Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04072510 |
| Other study ID # |
Newbridge House |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 22, 2018 |
| Est. completion date |
April 22, 2020 |
Study information
| Verified date |
August 2019 |
| Source |
Newbridge House |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Self-esteem group is a novel, manualised group programme designed for adolescent inpatients
with eating disorders.
Research questions:
Does the self-esteem group improve self-esteem in adolescent inpatients with eating
disorders? Are any changes in self-esteem maintained at 4 week follow-up after the group?
Does eating disorder psychopathology improve more during admission for those who complete the
self-esteem group compared to those who do not complete the group?
Background:
Low self-esteem has been established as a strong predictor of onset, maintenance and relapse
in eating disorders. For patients with low self-esteem, change can be particularly difficult
to achieve. The intensity of their low self-esteem leads them to strive to control their
eating, weight and shape to gain a sense of self-worth and the pervasive negative view of
themselves results in them seeing little or no prospect of recovery. This suggests treatment
of low self-esteem is clinically and financially important. Studies have shown cognitive
behavioural based group therapies improve self esteem in adults with eating disordersÍž
however research including adolescents is limited. This research will contribute to the
evidence base for self-esteem interventions in adolescents and inform the effectiveness of a
new treatment. The research will be funded by Newbridge House, an inpatient unit for children
and adolescents with eating disorders.
Design:
Inpatients at Newbridge House aged 11 - 18, fulfilling DSM-V criteria for an eating disorder
will be recruited.Participants will be randomly allocated to a case or control group. Cases
will receive the 6 week self-esteem group in addition to treatment as usual (TAU) and will be
compared with controls who receive TAU. Both groups will complete a questionnaire pre-group,
post-group and 4 weeks post-group. Admission and discharge questionnaires routinely collected
will be examined to assess change in eating disorder psychopathology.
Description:
Low self-esteem has been established as a strong predictor of onset, maintenance and relapse
in eating disorders. For patients with low self-esteem, change can be particularly difficult
to achieve, with the potential for prolonged admissions and increased burden of illness to
the individual and their family or carers. Significant low self-esteem can contribute to
increased striving to control eating, weight and shape to gain a sense of self-worth.
Furthermore, it can serve to maintain pervasive negative self- regard and a sense of little
or no prospect of recovery. This suggests treatment of low self-esteem is both clinically and
financially important. Studies have shown that cognitive behavioural based group therapies
can improve self-esteem in adults with eating disorders; however research including
adolescents is limited.
This study will contribute to the evidence base for self-esteem interventions in adolescents
through evaluating the effectiveness of a new treatment. The self-esteem group intervention
evaluated in this study is a novel, manualised group therapy programme designed specifically
for adolescent inpatients with eating disorders.
The research will be funded and supported by Newbridge House, inpatient unit for children and
adolescents with eating disorders.
Principal Research Question:
Does delivery of a manualised self-esteem group intervention improve self-esteem in
adolescent inpatients with eating disorders?
Secondary Research Question:
Are any changes in self-esteem maintained at 4 week follow-up after the group? Does eating
disorder psychopathology improve more during the 10 week period for those who complete the
self-esteem group compared to those who do not complete the group?
The study aims to generate hypotheses about whether the group intervention is effective in
improving self-esteem and/or eating disorder psychopathology.
Research design and methods
Participants:
Participants will be inpatients aged 11-18 who fulfil DSM-V criteria for an eating disorder,
meet the framework of inclusion and exclusion criteria and are receiving treatment at
Newbridge House child and adolescent inpatient eating disorder unit. A convenience sampling
method will be used and participants will be randomly allocated using an Excel formula to
either a 'case' group to complete TAU plus self-esteem group or a 'control' group to only
complete TAU.
A control group (TAU) was included in order to compare outcomes of those who complete PBI
with outcomes of those who do not. This is because the principal aim of the study is to
generate evidence of the potential effectiveness of this novel treatment. This is especially
necessary given that the research site is an inpatient unit and all participants will be
receiving other therapies alongside the treatment being tested.
Forty participants will be recruited in total (twenty in each group). As this is a pilot
study no power calculation could be conducted and this sample size was agreed as sufficient
to generate data to inform a power calculation for future research. Participants will be
identifiable by a unique code created using the letters 'TAU+SE' or 'TAU' followed by a
number relating to the order in which they were recruited.
Potential participants will be approached by an Assistant Psychologist when they reach 85% of
their healthy weight to introduce the research and seek consent for participation in the
study. For patients under the age of 16, informed parental consent and patient assent will be
sought. For patients over 16 only informed patient consent will be sought. Patients under 16
will not take part in the study unless both parental consent and patient assent has been
received. Patients and parents will be given up to 7 days to decide whether to give consent
to participate in the study. Those who consent will then be allocated to the treatment or
control group using the excel formula. Once 4 people have been allocated to the treatment
group they will begin the self-esteem group.
Design:
To gather evidence for the research questions, a between subjects design (Self-esteem vs no
self-esteem) will be used with treatment as the independent variable. The case group will
receive TAU as well as the self-esteem group and the control group will just receive TAU. The
outcomes from self-report questionnaires completed post-group, 4 week follow-up and at
discharge will be compared between the case and control groups.
The dependent variables are self-esteem and eating disorder psychopathology as measured by
self-report questionnaires. This experimental design has been chosen as it allows for the
comparison of self-esteem vs no self-esteem. The choice of this design was influenced by a
desire to gather evidence to generate hypotheses about this novel treatment and to inform a
full scale study to test the effectiveness of this treatment for adolescents with eating
disorders.
Timetable All stages will take place on site at Newbridge House only.
STAGE 1 (Recruitment) Patients will be approached to take part in the study when they reach
85% of their healthy weight. An assistant psychologist will meet with patients meeting the
framework of inclusion and exclusion criteria to read through the research information sheet
and request informed written consent. For patients under 16 written, informed consent and
patient assent will be sought and parents will be given an information sheet and consent form
prior to commencement of the study. For those over the age of 16 written informed consent
will be sought only from patients. Patients and parents will be given 7 days to consider
their decision to consent to participate in the research. Patients will not be recruited as a
participant unless consent has been obtained from the person with parental responsibility and
assent has been obtained from the patient, if under 16. If both are not obtained, the patient
will not be recruited for the study.
Patients for whom we receive consent will then be randomly allocated to either the case or
control group using an Excel formula. Patients who do not consent, or for whom parental
consent is not received, will receive TAU which will be identical to that delivered to
controls.
STAGE 2 (Week 1) All participants will be asked to complete a set of self-report
questionnaires in week 1 (baseline) when they start the group for case participants and when
they have consented for the research for control participants. For participants in the case
group, the self-esteem group will then commence and take place alongside TAU. For
participants in the control group, TAU will continue as normal.
STAGE 3 (Week 6) Stage 3 will take place 6 weeks after completion of baseline measures. All
participants will complete a second set of measures.
STAGE 4 (Week 10) Stage 4 will take place 10 weeks after completion of baseline measures. All
participants will complete a third set of measures.
STAGE 4 (Date analysis) Stage 5 will take place after all 40 participants have been recruited
and completed the study, thus ending the data collection stage. Assistant psychologists on
site will then input the raw data from completed outcome measures onto an SPSS spreadsheet.
Data will then be analysed and interpreted by a qualified statistician.
STAGE 6 (Report write up) Stage 6 will take place after completion of data analysis. The
final report will then be written and submitted for publication by those involved in the
research.
Statistical Analysis As a pilot study, the primary aim of the data analysis phase will not be
to definitively test whether the self-esteem group is effective or not but to generate
evidence of its potential effectiveness if progressed onto a full trial.
In order to do this we will use analysis of covariance (ANCOVA) to estimate the difference in
self-reported self-esteem at week 6 and week 10, between conditions, controlling for baseline
self-reported self-esteem as a covariate. The difference in self-reported self-esteem scores
will be reported (adjusted for baseline levels) within 95% confidence intervals to indicate
the potential effectiveness of the self-esteem intervention in comparison to TAU. Primary
analysis will be on an intention-to-treat basis. The assumptions or normality and homogeneity
of variance will be assessed. Normality assumes that the scores are normally distributed
(bell-shaped) and will be assessed using the One-sample Kolmogorov-Smirnov test. Homogeneity
of variance assumes that both groups have equal error variances and will be assessed using
Levene's Test for the equality of error variances. The relationship between the covariate and
the dependent variable should be linear and will be assessed with a scatterplot.
A secondary analysis will explore the difference in self-reported eating disorder
psychopathology at discharge between the case and control group.
Drop-out rates between the self-esteem and TAU groups will also be assessed to explore the
acceptability of treatment condition. We plan to conduct these analyses using the latest
version of IBM SPSS statistics.
Treatment protocol
The intervention will comprise of 6 sessions of group self-esteem therapy which uses a
cognitive behavioural approach. The therapy has been manualised into a 76 page treatment
protocol and will be administered by Assistant Psychologists employed at Newbridge House
receiving weekly supervision from a Clinical Psychologist. The self-esteem group is based on
Melanie Fennel's cognitive behavioural model of low self-esteem addressing thoughts, feeling
and behaviours. The group aims to improve self-esteem and build positivity.
The sessions are structured and laid out in the following overview:
Week 1, Session 1: What is self-esteem and an introduction to CBT Week 2, Session 2: How
might low self-esteem develop? Week 3, Session 3: Negative automatic thoughts Week 4, Session
4: Challenging negative automatic thoughts Week 5, Session 5: Creating new coping strategies
Week 6, Session 6: Building positivity
