Mental HealthTULIPSNCT03950388
Trial of a Ward-Based Intervention to Improve Access to Psychologically-Informed Care and Psychological Therapy for Mental Health In-Patients
A study testing Intervention in people with Mental Health, run by University of Manchester at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Mental Health
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 21 Oct 2019to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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):
Show all 17Show fewer
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Leed & York Partnership NHS Foundation Trust
Leeds
Crystal-Bella Romain-Hooper, c.romain-hooper@nhs.net
- Recruiting
Greater Manchester Mental Health NHS Foundation Trust
Manchester, Greater Manchester
Jessica Raphael, jessica.raphael@manchester.ac.uk
About this study
Official title: A Cluster Randomised Controlled Trial of a Ward-Based Intervention to Improve Access to Psychologically-Informed Care and Psychological Therapy for Mental Health In-Patients
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.
- Conditions
- Mental Health
- Being tested
- Intervention
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | No intervention | Not described |
| Intervention | Experimental | Not described Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline, 3 months, 6 months and 9 months
Secondary outcomes (10)
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
Measured: Baseline, 6 months and 9 months
Whether the intervention improves staff perceptions of ward atmosphere.
Using the VOTE Scale: Strongly agree, agree, slightly agree, slightly disagree, disagree, strongly disagree
Measured: 6 months
Whether the intervention improves patient perceptions of ward atmosphere.
Using the VOICE Scale: Strongly agree, agree, slightly agree, slightly disagree, disagree, strongly disagree
Measured: 6 months
Whether the intervention reduces staff burnout.
Using Maslach Burnout Inventory questionnaire
MBI:
Scale:0 = Never, 1 = a few times a year or less, 2 = once a more or less, 3= a few times a month, 4 = once a week, 5 = a few times a week, 6 = every day.
Duration: Based on 22 statements the participant is to note from 0-6 next to the statement that bests describes how frequently they feel that way.
Score: The participants receive an emotional exhaustion score (EE) (Qs 1,2,3,6,8,13,14,16,20). A depersonalization score (Dep) (Qs 5,10,11,15,22) A professional accomplishment score (PA) (Qs 4,7,9,12,17,18,19,21). EE score is High (27 or over), Moderate (17-26) and low (0-16). Dep score is high (13 or over), Moderate (7-12) or Low (0-6). PA score is high (39 or over), moderate (32-38) or low (0-31).
Measured: Baseline, 6 months and 9 months
Cost-effectiveness of the psychological service model using health economic measures.
Using Health Economics measures (using service use questionnaires) Service use inventory developed from CSRI.
Measured: Baseline, 6 months and 9 months
Identify contextual factors that promote/inhibit implementation and routine incorporation of psychologically-informed care and therapies into everyday practice.
Using implementation fidelity data from the psychologist and ward nurses
Measured: 6 months
Identify contextual factors that promote/inhibit implementation and routine incorporation of psychologically-informed care and therapies into everyday practice.
Using observation data - observe 6 chosen intervention wards
Measured: 6 months
Identify contextual factors that promote/inhibit implementation and routine incorporation of psychologically-informed care and therapies into everyday practice.
Using interview data - interviews with patients and staff on intervention wards
Measured: 6 months
Whether the intervention improves social functioning.
Using Personal and Social Performance Scale. One for the a-c areas and one specific to the d area.
Degrees of severity areas a-c. Degrees of severity area d. Absent, Mild, Manifest, Marked, Severe, Very Severe. Overall score of between 0-100 to be given based on the scores for each of the areas (a-d)
Measured: Baseline, 6 months and 9 months
Improves quality of life
EQ-5D-5L:
Each of the 5 dimensions comprising the EQ-5D descriptive system is divided into 5 levels of perceived problems:
Level 1: indicating no problem Level 2: indicating slight problems Level 3: indicating moderate problems Level 4: indicating severe problems Level 5: indicating extreme problems A unique health state is defined by combining 1 level from each of the 5 dimensions.
Scoring: level 1 is coded as 1, level 2 as 2, level 3 as 3, level 4 as 4 and level 5 as 5. There should be only ONE response for each dimension NB: Missing values can be coded as '9'.NB: Ambiguous values (e.g. 2 boxes are ticked for a single dimension) should be treated as missing values. The EQ VAS should be coded as per where the X is placed on a scale of 0-100 with 100= the best health and 0= the worst health. Missing values should be coded as '999'.
Measured: Baseline, 6 months and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start21 Oct 2019
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trials Unit, Manchester
- Responsible party
- Principal investigator, Dr Katherine Berry, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950388
- Sponsor's protocol ID
- R122297
- Acronym
- TULIPS
- Status last verified
- Sep 2021
- First submitted
- 18 Apr 2019
- Last updated
- 29 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40155872Berry K, Raphael J, Wilson H, Bucci S, Drake RJ, Edge D, Emsley R, Gilworth G, Lovell K, Odebiyi B, Price O, Sutton M, Winter R, Haddock G. A cluster randomised controlled trial of a ward-based intervention to improve access to psychologically-informed care and psychological therapy for mental health in-patients. BMC Psychiatry. 2022 Feb 3;22(1):82. doi: 10.1186/s12888-022-03696-7.
PubMed 35114980
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomised Controlled Trial of a Ward-Based Intervention to Improve Access to Psychologically-Informed Care and Psychological Therapy for Mental Health In-Patients
- ClinicalTrials.gov ID
- NCT03950388
- Acronym / sponsor ID
- TULIPS / R122297
- Conditions
- Mental Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Clinical Trials Unit, Manchester
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | No intervention | – |
| Intervention | Experimental | Behavioral: Intervention |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- 1) Generic, working-age, adult acute mental health wards.
- Consent to complete self-report measures.
- Based on the ward for at least 75% of their working week.
- 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.
Key exclusion criteria (20 listed)
- 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.
- Non-permanent staff, such as bank or agency workers.
- Staff who are planning to leave the ward before the intervention period starts.
- Patients whose discharge is planned for before the start of the intervention period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionWards 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. | Behavioural | Intervention |
Primary outcome
Patient wellbeing
Time frame: Baseline, 6 months and 9 months
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.
Serious incidents on ward
Time frame: Baseline, 3 months, 6 months and 9 months
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
10 secondary outcomes
Whether the intervention improves patients' symptoms
Time frame: Baseline, 6 months and 9 months
Whether the intervention improves staff perceptions of ward atmosphere.
Time frame: 6 months
Whether the intervention improves patient perceptions of ward atmosphere.
Time frame: 6 months
Whether the intervention reduces staff burnout.
Time frame: Baseline, 6 months and 9 months
Cost-effectiveness of the psychological service model using health economic measures.
Time frame: Baseline, 6 months and 9 months
Identify contextual factors that promote/inhibit implementation and routine incorporation of psychologically-informed care and therapies into everyday practice.
Time frame: 6 months
Identify contextual factors that promote/inhibit implementation and routine incorporation of psychologically-informed care and therapies into everyday practice.
Time frame: 6 months
Identify contextual factors that promote/inhibit implementation and routine incorporation of psychologically-informed care and therapies into everyday practice.
Time frame: 6 months
Whether the intervention improves social functioning.
Time frame: Baseline, 6 months and 9 months
Improves quality of life
Time frame: Baseline, 6 months and 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Derived from this study: PubMed 40155872Johnston 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.
- Derived from this study: PubMed 35114980Berry K, Raphael J, Wilson H, Bucci S, Drake RJ, Edge D, Emsley R, Gilworth G, Lovell K, Odebiyi B, Price O, Sutton M, Winter R, Haddock G. A cluster randomised controlled trial of a ward-based intervention to improve access to psychologically-informed care and psychological therapy for mental health in-patients. BMC Psychiatry. 2022 Feb 3;22(1):82. doi: 10.1186/s12888-022-03696-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Mental Health, run by University of Manchester at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katherine Berry (0161 306 0400, katherine.berry@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient wellbeing (time frame: Baseline, 6 months and 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03950388, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.