NCT06961032

Brief Summary

The ALLIANCE study aims to understand and improve treatment relationships between staff and service users in inpatient eating disorder settings. It is NIHR funded and consists of 3 work packages (WP): WP1: Develop Programme Theory using realist literature review to identify how to effectively develop therapeutic alliance in inpatient treatment for Eating Disorders (ED), that maintains safety, whilst leading to improved treatment outcomes. WP1 consists of a literature review, using realist methods. Conducting this review will help us to understand existing evidence relating to treatment relationships in inpatient eating disorder setting. This WP is already underway. WP2: Test, expand and refine the theory via realist interviews with people who have lived experience of inpatient ED treatment and healthcare staff working in inpatient ED settings. Use the Programme Theory to develop actionable practice and policy recommendations to improve treatment outcomes, that can be operationalised (in a future study) into a complex intervention to improve alliance and treatment outcomes for ED. WP3: Codesign an animation (and supporting materials) with people with lived experience, to disseminate and communicate WP2 findings.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

April 29, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

May 7, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

April 29, 2025

Last Update Submit

April 29, 2025

Conditions

Keywords

eating disorderstherapeutic allianceinpatient care

Outcome Measures

Primary Outcomes (1)

  • Qualitative experiences of inpatient eating disorder treatment

    Qualitative semi-structured interviews with ED service users and healthcare professionals abut their experiences and perceptions of inpatient ED treatment and care.

    Within the past 5 years of discharge from inpatient ED services.

Study Arms (2)

Service Users with diagnosis of ED

Adults 18+ who have received a diagnosis of any ED, and have previously been admitted to an inpatient mental health ward for treatment within the last 5 years.

Healthcare Professionals

Healthcare professionals with experience of working in an inpatient eating disorders unit.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults who have a prior diagnosis of ED and who have lived experience of being admitted onto an inpatient ED ward. Participants are identified from community ED teams and advertised through national ED support charities. Healthcare professional participants who have a professional experience of working on inpatient ED wards will be approached through participating NHS sites and national ED charities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Leicestershire Partnership NHS Trust

Leicester, Leicestershire, LE3 8RA, United Kingdom

Location

Newmarket House Clinic

Norwich, Norfolk, NR4 6SY, United Kingdom

Location

Norfolk and Suffolk NHS Foundation Trust

Norwich, Norfolk, NR6 5BE, United Kingdom

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

  • Corinna J Hackmann, PhD, ClinPsyD

    Norfolk and Suffolk NHS Foundation Trust

    PRINCIPAL INVESTIGATOR
  • Susan Holmes, PhD

    University of East Anglia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte J Wheeler, MSc

CONTACT

Lisa M Gruenwald, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 7, 2025

Study Start

May 1, 2025

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

May 7, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Anonymised qualitative data about service experiences and experiences of individual practitioners will not be shared publicly by agreement with ethics board due to sensitive nature of responses.

Locations