NCT07580378

Brief Summary

This is a mixed-methods study consisting of a qualitative assessment the acceptability of psychosocial interventions, delivered by clinical staff. The study will also investigate the correlation between demographic variables and engagement with a North West England, NHS-led, alcohol care service, amongst the patient population.

Trial Health

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Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
0mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Progress56%
May 2026Jun 2026

Study Start

First participant enrolled

May 1, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2026

Last Updated

May 12, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

May 5, 2026

Last Update Submit

May 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Acceptability of delivering psychosocial interventions & social determinants of access to an NHS-led Alcohol-Care service.

    Directed Content Analysis (DCA) will be used to analyse data from the outputs of the TFA-based questionnaire regarding the acceptability of interventions (Hsieh et al., 2005; Sekhon., et al, 2022). Descriptive statistics will be used to describe the current patient contact data from patients who engaged with the service during September 2023 and December 2024.

    Anticipated to be no longer than 3 months

Study Arms (1)

Clinical ataff who delivered psychosocial interventions and staff who engaged with the service

The participants for part 1 will be identified by the former service lead, who still works in the Trust. A list of all the clinical staff who worked in the alcohol care service will be provided to the Chief Investigator, in order to facilitate contact, with prospective participants. This will be done via email correspondence on Trust computers, to work-based email addresses, to ensure that all correspondence within the study, is protected by Trust IT security. Part 2: The data pertaining to the patient contacts between September 2023 and December 2024, will be screened by the NHS England MESH team to determine if any patients have opted out of sharing their data for research purposes. Once confirmed, the residual data between September 2023 and December 2024 will then be reviewed for inclusion in the data analysis. That is, given that data is captured from a single-time point, for each data set (i.e. there is no intervention follow-up data to compare against).

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Part 1: The participants for part 1 will be identified by the former service lead, who still works in the Trust. A list of all the clinical staff who worked in the alcohol care service will be provided to the Chief Investigator, in order to facilitate contact, with prospective participants. Part 2: Patients who had contact with the East Lancashire NHS-Health Trust alcohol-care service, between September 2023 and December 2024 (but who have not opted-out of their data being utilised for research purposes).

You may qualify if:

  • Clinical staff who worked in the ELHT alcohol care service, and received training in the delivery of psychosocial interventions using the ITEP Manual, and who are still employed by ELHT in other roles (following de-commissioning of the alcohol care service).
  • Patient data under part 2 of the study, who have not opted to have their data removed, in accordance with the NHS MESH, opt out scheme.

You may not qualify if:

  • Clinical staff who worked in the ELHT alcohol care service, but who no longer work for the trust, or are retired.
  • Clinical staff who did not receive training in the delivery of psychosocial interventions.
  • Any patient data under part 2 of the study, who have opted to have their data removed for use, under the NHS MESH protocols.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burnley General Teaching Hospital

Burnley, Lancashire, BB102pq, United Kingdom

Location

MeSH Terms

Conditions

AlcoholismProblem Behavior

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavioral SymptomsBehaviorChild Behavior

Study Officials

  • Christopher Gray, Chief Investigator

    East Lancashire NHS-Health Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Stephens, Trust Sponsor

CONTACT

Aleksandra (Ola) Metryka, Chief Investigator

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 12, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 10, 2026

Last Updated

May 12, 2026

Record last verified: 2026-04

Locations