they were too easy?). Participants respond on a four point scale ranging from 1 = not at all to 4 = all the time. This measure of clinical perfectionism was created by Fairburn, Cooper and Shafran at the University of Oxford, and has been found to have good reliability and validity in two community samples and an ED sample; participants will be considered eligible for inclusion if they score similarly to this psychiatric population (i.e. a score of ≥ 29) (Egan, Shafran, et al., 2014). This measure has been amended to reflect participants experience over the past week, allowing us to monitor change on a weekly basis. | 6 months |