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Trial registered on ANZCTR


Registration number
ACTRN12616001625460
Ethics application status
Approved
Date submitted
21/11/2016
Date registered
24/11/2016
Date last updated
29/06/2021
Date data sharing statement initially provided
29/06/2021
Date results provided
29/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the efficacy of a brief psychoeducation and skills-based group intervention for the carers of individuals with eating disorders: A randomised controlled trial
Scientific title
Evaluating the efficacy of a brief psychoeducation and skills-based group intervention for the carers of individuals with eating disorders: A randomised controlled trial
Secondary ID [1] 290585 0
Nil known
Universal Trial Number (UTN)
U1111-1190-1574
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating Disorders 301044 0
Condition category
Condition code
Mental Health 300831 300831 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves attending two 150-minute group sessions at a community mental health clinic (Centre for Clinical Interventions, Perth, Western Australia). Content for both group sessions has been adapted from Skills-based learning for caring for a loved one with an eating disorder: the new Maudsley method (Treasure, Smith, & Crane, 2007). The first session content will involve a summary of psychoeducation information (sent out in an information pack prior to the intervention), focusing on the role of genetics, biological, and neurological factors (e.g. starvation syndrome). Participants will be invited to ask questions and discuss anything they found surprising. The role of environmental factors will also be discussed, and the interpersonal maintenance model of eating disorders will be introduced. Common communication "traps" will be discussed as a group (with participants providing personal examples). Homework between sessions will involve approaching the individual with the eating disorder and setting a time to discuss the eating disorder either one-on-one or with the family. The second session will occur one week later and will also be 150-minutes in duration. The homework task will be reviewed, and participants will be introduced to a number of strategies they can utilise when difficult situations arise in relation to the individual with the eating disorder. Participants will be asked to role play difficult situations and practice using helpful phrases and simple techniques recommended by Treasure and colleagues (2008) in order to diffuse them.

The intervention will be co-facilitated by two therapists. One therapist will be a qualified masters or doctoral level clinical psychologist, and the second therapist will be a qualified masters or doctoral level clinical psychologist or a provisionally registered psychologist (clinical psychologist trainee).

Group facilitators will be guided by a protocol and overheads to standardise delivery. The psychoeducation sessions will be audio-recorded and an independent assessor will complete a standardised form to indicate whether all components were completed for each group session.
Intervention code [1] 296448 0
Behaviour
Comparator / control treatment
Waitlist control group. After waitlisted participants have completed the 1-month follow-up period, they will be invited to attend the next group psychoeducation sessions outside of the trial, which are expected to be within 1-2 months from the follow-up period.
Control group
Active

