Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We know that patients may suffer from stress and panic in intensive care. Many patients become fearful and some even see or hear things that are not really happening (hallucinations). Doctors believe these frightening effects are caused by illness, medicine or stressful treatments in intensive care. Research shows that these worries and fears may increase the time it takes for patients to get better. The stress could also lead to future problems like flashbacks or nightmares. Our idea is to give intensive care staff special training to help patients who are worried or distressed. All the staff will learn how to make intensive care a calmer, less stressful place. Some nurses will also have training to give patients extra support to help lower their stress. We believe this will improve patientsÂ’ well-being after leaving intensive care.

Who can participate?
Adult patients receiving treatment in the intensive care can take part.

What does the study involve?
This study consists of two separate parts. Part one is to check that patients are happy to take part and complete a short questionnaire. If we show that patients are happy to do this, we will move on to part two. Part two of the study will test whether training intensive care staff to give stress support can improve patients' future well-being. Patients taking part in part one of the study will receive a short questionnaire 5 months after their stay in intensive care by email or post. Patients taking part in part two of the study will be given a short questionnaire about stress and mood in intensive care. It only takes a few minutes to answer the questions. If the stress score is low, they will continue to receive normal care from the intensive care staff. If they have a high score, one of our specially trained nurses will offer three sessions of stress support. These sessions are to discuss any worries they may have and to help them cope with being in intensive care. They will also receive music and relaxation tapes, and a booklet.

What are the possible benefits and risks of participating?
We cannot promise the study will help patients right now. They will be part of an important study aiming to improve the well-being of intensive care patients. If nurses like the training and patients find the stress support helpful, the study will be held in another 24 hospitals.

Where is the study run from?
The study is being run at four sites in the UK: Bristol Royal Infirmary, Medway Maritime Hospital, University College Hospital, and Watford General Hospital.

When is the study starting and how long is it expected to run for?
The study starts in June 2014 and runs until June 2015.

Who is funding the study?
National Institute for Health Research (NIHR), UK.

Who is the main contact?
Mr Paul Mouncey

Trial website

Contact information



Primary contact

Mr Paul Mouncey


Contact details

Napier House
24 High Holborn
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI): feasibility study



Study hypothesis

The overall aim of the study is to develop and test the feasibility of a complex psychological intervention and to test the feasibility of the processes and procedures for the POPPI cluster randomised controlled trial.

On 10/12/2014 the overall trial end date was changed from 15/12/2014 to 01/06/2015.

Ethics approval

NRES Committee South Central - Oxford B; 23/04/2014; 14/SC/0149

Study design

Non-randomised; Both; Design type: Prevention, Screening, Treatment

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: Critical Care, Mental Health; Subtopic: Critical Care, Anxiety; Disease: All Critical care, Anxiety


The intervention to be assessed is a complex psychological intervention comprising four related elements:
1. An education package (two training courses and associated materials) to train critical care unit staff to carry out elements 2-4
2. Creating a therapeutic environment to promote calm and minimise stress in critical care (all critical care staff)
3. Screening for acute psychological stress and psychosis-like symptoms in critical care patients using the IPAT (all critical care staff)
4. Carrying out three, one-to-one CBT-inspired stress support sessions, for patients screened as distressed and at high risk of psychological morbidity (delivered by specially trained POPPI nurses)

Intervention type



Drug names

Primary outcome measures

The main outcomes of the Intervention Feasibility Study will be the feasibility and acceptability of the intervention for the POPPI nurses and for patients, which will be assessed quantitatively and qualitatively. The main outcomes of the RCT Processes Feasibility Pilot Study are feasibility of estimated recruitment and retention rates.

Secondary outcome measures

Not provided at time of registration

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Age 18 years or greater
2. Receipt of Level 2 or Level 3 critical care for 48 hours or more
3. Between +1 and -1 on the Richmond Agitation Sedation Scale
4. English-speaking and ability to communicate

Participant type


Age group




Target number of participants

Planned Sample Size: 110; UK Sample Size: 110

Participant exclusion criteria

1. Glasgow Coma Score of less than 15
2. Pre-existing chronic cognitive impairment, such as dementia
3. Pre-existing psychotic illness
4. Pre-existing chronic PTSD
5. Terminal illness/receiving end-of-life care

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Bristol Royal Infirmary
Upper Maudlin St
United Kingdom

Trial participating centre

Medway Maritime Hospital
Windmill Rd
United Kingdom

Trial participating centre

University College Hospital
235 Euston Rd Fitzrovia
United Kingdom

Trial participating centre

Watford General Hospital
Vicarage Rd
WD18 0HB
United Kingdom

Sponsor information


Intensive Care National Audit & Research Centre (UK)

Sponsor details

Napier House
24 High Holborn
United Kingdom

Sponsor type

Research organisation



Funder type


Funder name

NIHR Health Services and Delivery Research (UK); Grant Codes: 12/64/124

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes