Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000128594
Ethics application status
Approved
Date submitted
28/01/2015
Date registered
11/02/2015
Date last updated
16/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial Investigating Online Cognitive Behavioural Therapy for Perfectionism to Prevent Eating Disorders
Scientific title
A Randomised Controlled Trial Investigating the Effects of Online Cognitive Behavioural Therapy for Perfectionism, Online Cognitive Behavioural Therapy for Stress, and Waitlist Control to Prevent Eating Disorders in Australian Females ages 14 to 19.
Secondary ID [1] 286062 0
Nil known
Universal Trial Number (UTN)
U1111-1166-6325
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eating disorders 294047 0
depression 294048 0
anxiety 294049 0
low self-esteem 294050 0
Condition category
Condition code
Mental Health 294352 294352 0 0
Eating disorders
Mental Health 294353 294353 0 0
Depression
Mental Health 294354 294354 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The present study aims to examine the effectiveness of an online prevention program for eating disorders which addresses clinical perfectionism. The proposed study is a Randomised Controlled Trial (RCT) targeting female adolescents aged 14 to 19 years old. Participants will be randomized into one of three groups (online guided self-help cognitive behaviour therapy for perfectionism [CBT-P], online guided self-help cognitive behaviour therapy for nonspecific stress management [CBT-S] or waitlist control [WLC]).
The intervention is CBT-P, which is based on an empirically supported and theoretically driven material “Overcoming Perfectionism: A self help guide using cognitive behavioural techniques” (Shafran, Egan & Wade, 2010).
CBT-P consists of 8 sessions that are completed over 4 weeks (2 sessions per week) with each session taking approximately 30minutes to 1hour. To monitor adherence to the intervention, participants are sent a generic weekly sms reminders to log in to the program "Hi (name), please login this week to the beyoutiful program to complete sessions x and y (session number). Thank you!". Participants who have not provided a mobile phone number will be contacted via email. If unresponsive, participants will be contacted by the phone number they have provided on their consent forms.
Intervention code [1] 291051 0
Prevention
Intervention code [2] 291113 0
Behaviour
Comparator / control treatment
The effects of CBT-P will be compared against a nonspecific CBT-S and a waitlist control [WLC]).

The CBT-S program which serves as an active control will be based on a published CBT self-help manual for stress “Overcoming Stress: A self-help guide using cognitive-behavioural techniques” (Brosan & Todd, 2009). As with CBT-P, CBT-S consists of 8 sessions that are completed over 4 weeks (2 sessions per week) with each session taking approximately 30minutes to 1hour. To monitor adherence to the intervention, participants are sent a generic weekly sms reminders to log in to the program "Hi (name), please login this week to the beyoutiful program to complete sessions x and y (session number). Thank you!". Participants who have not provided a mobile phone number will be contacted via email. If unresponsive, participants will be contacted by the phone number they have provided on their consent forms.

The waitlist control will not undergo any treatment from pre-treatment to 6 months follow-up. After 6 months, the waitlist control group are given the option to participate in the program of their choice - either CBT-P or CBT-S
Control group
Active

Outcomes
Primary outcome [1] 294148 0
Primary Outcome: Prevention effect on eating disorders
(a) Eating disorder symptoms as measured by Eating Disorder Examination Questionnaire (EDE-Q; Fairburn & Beglin)

Timepoint [1] 294148 0
From baseline to post test, 3 months follow up and 6 months follow up
Primary outcome [2] 294149 0
(b) Compulsive exercise symptoms as measured by the Compulsive Exercise Test (CET; Taranis, Touyz, & Meyer)
Timepoint [2] 294149 0
From baseline to post test, 3 months follow up and 6 months follow up
Primary outcome [3] 294150 0
(c) The proportion of healthy individuals at baseline who go on to develop subclinical and clinical eating disorders from baseline (as measured by EDE-Q)
Timepoint [3] 294150 0
From baseline to post test, 3 months follow up and 6 months follow up
Secondary outcome [1] 312623 0
Prevention of Depression
(a) Depressive symptoms from baseline as measured by depression scores on Revised Child Anxiety and Depression Scales (RCADS; Chorpita et al., 2000)
Timepoint [1] 312623 0
From baseline to post test, 3 months follow up and 6 months follow up
Secondary outcome [2] 312624 0
Prevention of Depression
(b)The proportion of healthy individuals at baseline who go on to develop subclinical or clinical thresholds of depression (according to the scoring guidelines on RCADS
Timepoint [2] 312624 0
From baseline to post test, 3 months follow up and 6 months follow up
Secondary outcome [3] 312625 0
Prevention of Anxiety
(a) Anxiety symptoms from (as measured by anxiety scores on RCADS)
Timepoint [3] 312625 0
From baseline to post test, 3 months follow up and 6 months follow up
Secondary outcome [4] 312626 0
(b) The proportion of healthy individuals at baseline who go on to develop subclinical or clinical thresholds of anxiety (according to the scoring guidelines on RCADS)
Timepoint [4] 312626 0
From baseline to post test, 3 months follow up and 6 months follow up
Secondary outcome [5] 312627 0
Effect on self-esteem assessed by Rosenberg Self-Esteem Scale (RSES; Rosenberg, 1965)
Timepoint [5] 312627 0
From baseline to post test, 3 months follow up and 6 months follow up

