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Not yet recruitingNCT07580378Updated May 12, 2026

Exploration of Acceptability of Alcohol Interventions

An observational study in Alcohol Misuse, Alcohol Use Disorder and Behaviour Change, sponsored by East Lancashire Hospitals NHS Trust. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 67 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by East Lancashire Hospitals NHS Trust · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
2,000
Ages
18 Years to 67 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Alcohol Misuse
  • Alcohol Use Disorder
  • Behaviour Change
  • Health Behaviour
  • Brief Intervention
  • Outcome Assessment
  • Social Determinants of Health
  • Psychosocial Intervention
  • Socioeconomic Factors
  • Primary Healthcare
  • Primary Heath Care
  • Problem Behavior
03

In context

Alcoholism

1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 159 across 183 observational studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

East Lancashire Hospitals NHS Trust is the lead sponsor of 12 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 67 Years
Sexes eligible
All
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
2,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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).

06

What researchers measure

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.

    Time frame: Anticipated to be no longer than 3 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2026; primary completion for Jun 2026, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
May 5, 2026
First posted
May 12, 2026
StartEst.
May 1, 2026
Primary completionEst.
Jun 1, 2026
CompletionEst.
Jun 10, 2026
Last update
May 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07580378
Lead sponsor
East Lancashire Hospitals NHS Trust
Responsible party
Sponsor
First posted
May 12, 2026
Start date
May 1, 2026 (estimated)
Primary completion
Jun 1, 2026 (estimated)
Completion
Jun 10, 2026 (estimated)
Last update
May 12, 2026

Study contacts

Michelle Stephens, Trust Sponsor
Contact
research.sponsorship@elht.nhs.uk
UK: 07976 152397
Aleksandra (Ola) Metryka, Chief Investigator
Contact
research.sponsorship@elht.nhs.uk
07977267956
Christopher Gray, Chief Investigator
principal investigator · East Lancashire NHS-Health Trust

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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