Exploration of Acceptability of Alcohol Interventions

May 5, 2026 updated by: East Lancashire Hospitals NHS Trust

A Mixed-methods Study Exploring the Acceptability of Psychosocial Interventions and Social Determinants of Engagement With an NHS-led Alcohol Care Service.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The study will initially consists of a qualitative element assessing the acceptability of psychosocial interventions from the ITEP Manual, delivered by clinical staff, utilising a tailored version of the evidence-based, generic theoretical framework of acceptability questionnaire (Sekhon et al., 2022). This meets the ontological epistemology of a qualitative approach, based upon by its' focus on elicitation of subjective experience, perceptions and effort, in relation to the acceptability of delivering psychosocial interventions (Tombs and Strange, 2024). Assessing this is of particularly importance, as whilst the ITEP Manual has a strong evidence base for successful behaviour change, measures of acceptability regarding delivery are less well evidenced and have been postulated to influence clinicians' readiness to initiate behaviour change conversations, prospectively affecting patient outcomes (Bull et al., 2021).

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. Measures of interest will be based on existing, routinely captured data, including alcohol consumption (Audit-C/ AUDIT scores), and demographic variables of age, gender and socioeconomic status. Engagement can be defined in this case, as patient contact with the service, which might lead to referral to treatment and onward referral (although these latter variables are outside the scope of the current study). The social determinants of health are known to contribute to poorer outcomes, hence identification of those not engaging with such services, offers new opportunities to improve population health (Fraser et al., 2022; Hiam, 2025). Indeed, this philosophy aligns with the NHS 10-year plan which acknowledges the intolerable and detrimental health outcomes of polarised groups in UK society, with clear objectives set out to tackle inequalities in both access and outcomes (NHS, 2025).

It is anticipated that this study will contribute to our understanding of the importance of measuring the acceptability of delivering health behaviour interventions, amongst NHS clinical staff, delivering evidence-based psychosocial interventions. It is also anticipated the study will distinguish which social determinants of health, correlate to engagement with an NHS-based alcohol care service. It offers new opportunities to reflect on, and review current strategies for delivering on objectives, around ameliorating social inequalities within socially deprived areas (NHS, 2025). It may also highlight a need for more research to evaluate prospective improvement opportunities to reduce health inequalities, for those patient groups who are not engaging with such services.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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).

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptability of delivering psychosocial interventions & social determinants of access to an NHS-led Alcohol-Care service.
Time Frame: Anticipated to be no longer than 3 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
East Lancashire Hospitals NHS Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher Gray, Chief Investigator, East Lancashire NHS-Health Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DEV116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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