Eligibility
Key inclusion criteria
Inclusion criteria are:
1. Female, 14-19 years old
2. Internet access either at home or at a location where regular use is possible (e.g. school, library)
3. Adequate English language skills
4. Access to a General Practitioner who would be able to monitor their physical health (in the event that they are at risk of suicidality/eating disorder symptoms, anxiety or depressive symptoms, we recommend them and their caregivers to seek further help at their GP
5. Body Mass Index (BMI) above or equal to 17kg/m2.

It is not necessary for participants to have any symptoms/characteristics of perfectionism to be eligible. Anyone who is interested in participating and meets the inclusion criteria are welcome to join.
Minimum age
14 Years
Maximum age
19 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Currently undergoing psychological therapy
2. Current diagnosis of a clinical Eating Disorder

Adolescents who express an interest in participating in the study will be screened for eating disorders using the SCOFF questionnaire (Morgan, Reid, & Lacey, 1999), suicidality using the B1 suicidality module of Mini International Neuropsychiatric Interview Kid (MINI-Kid; Sheehan et al., 1998).

Interested adolescents cannot endorse two or more items on the SCOFF. Adolescents who endorse two or more items will be excluded from the study. They/their caregivers (if under 18) will be notified and advised to bring their adolescent to their local GP for a full assessment. The SCOFF is a screening tool for eating disorders with five questions addressing the core features of Anorexia Nervosa and Bulimia Nervosa. Interested adolescents cannot endorse any of the three questions on the B1 suicidality module on the MINI-Kid in the past 28 days. If they do, they/their caregivers (if under 18) will be notified and advised to bring their adolescent to their local GP for a full assessment and they are excluded from the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (Random Allocation Software).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N.A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations
Each hypothesis predicted a Group x Time interaction. An a priori power analysis was conducted based on data from previous studies that assessed the efficacy of CBT–P, with large effect sizes (d = 1.36-1.90) found with small sample sizes (Riley et al., 2007; Steele et al., 2013). The highest attrition rate of 50% noted in online formats of randomised controlled trials was used (Christensen et al., 2009). An a priori power analysis was used to estimate the sample size range by using the effect sizes. To achieve 80% power at an alpha level of 0.01, with three groups, using a moderate Group x Time interaction (f = .3) at the Bonferroni adjusted alpha power level of .01, the required total sample size was 57 (G*Power 3.1, Faul, Erdfelder, Lang, & Buchner, 2009). After adjusting for attrition rate of 50%, the estimated total sample to be recruited was 86. As mentioned, GLMM did not rely on participants providing data at every assessment point; GLMM used all data present at each assessment point, thereby reducing the impact of subject attrition on statistical power (Elobeid et al., 2009).

Generalised Linear Mixed Models (GLMM) was used to test for differential changes in outcomes between intervention and control groups, and effect sizes to measure the efficacy of interventions. GLMM was chosen because it is able to accommodate the violations of normality and homogeneity of variance, and sphericity. It is robust to unequal group sizes, and most importantly, it is less sensitive to participant attrition which is common in interventions because it does not rely on participants providing data at every point, thereby optimising statistical power (Elobeid et al., 2009).

A series of GLMMs, one for each of the six outcome measures, was developed in order to test for treatment and prevention effects. The GLMMs were implemented through SPSS’s (Version 22) GENLINMIXED procedure. The GLMM represents a special class of regression model. The GLMM is “generalised” in the sense that it can handle outcome variables with markedly non-normal distributions. The GLMM is “mixed” in the sense that it includes both random and fixed effects. Each of the present GLMMs included one nominal random effect (participant), one nominal fixed effect (group: CBT-P, CBT-S, waitlist control), one ordinal fixed effect (pre-test, post-intervention, 3-month follow-up, 6-month follow-up), and one 2-way interaction (Group x Time).