Outcomes
Primary outcome [1] 300260 0
Changes in caregiver burden as measured by Burden Assessment Scale (BAS) (Platt, 1985).
Timepoint [1] 300260 0
Prior to intervention; immediately following intervention; one-month follow-up.
Secondary outcome [1] 329513 0
Changes in caregiver anxiety levels as measured by the Patient Reported Outcomes Measurement Information System for Anxiety (PROMIS-A) (Cella, Riley, Stone, Rothrock, Reeve, Yount, Anthmann, Dagmar, Bode, Buysse, Choi, Seung, Cook, Devillis, Dewlat, Fries, Gershon, Hahn, Lai, Pilkonis, Revicki, Rose, Weinfurt, & Hays, 2010).
Timepoint [1] 329513 0
Prior to intervention; immediately following intervention; one-month follow-up.
Secondary outcome [2] 329514 0
Changes in levels of caregiver expressed emotion as measured by the Family Questionnaire (FQ) (Wiedemann, Rayki, Feinstein, & Hahlweg, 2002)
Timepoint [2] 329514 0
Prior to intervention; immediately following intervention; one-month follow-up.
Secondary outcome [3] 329515 0
Changes in caregiver accommodating and enabling behaviours as measured by the Accommodating and Enabling Scale for Eating Disorders (AESED) (Hibbs, Rhind, Salerno, Lo Coco, Goddard, Schmidt, Micali, Gowers, Beecham, Macdonald, Todd, Campbell, & Treasure, 2014). The AESED contains 6 subscales, but the whole scale has high internal consistency (alpha = .92, Hibbs et al., 2014) suggesting that a total score is appropriate to calculate, which will be used as the secondary outcome.
Timepoint [3] 329515 0
Prior to intervention; immediately following intervention; one-month follow-up.
Secondary outcome [4] 329516 0
Changes in caregiver interpersonal skills as measured by the Caregiver Skills (CASK) (Hibbs, Rhind, Salerno, Lo Coco, Goddard, Schmidt, Micali, Gowers, Beecham, Macdonald, Todd, Campbell, Treasure, 2015).
Timepoint [4] 329516 0
Prior to intervention; immediately following intervention; one-month follow-up.
Secondary outcome [5] 329517 0
Changes in caregiver coping self-efficacy as measured by the Caregiver Self Efficacy Scale (CSE) which was created with the assistance of staff who specialise in eating disorders at the Centre for Clinical Interventions.
Timepoint [5] 329517 0
Prior to intervention; immediately following intervention; one-month follow-up.
Secondary outcome [6] 329518 0
Changes in caregiver's knowledge of eating disorders as measured by a brief version of the the Carers' Needs Assessment Measure (CaNAM) (Haigh & Treasure, 2003).
Timepoint [6] 329518 0
Prior to intervention; immediately following intervention; one-month follow-up.
Secondary outcome [7] 329519 0
Changes in caregiver levels of depression as measured by the Patient Reported Outcomes Measurement Information System (PROMIS-D) (Cella, Riley, Stone, Rothrock, Reeve, Yount, Anthmann, Dagmar, Bode, Buysse, Choi, Seung, Cook, Devillis, Dewlat, Fries, Gershon, Hahn, Lai, Pilkonis, Revicki, Rose, Weinfurt, & Hays, 2010).
Timepoint [7] 329519 0
Prior to intervention; immediately following intervention; one-month follow-up.
Secondary outcome [8] 329526 0
Changes in carer interpersonal skills as perceived by the individual who has the eating disorder as measured by a version of the CASK that has been modified (with permission of the authors) to be suitable for use with the individual who has the eating disorder.
Timepoint [8] 329526 0
Prior to intervention; immediately following intervention; one-month follow-up.

Eligibility
Key inclusion criteria
1) Carers must be aged over 18 years; 2) able to speak and read English fluently, 3) currently care for someone with diagnosed eating disorder (either as a friend, family member or partner). Participants are also asked to invite the person with the eating disorder to complete a questionnaire on their perspective of their caregiver’s skills before and after the intervention. These participants may be under age 18, but will still receive an information sheet and consent form that will be co-signed by their parent/guardian.
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The carers attending the psychoeducation groups must be adults (18 years or over). As has been standard practice at CCI for several years, no other exclusion criteria will be applied for the carer groups. The individual with the eating disorder must be at least 7 years of age before being invited to provide data about their relationship with the carer at pre, post, and follow-up.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The co-ordinating PI will generate a simple randomisation schedule (1:1) using www.random.org. Participants will be randomised after their initial assessment of eligibility.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Five hypotheses are proposed:
H1: Reduction in carer burden will be greater in the intervention group compared to controls
H2: Intervention will result in positive changes in secondary outcomes of distress, level of expressed emotion, accommodating and enabling behaviours, caregiver interpersonal skills, coping self-efficacy, knowledge of eating disorders.
H3: Changes in carer interpersonal skills will be reported by the individual who has an eating disorder
H4: Changes in level of expressed emotion, accommodating and enabling behaviours, caregiver interpersonal skills, coping self-efficacy, and knowledge of eating disorders will mediate the effect of the intervention on carer burden.
H5: Intervention effects will maintain to one-month follow-up.

Hypotheses 1, 2, 3 and 5 will be tested with a series of Generalised Linear Mixed Models (GLMMs) – one for each outcome measure. For the GLMMs, there is one nominal random effect (participant), one nominal fixed effect of group (intervention, waitlist), and one ordinal fixed effect (time: pre, post, follow-up). H1, H2, H3, and H5 predict a significant Group by Time interaction effect.

The indirect effect hypothesis 4, where changes in carer burden from pre-post intervention are mediated by changes in the mediators, will be tested using path analysis in Mplus (Muthen & Muthen, 1998-2015). Post-scores on carer burden (controlling for pre-scores) will be regressed on the hypothesised post-scores (controlling for pre-scores) on the mediators (self-efficacy, knowledge, perceived burden of care, accommodating and enabling behaviours, level of expressed emotion, and interpersonal caregiver skills), controlling for the pre-scores, which will be regressed on Condition (intervention vs. waitlist). Bootstrapping using 1000 resamples will be used to estimate indirect effects with 90% confidence intervals.

A power analysis using G*Power software was conducted assuming a low to medium effect size (f = .20), an alpha of .05, power of .80, an autocorrelation of .5, and three measurement occasions. This analysis suggested that a minimum of 42 participants were required. Each individual group will have a minimum of six participants and a maximum of 20.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/12/2016
Actual
1/11/2017
Date of last participant enrolment
Anticipated
1/08/2018
Actual
1/06/2018
Date of last data collection
Anticipated
1/10/2018
Actual
18/07/2018
Sample size
Target
42
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 6962 0
Centre for Clinical Interventions - Northbridge
Recruitment postcode(s) [1] 14655 0
6003 - Northbridge

Funding & Sponsors
Funding source category [1] 295018 0
University
Name [1] 295018 0
Curtin University
Country [1] 295018 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley, Western Australia, 6102
Country
Australia
Secondary sponsor category [1] 293836 0
None
Name [1] 293836 0
Address [1] 293836 0
Country [1] 293836 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296372 0
WA Health HREC
Ethics committee address [1] 296372 0
Ethics committee country [1] 296372 0
Australia
Date submitted for ethics approval [1] 296372 0
13/10/2016
Approval date [1] 296372 0
08/11/2016
Ethics approval number [1] 296372 0
19_2016
Ethics committee name [2] 296373 0
Curtin University Human Research Ethics Committee
Ethics committee address [2] 296373 0
Ethics committee country [2] 296373 0
Australia
Date submitted for ethics approval [2] 296373 0
10/11/2016
Approval date [2] 296373 0
11/11/2016
Ethics approval number [2] 296373 0
HRE2016_0452

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1249 1249 0 0
/AnzctrAttachments/371890-Research Protocol.docx (Protocol)
Attachments [2] 1251 1251 0 0
/AnzctrAttachments/371890-Participant Consent Form and Information Sheet.pdf (Participant information/consent)
Attachments [3] 1253 1253 0 0
/AnzctrAttachments/371890-Ethical Approval_21_11.pdf (Ethics approval)
Attachments [4] 1254 1254 0 0
/AnzctrAttachments/371890-Curtin Reciprocal Approved_HRE2016_0452.pdf (Ethics approval)

Contacts
Principal investigator
Name 70618 0
Prof Peter McEvoy
Address 70618 0
School of Psychology and Speech Pathology
Curtin University
Kent Street, Bentley, Western Australia, 6102
Country 70618 0
Australia
Phone 70618 0
+61 08 9266 5110
Fax 70618 0
Email 70618 0
peter.mcevoy@curtin.edu.au
Contact person for public queries
Name 70619 0
Peter McEvoy
Address 70619 0
School of Psychology and Speech Pathology
Curtin University
Kent Street, Bentley, Western Australia, 6102
Country 70619 0
Australia
Phone 70619 0
+61 08 9266 5110
Fax 70619 0
Email 70619 0
peter.mcevoy@curtin.edu.au
Contact person for scientific queries
Name 70620 0
Peter McEvoy
Address 70620 0
School of Psychology and Speech Pathology
Curtin University
Kent Street, Bentley, Western Australia, 6102
Country 70620 0
Australia
Phone 70620 0
+61 08 9266 5110
Fax 70620 0
Email 70620 0
peter.mcevoy@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Explicit consent from participants to share data was not received. Further details about the study protocol, informed consent form, clinical study report (publication), ethical approval will be available from the corresponding author upon request.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.