NCT04072510

Brief 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 disorders; 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2020

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

1.5 years

First QC Date

August 21, 2019

Last Update Submit

August 27, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rosenberg Self-esteem Scale: assessing change in self-esteem

    A validated self-report measure assessing change in self-esteem. The measure consists of 10 questions.

    Assessed at baseline, 6 weeks and 10 weeks.

Secondary Outcomes (1)

  • Eating Disorder Examination Questionnaire: assessing change in eating disorder psychopathology

    Assessed at baseline, 6 weeks and 10 weeks.

Study Arms (2)

Case: Self-esteem group + Treatment as Usual

EXPERIMENTAL

Self-esteem group is based on a cognitive behavioral model of low self-esteem addressing thoughts, feelings and behaviour. The self-esteem group is designed to be administered in 6 weekly sessions. Treatment as usual refers to the standard inpatient treatment programme at Newbridge House which includes: individual therapy, occupational therapy, drama therapy, family therapy, dietetic support, nursing support, yoga and medication prescribed by a consultant psychiatrist.Treatment as usual occurred alongside the self-esteem group.

Behavioral: Self-esteem group

Control: Treatment as Usual Only

ACTIVE COMPARATOR

Treatment as usual refers to the standard inpatient treatment programme at Newbridge House which includes: individual therapy, occupational therapy, drama therapy, family therapy, dietetic support, nursing support, yoga and medication prescribed by a consultant psychiatrist.

Behavioral: Treatment as Usual

Interventions

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

Case: Self-esteem group + Treatment as Usual

Treatment as usual refers to the standard inpatient treatment programme at Newbridge House which includes: individual therapy, occupational therapy, drama therapy, family therapy, dietetic support, nursing support, yoga and medication prescribed by a consultant psychiatrist.

Control: Treatment as Usual Only

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Inpatients at Newbridge House
  • Aged 11-18
  • Primary diagnosis of any form of eating disorder

You may not qualify if:

  • Previously received self-esteem group at Newbridge House
  • Aged under 10 years
  • Moderate and severe learning disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Newbridge House

Sutton Coldfield, B74 3NE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Feeding and Eating Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Psychologist

Study Record Dates

First Submitted

August 21, 2019

First Posted

August 28, 2019

Study Start

October 22, 2018

Primary Completion

April 22, 2020

Study Completion

April 22, 2020

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations