- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03950388
Trial of a Ward-Based Intervention to Improve Access to Psychologically-Informed Care and Psychological Therapy for Mental Health In-Patients (TULIPS)
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
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Katherine Berry
- Phone Number: 0161 306 0400
- Email: katherine.berry@manchester.ac.uk
Study Locations
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-
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Leeds, United Kingdom
- Recruiting
- Leed & York Partnership NHS Foundation Trust
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Contact:
- Crystal-Bella Romain-Hooper
- Email: c.romain-hooper@nhs.net
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Greater Manchester
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Manchester, Greater Manchester, United Kingdom
- Recruiting
- Greater Manchester Mental Health NHS Foundation Trust
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Contact:
- Jessica Raphael
- Email: jessica.raphael@manchester.ac.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention
|
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.
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NO_INTERVENTION: Treatment as Usual
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline, 6 months and 9 months
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Serious incidents on ward
Time Frame: Baseline, 3 months, 6 months and 9 months
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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
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Baseline, 3 months, 6 months and 9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whether the intervention improves patients' symptoms
Time Frame: Baseline, 6 months and 9 months
|
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:
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Baseline, 6 months and 9 months
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Whether the intervention improves staff perceptions of ward atmosphere.
Time Frame: 6 months
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Using the VOTE Scale: Strongly agree, agree, slightly agree, slightly disagree, disagree, strongly disagree
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6 months
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Whether the intervention improves patient perceptions of ward atmosphere.
Time Frame: 6 months
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Using the VOICE Scale: Strongly agree, agree, slightly agree, slightly disagree, disagree, strongly disagree
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6 months
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Whether the intervention reduces staff burnout.
Time Frame: Baseline, 6 months and 9 months
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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). |
Baseline, 6 months and 9 months
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Cost-effectiveness of the psychological service model using health economic measures.
Time Frame: Baseline, 6 months and 9 months
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Using Health Economics measures (using service use questionnaires) Service use inventory developed from CSRI.
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Baseline, 6 months and 9 months
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Identify contextual factors that promote/inhibit implementation and routine incorporation of psychologically-informed care and therapies into everyday practice.
Time Frame: 6 months
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Using implementation fidelity data from the psychologist and ward nurses
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6 months
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Identify contextual factors that promote/inhibit implementation and routine incorporation of psychologically-informed care and therapies into everyday practice.
Time Frame: 6 months
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Using observation data - observe 6 chosen intervention wards
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6 months
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Identify contextual factors that promote/inhibit implementation and routine incorporation of psychologically-informed care and therapies into everyday practice.
Time Frame: 6 months
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Using interview data - interviews with patients and staff on intervention wards
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6 months
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Whether the intervention improves social functioning.
Time Frame: Baseline, 6 months and 9 months
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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) |
Baseline, 6 months and 9 months
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Improves quality of life
Time Frame: Baseline, 6 months and 9 months
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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'. |
Baseline, 6 months and 9 months
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R122297
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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