NCT06905184

Brief Summary

Design A quasi-experimental mixed methods design research study will be conducted within: Pippin Ward, a 10 bed Female PICU within Cygnet Appletree (data collected January - June 2022). Haywood Ward, a 16 Male Acute within Cygnet Kewstoke. Nash Ward, a 12 bed Male PICU within Cygnet Kewstoke. Sandford Ward, a 16 bed Female Acute within Cygnet Kewstoke. Juniper Ward, a 17 bed Male Acute within Cygnet Churchill. Castle Ward, a 12 bed Female PICU within Cygnet Godden Green. Oakwood ward, a 15 bed Female Acute within Cygnet Godden Green. The study will measure the change in provision of meaningful activity types, and frequency of participation within meaningful activities, as a result of the intervention, 'Activity PRN', on participating wards within Cygnet Healthcare Ltd. Activity PRN, is an approach that uses occupational therapy approaches to facilitate meaningful activities as and when required. A 'prn activity' is any personally meaningful activity which can be facilitated as and when required, and is not a timetabled activity or session. To show the effect of the intervention, a three month control period, pre-intervention, will measure the number of meaningful activity types provided, facilitated on an 'ad-hoc' basis, and participation frequency. A two week period will follow, in which ward based staff will receive training to implement Activity PRN. A further three month intervention period will measure the number of prn activity types provided, and the participation frequency of prn activities, as a result of delivering Activity PRN. It is hoped that about 60 patients will consent to receive the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

March 25, 2025

Last Update Submit

March 31, 2025

Conditions

Keywords

Activity PRNOccupational TherapyCygnet HealthcareMental HealthPICUAcute

Outcome Measures

Primary Outcomes (2)

  • PRN Activities

    An increase in provision of 'as when required' (prn) activities across all services monitored.

    6 months

  • Participation rate

    An increase in participation frequency of 'prn activities', compared to 'ad hoc' meaningful activities pre-intervention.

    6 months

Study Arms (1)

Patient Group

EXPERIMENTAL

Individuals aged 18-65 years, admitted to a Psychiatric Intensive Care Unit or Acute Mental Health Unit, who receive the intervention Activity PRN.

Behavioral: Activity PRN

Interventions

Activity PRNBEHAVIORAL

An Activity PRN plan will be delivered to consenting patients, as described above. The intervention will be communicated to them as a new approach that 'supports the individual to engage in personalised meaningful activities, which they can engage in as and when required'. Activity Resources are organised within a suitable, accessible location according with the patient's risk management and support plan. Dependent on the plan, resources may be kept on their person, in their bedroom, in a communal area, or in a locked or unlocked accessible cupboard. Ward staff will facilitate prn activities on an 'as and when required' basis. This can occur when: 1) a patient requests an activity from their card, 2) the patient appears disengaged, or 3) staff deem that the patient may benefit from participation in an activity for the purpose of engagement or distraction.

Patient Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female 18-65 Any ethnicity Any socio economic grouping Must be admitted to hospital for any primary diagnosis of a mental health condition Location as per units referred to in the study setting

You may not qualify if:

  • Excluded participants are those who do not give informed consent, or cannot give informed consent by review of the Multi-Disciplinary Team within participating wards.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cygnet Maidstone Hospital

Maidstone, Kent, ME14 5FY, United Kingdom

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Treatment: One or more interventions are being evaluated for treating a disease, syndrome, or condition.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Occupational Therapy

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 1, 2025

Study Start

July 1, 2024

Primary Completion

February 19, 2025

Study Completion

March 25, 2025

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations