Trial of a Ward-Based Intervention to Improve Access to P... | NCT03950388

Status Module

Name	Class
Clinical Trials Unit, Manchester	OTHER

Description Module

Brief Summary

The Care Quality Commission (2017) concludes that too often care for people with severe mental health problems on mental health inpatient wards institutionalises people, rather than helping them to have an independent life in the community. There is good evidence that psychological interventions improve patient well-being and independent living, but patients on acute mental health wards often do not have access to evidence-based psychological therapies which are strongly advised by NICE guidance for severe mental health problems (e.g. NICE, 2011). The overall aim of this programme of work is to increase patient access to psychological therapies on acute mental health inpatient wards. Stage one of the programme aimed to identify barriers and facilitators to delivering therapy in these settings through a large qualitative study. The key output of stage one was an intervention protocol that is designed to be delivered on acute wards to increase patient access to psychologically-informed care and therapy. Stage two of the programme aims to test the effects of the intervention on patient wellbeing and serious incidents on the ward which are routinely collated by wards and patient and staff contact is not required (primary outcomes), patient social functioning and symptoms, staff burnout, ward atmosphere from staff and patient perspectives and cost effectiveness of the intervention (secondary outcomes). The study is a single blind, pragmatic, cluster randomised controlled trial and will recruit thirty-four wards across England that will be randomised to receive the new intervention plus treatment as usual, or treatment as usual only. Primary and secondary outcomes will be assessed at baseline and 6-month and 9-month follow-ups, with serious incidents on the ward collected at an additional 3-month follow-up. A process evaluation will be nested within the trial to understand factors that influence the effects of the intervention and implementation in real world settings.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Treatment as Usual	No Intervention
Intervention	Experimental		Behavioral: Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intervention	Behavioral	Wards randomly assigned to receive the intervention will have a Band 8a Psychologist based on the ward for 0.5FTE for 7 months. During this time, all patients will be involved with the proposed stepped model of care intervention at one of three levels. The level the patient receives will be decided by the multidisciplinary ward team. At Step one, all patients will have a psychological formulation developed by the psychologist in conjunction with the patient or members of the ward team. At Step 2, all qualified nurses will be trained and supervised to deliver guided self-help material of psychological interventions targeting key problem areas for patients. At Step 3, patients will be offered up to 16, one-to-one therapy sessions with the psychologist.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient wellbeing	Patient well being using the Warwick-Edinburgh Mental Well-being Questionnaire. WEMWBS: Scale: 1= None of the time, 2 = Rarely, 3 = Some of the time, 4 = Often, 5 = All of the time. Participants are asked to select an option considering the statement over the past 2 weeks. WEMWBS is a 14 item scale with 5 response categories, summed to provide a single score ranging from 14-70. The items are all worded positively and cover both feeling and functioning aspects of mental wellbeing, thereby making the concept more accessible.	Baseline, 6 months and 9 months
Serious incidents on ward	Report taken from each Trust about the number of different serious incidents reported on a ward across a 3 month time period. Serious Incidents: Taken from current reports pulled by each trust to monitor the number of incidents which occur within a ward. Categorised by each Trust using a levelling system of 1-5 with 5 being the most serious level. The incidents are also categorised by event type which varies at each Trust and again is the responsibility of each data entry personnel to assign a category. Data to be taken at baseline for the 3 months prior, at 3 months for the 3 months prior, at 6 months for the 3 months prior and at 9 months for the 3 months prior	Baseline, 3 months, 6 months and 9 months

Secondary Outcomes

Measure	Description	Time Frame
Whether the intervention improves patients' symptoms	Using Brief Symptom Inventory questionnaire. Scale: 0= Not at all; 1 = a little bit, 2 = moderately, 3= quite a bit, 4 = extremely, R= refused Duration: answers based on past 7 days including day of completion Score: The items are all worded positively and cover both feeling and functioning aspects of mental wellbeing.Respondents rank each feeling item (e.g., "your feelings being easily hurt") on a 5-point scale ranging from 0 (not at all) to 4 (extremely). Rankings characterize the intensity of distress during the past seven days. The items comprising each of the 9 primary symptom dimensions are as follows: Somatization: Items 2, 7, 23, 29, 30, 33, and 37 Obsession-Compulsion: Items 5, 15, 26, 27, 32, and 36 Interpersonal Sensitivity: Items 20, 21, 22, and 42 Depression: Items 9, 16, 17, 18, 35, and 50 Anxiety: Items 1, 12, 19, 38, 45, and 49 Hostility: Items 6, 13, 40, 41, and 46 Phobic Anxiety: Items 8, 28, 31, 43, and 47 Paranoid Ideation: Items

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ward:

1) Generic, working-age, adult acute mental health wards.

Staff (RCT Outcome Measures):

Consent to complete self-report measures.
Based on the ward for at least 75% of their working week.

Patient (RCT Outcome Measures):

Capacity to consent to complete the self-report measures
Sufficient levels of concentration to complete the required battery of self-report measures with breaks if needed. This will be determined by the researcher when meeting the participant and in collaboration with the clinical team.
Sufficient English language proficiency to take part in qualitative interviews or agreement to the use of an interpreter. This will be determined by the researcher when meeting the participant and in collaboration with the clinical team.

Staff (Semi-structured interviews):

Consent to have interviews digitally audio recorded.
Direct experience of working with patients with severe mental health problems on an acute inpatient ward that has taken part in the RCT.

Patients (Semi-structured interviews):

Capacity to provide informed consent for interviews.
Consent to have interviews recorded.
At least one week's experience of being an in-patient on an acute in-patient ward that has taken part in the RCT.
Sufficient English language proficiency to take part in qualitative interviews or agreement to the use of an interpreter.

Exclusion Criteria:

Ward:

Wards that have a specialist function, such as older people, intensive care or rehabilitation.
Wards that already have more than 1 session of dedicated psychological therapy input per week. This is because we need to ensure treatment as usual does not include significant elements of the intervention we are aiming to test.

Staff (RCT Outcome Measures):

Non-permanent staff, such as bank or agency workers.
Staff who are planning to leave the ward before the intervention period starts.

Patient (RCT Outcome Measures):

Patients whose discharge is planned for before the start of the intervention period.
Unable to complete self-report measures due to difficulties with concentration or high levels of distress. This will be determined by the researcher when meeting the participant and in collaboration with the clinical team.
Unable or unwilling to provide informed consent.

Staff (Semi-structured interviews):

Non-permanent staff, such as bank or agency workers.
Working on the ward for less than 2 weeks at the time of the interview.
Unwilling to consent to having interviews audio recorded.

Patient (Semi-structured interviews):

Less than one week's experience of in-patient care at the time of the interview.
Unable or unwilling to provide informed consent for interviews.
Unable or unwilling to have interviews audio recorded.
Insufficient English language proficiency to take part in the interview and does not consent to the use of an interpreter.
Insufficient English language proficiency to complete the self-report measures and does not consent to the use of an interpreter.

PubMed Identifier	Type	Citation	Retractions
40155872	Derived	Johnston I, Edge D, Wilson P, Beinaraviciute A, Bucci S, Drake R, Gilworth G, Haddock G, Handerer F, Kaur S, Lovell K, Morley H, Price O, Samji M, Berry K. Increasing access to psychological therapy on acute mental health wards: staff and patient experiences of a stepped psychological intervention. BMC Psychiatry. 2025 Mar 28;25(1):300. doi: 10.1186/s12888-025-06721-7.
35114980

ID	Term
D010549	Personal Satisfaction
D001519	Behavior