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Trial registered on ANZCTR


Registration number
ACTRN12615001323516
Ethics application status
Approved
Date submitted
22/09/2015
Date registered
2/12/2015
Date last updated
26/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Schema Therapy for Eating Disorders
Scientific title
Effect of Schema Therapy on Eating Disorder diagnosis in females with disordered eating
Secondary ID [1] 287399 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
STED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating Disorders 296105 0
Condition category
Condition code
Mental Health 296359 296359 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Schema is an integrative approach to treatment that combines the best aspects of cognitive behavioral, experiential, interpersonal and psychoanalytic therapies into one unified model. The schemas that are targeted in treatment are enduring and self-defeating patterns that typically begin early in life. These patterns consist of negative/ dysfunctional thoughts and feelings, have been repeated and elaborated upon, and pose obstacles for accomplishing one's goals and getting one's needs met. Although schemas are usually developed early in life (during childhood or adolescence), they can also form later, in adulthood. These schemas are perpetuated behaviorally through the coping styles of schema maintenance, schema avoidance, and schema compensation. The Schema-Focused model of treatment is designed to help the person to break these negative patterns of thinking, feeling and behaving, which are often very tenacious, and to develop healthier alternatives to replace them. Schema therapy is gaining widespread acceptability (e.g. it is offered by many private and public mental health hospitals in Australia), and it is becoming an increasingly popular psychological model for working with individuals who have a variety of mental and personality difficulties. This approach has been applied, in both individual and group forms, to a wide variety of clinical disorders, including, borderline personality disorder, chronic depression, and substance abuse (Masley, et al., 2012). A recent stringent systematic review found medium to large effect sizes for schema therapy in the treatment of most conditions (Masley, et al., 2012). The aim of this study is to evaluate the efficacy of group schema therapy for patients with eating disorders. An initial pilot in Scotland was found to be effective with this population in a previous study (Simpson, et al. 2010).

Patients will be asked to attend a one hour screening session with a provisionally or fully registered psychologist (supervised by Dr Smith) to ensure suitability for this type of therapy, before being invited to participate in the group. If they agree to participate in the group, they will then undergo a 2 hour assessment where they will complete a number of standard questionnaires and an assessment. They will then commence the therapy which consists of 25 weekly group sessions lasting for 1.5 hours. Eight to ten patients will be in each group. Each session will be facilitated by 1 to 2 therapists. At least one therapist will be a registered psychologist. Group attendance will be taken weekly to monitor adherence to the intervention.
Intervention code [1] 292753 0
Treatment: Other
Intervention code [2] 293024 0
Behaviour
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296010 0
Eating disorder symptom severity is the primary outcome. This will be measured using the Eating Disorder Examination - Questionnaire (EDE-Q) and will be numerical.
Timepoint [1] 296010 0
Assessments will be conducted at pre- and post-intervention (at 25 weeks). Follow up timepoints will be 6 months and 1-year post-intervention.
Primary outcome [2] 296450 0
The second primary research outcome will be qualification for diagnosis of eating disorder. This will be measured using the Eating Disorder Examination. The outcome of qualification for diagnosis will be dichotomous (Yes/No)
Timepoint [2] 296450 0
.Assessments will be conducted at pre- and post-intervention (at 25 weeks). Follow up timepoints will be 6 months and 1-year post-intervention.
Secondary outcome [1] 317226 0
Cognitive Schemas will be measured using the Young Schema Questionnaire (short form)
Timepoint [1] 317226 0
Assessments will be conducted at pre- and post-intervention (at 25 weeks). Follow up timepoints will be 6 months and 1-year post-intervention.
Secondary outcome [2] 318130 0
Self-Objectification will be measured using the Internalisation of Sociocultural Standards of Beauty (8 items)
Timepoint [2] 318130 0
Assessments will be conducted at pre- and post-intervention (at 25 weeks). Follow up timepoints will be 6 months and 1-year post-intervention.
Secondary outcome [3] 318131 0
General Quality of Life will be measured using the WHO-QOL Scale
Timepoint [3] 318131 0
Assessments will be conducted at pre- and post-intervention (at 25 weeks). Follow up timepoints will be 6 months and 1-year post-intervention.
Secondary outcome [4] 318132 0
Self Compassion will be measured using the Self Compassion Scale
Timepoint [4] 318132 0
Assessments will be conducted at pre- and post-intervention (at 25 weeks). Follow up timepoints will be 6 months and 1-year post-intervention.
Secondary outcome [5] 318133 0
Personality Disorder features will be measured using The Borderline Symptoms Checklist-23 (BSL023) and The Millon Clinical Multiaxial Inventory (MCMI-III)
Timepoint [5] 318133 0
Assessments will be conducted at pre- and post-intervention (at 25 weeks). Follow up timepoints will be 6 months and 1-year post-intervention.
Secondary outcome [6] 318473 0
Schema Mode presentations will be neasured using the Schema Mode Inventory
Timepoint [6] 318473 0
Assessments will be conducted at pre- and post-intervention (at 25 weeks). Follow up timepoints will be 6 months and 1-year post-intervention.
Secondary outcome [7] 318474 0
CORE-OM Outcome Measure Rating Scales of participants' own specific eating behaviours (problem areas)
Timepoint [7] 318474 0
Weekly (during treatment group)
Secondary outcome [8] 318475 0
Abbreviated EDE-Q measure of symptoms (drive for thinness, restriction etc)
Timepoint [8] 318475 0
Weekly (during treatment group)

Eligibility
Key inclusion criteria
Participants must be 18 years of age or older and must have some form of disordered eating (e.g. anorexia nervosa, bulimia nervosa, binge-eating disorder, eating disorder not otherwise specified).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria include factors that would prevent participants from actively engaging in therapy and that would necessitate alternative treatment or admission to inpatient care (for instance, active suicidality).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 292060 0
University
Name [1] 292060 0
UWS start-up funds
Country [1] 292060 0
Australia
Funding source category [2] 292061 0
University
Name [2] 292061 0
UWS Women's Fellowship
Country [2] 292061 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Bankstown Campus
Bullecourt Avenue
Milperra NSW 2214
Country
Australia
Secondary sponsor category [1] 290736 0
University
Name [1] 290736 0
University of South Australia
Address [1] 290736 0
101 Currie Street
Adelaide SA 5001
Country [1] 290736 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293545 0
Human Ethics: Western Sydney University
Ethics committee address [1] 293545 0
Ethics committee country [1] 293545 0
Australia
Date submitted for ethics approval [1] 293545 0
Approval date [1] 293545 0
20/07/2015
Ethics approval number [1] 293545 0
H11151

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60022 0
Dr Evelyn Smith
Address 60022 0
Western Sydney University
Locked Bag 1797
Penrith
NSW 2751
Country 60022 0
Australia
Phone 60022 0
+61 2 9772 6707
Fax 60022 0
Email 60022 0
Evelyn.Smith@westernsydney.edu.au
Contact person for public queries
Name 60023 0
Evelyn Smith
Address 60023 0
Western Sydney University
Locked Bag 1797
Penrith
NSW 2751
Country 60023 0
Australia
Phone 60023 0
+61 2 9772 6707
Fax 60023 0
Email 60023 0
Evelyn.Smith@westernsydney.edu.au
Contact person for scientific queries
Name 60024 0
Evelyn Smith
Address 60024 0
Western Sydney University
Locked Bag 1797
Penrith
NSW 2751
Country 60024 0
Australia
Phone 60024 0
+61 2 9772 6707
Fax 60024 0
Email 60024 0
Evelyn.Smith@westernsydney.edu.au

No information has been provided regarding IPD availability


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.