Effect size and clinically significant change. To supplement statistical hypotheses testing, effect sizes and clinically significant changes were computed. Pre-intervention, post- intervention, 3-month follow-up and 6-month follow-up intervention effect sizes were calculated using Cohen’s d (Cohen, 1988) for the three groups. Cohen’s d could not be used to measure interaction effects, and partial eta squared was used instead. The formula is eta squared = F/(F+df2) where .01 = small, .06 = moderate, .14+ = large. Cohen’s d (GLMM2) was calculated for post-hoc least significant difference (LSD) tests, conducted to locate the source of the significant interactions (i.e., pre- to post-intervention, pre-intervention to 3-month follow-up, pre-intervention to 6-month follow-up). Cohen’s d was estimated from the LSD t-values using the following formula, d = 2t/sqrt(df). Conventions for Cohen’s d were used, .2 = small, .5 = moderate, .8 = large (Cohen, 1988).

Clinically significant and reliable change indices were used to determine whether the intervention groups produced a clinically important change. Jacobson and Truax (1991) methodology was used to assess the reliability and clinical significance of each participant’s pre- to post-treatment and pre-treatment to follow-up change scores. A clinically significant change had to first be statistically reliable, which was assessed with the reliable change index (RCI; Jacobson et al., 1986). The RCI was the degree to which the person changed on the outcome variable divided by the standard error of difference (S diff) between the pre-treatment (X1) and post-treatment (X2) scores, Absolute RCIs less than or equal to 1.96 indicate no change. When the absolute value of the RCI exceeded 1.96, it was likely that the pre- to post-treatment change score reflected a real or reliable change (Jacobson & Truax, 1991).
Once the RCI had been calculated to determine that the intervention had produced a statistically reliable change in a particular client, it was important to determine whether the change were clinically significant. Testing for clinical significance involved classifying changes in symptom severity in categories of “recovered”, “improved”, “unchanged”, or “deteriorated” (Jacobson & Truax, 1991). Using the classification system required cut-off points to be calculated. Three possible cut-off points were suggested in this system: Cut-off point a was where the post-treatment score fell at least two SDs beyond the mean of a dysfunctional population. Cut-off point b was where the post-treatment score fell within two SDs of the mean for the functional population. Cut-off point c is where the post-treatment score placed that client closer to the mean of the functional population than it did to the dysfunctional population.
Jacobson and Traux (1991) suggested that cut-off point c was the most preferable to use when norms are available for both the dysfunctional and functional populations.
The clinical cut-offs were used in conjunction with the RCI. A classification of “recovered” was used when the RCI was greater than 1.96 and their post treatment score was in the functional range. If the RCI was greater than 1.96, and the score moved towards the functional mean but still fell within the clinical range, it was classified as “improved”. When neither conditions were met, the classification of “unchanged” was used. When the RCI was greater than 1.96, but the score had moved away from the functional mean and toward the clinical population, a classification of “deteriorated” was used. Each individual’s scores on the respective outcome variables were tested for reliable change and clinically significant change, and chi-square tests were conducted to determine whether the three groups differed in proportions of cases showing reliable change and clinically significant change.
While there is clear evidence of a two-factor structure of the CPQ, different researchers had included different items in each of the two factors (cf. findings from Chapter 2, Dickie et al., 2012; Egan et al., 2016; Stoeber & Damian, 2014). For this study, the data from Chapter 2 with Perfectionistic Strivings (CPQ Factor 1); M = 13.19, SD = 3.40 and CPQ Factor 2 (Perfectionistic Concerns); M = 9.69, SD = 2.49 were used to calculate clinically significant change. Because these data were obtained from a functional population, and no alternate data from a dysfunctional population was currently available, cut-off point b was used. As discussed in the Measures section, the empirical derived threshold = 2.30 for the global score (Mond et al., 2004) was a suitable, but not ideal, cut-off for clinically significant eating disorder psychopathology for the sample. To measure clinically significant changes on the RCADS for anxiety and depression, the study adhered to the manual (Chorpita et al., 2000) where a T-score of = 70 indicated a clinical threshold of a disorder for females aged 14 to 18 years old. To measure clinically significant changes on the RSES, the study used the cut-off of low self-esteem of = 15 as indicative of clinically significant low self-esteem ( Rosenberg, 1965). No alternate community or clinical data for females aged 14 to 19 years with eating disorders were available that used the RSES scoring of 0 to 30, as recommended in Rosenberg (1965).

Z-score test for two population proportions.
Several researchers in the prevention field have examined clinically significant changes where they compared the migration of proportions of participants who “recovered”, “improved” and “deteriorated” overtime (Shochet et al., 2001; Stice et al., 2011b; Wilksch et al., 2008). The present study adopted the methodology of several prevention studies that compared the proportions of participants who “recovered”, “improved” or “deteriorated” over time and included both prevention and treatment effects (Shochet et al., 2001; Stice et al., 2011b; Wilksch et al., 2008) even though the key research interest of the study concerned prevention effects. Given the low numbers of participants who were categorised as ‘recovered’, ‘improved’ and ‘deteriorated’, the z-score test for two population proportions was used to see whether groups differed significantly in prevention and treatment effects (Shochet et al., 2001; Stice et al., 2011b; Wilksch et al., 2008).
Consistent with the definition of prevention effects, the analysis focused on cases that “deteriorated” in each group across time, so as to determine whether the control groups demonstrated increased symptomatology and/or diagnosis compared to the CBT-P group which has an absence of an increase in symptoms over time (Gillham et al., 2000). Similarly, when examining treatment effects, the analysis focused on cases that “recovered” or “improved” in each group across time, so as to determine whether the CBT-P group showed greater improvements in symptomatology or diagnoses in comparison to controls over time (Gillham et al., 2000).
To measure clinically significant prevention effects, a two-tailed test was conducted. To minimise the number of tests conducted, and therefore type I error, analyses were first conducted on groups collapsed across time (i.e., combined across pre-intervention, post-intervention, 3-month follow-up, and 6-month follow-up). If results yielded non-significant p values, it was assumed that the smaller n differences across groups at each time point would also be non- significant. To further reduce type I error, if the z-test results collapsed across time yielded significant p values, analyses were first conducted on groups with the biggest difference in n in the ‘deteriorated’ categories at each time point. If results yielded non-significant p values, it was assumed that those with smaller n differences at each time point would also be non-significant. The same analysis was repeated for clinically significant treatment effects, but analysing the cases who ‘recovered’ or ‘improved’ in each group over time.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/09/2014
Actual
9/09/2014
Date of last participant enrolment
Anticipated
31/01/2016
Actual
31/01/2016
Date of last data collection
Anticipated
31/03/2017
Actual
31/07/2016
Sample size
Target
136
Accrual to date
Final
94
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 290649 0
University
Name [1] 290649 0
Curtin University
Country [1] 290649 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country
Australia
Secondary sponsor category [1] 289340 0
None
Name [1] 289340 0
Address [1] 289340 0
Country [1] 289340 0
Other collaborator category [1] 278304 0
Individual
Name [1] 278304 0
Dr Sarah Egan
Address [1] 278304 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country [1] 278304 0
Australia
Other collaborator category [2] 278305 0
Individual
Name [2] 278305 0
Dr Rebecca Anderson
Address [2] 278305 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country [2] 278305 0
Australia
Other collaborator category [3] 278307 0
Individual
Name [3] 278307 0
A/P Hunna Watson
Address [3] 278307 0
Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. Chapel Hill, NC 27514, USA
Country [3] 278307 0
United States of America
Other collaborator category [4] 278308 0
Individual
Name [4] 278308 0
Dr Tracey Wade
Address [4] 278308 0
School of Psychology
Room 330, Social Sciences North Car park 5
Flinders University
BEDFORD PARK SA 5042
Country [4] 278308 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292279 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 292279 0
Ethics committee country [1] 292279 0
Australia
Date submitted for ethics approval [1] 292279 0
30/09/2013
Approval date [1] 292279 0
26/11/2013
Ethics approval number [1] 292279 0
HR187/2013

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 287 287 0 0
/AnzctrAttachments/367848-Ethics approval official doc.pdf

Contacts
Principal investigator
Name 54450 0
Dr Rebecca Anderson
Address 54450 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 54450 0
Australia
Phone 54450 0
+61 8 9266 3012
Fax 54450 0
NA
Email 54450 0
[email protected]
Contact person for public queries
Name 54451 0
Rebecca Anderson
Address 54451 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 54451 0
Australia
Phone 54451 0
+61 8 9266 3012
Fax 54451 0
NA
Email 54451 0
[email protected]
Contact person for scientific queries
Name 54452 0
Rebecca Anderson
Address 54452 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 54452 0
Australia
Phone 54452 0
+61 8 9266 3012
Fax 54452 0
NA
Email 54452 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



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