Mental Health DisorderNCT05303870
Impact of Psychological Therapies on Emergency Medical Patients
A study testing Improving access to psychological therapies (IAPT) in people with Mental Health Disorder and Mental Disorder, run by East Suffolk and North Essex NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Prevalence of anxiety and depression in the general population is known, but is under researched in the acute hospital setting and there is little evidence on the prevalence of anxiety and depression within the emergency medical admission population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Disorder, Mental Disorder, Mental Health Wellness 1
- What is being tested?
- Improving access to psychological therapies (IAPT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Oct 2021to 27 Mar 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients admitted to Ipswich Hospital into a ward that cares for patients who are medical emergencies.
- Patients who score 3 or higher on one or both of the GAD 2 and PHQ 2.
- Patients that have capacity to consent.
- Over 18 years old.
- Ability to speak and read in English as the study will not have the resources to employ interpreters or to get documentation translated.
- Participants that are not deemed suicidal via screening and medical and nurse assessment.
Who cannot join
- Patients not receiving care on a ward caring for medical emergencies.
- Patients under the age of 18 years old.
- Patients scoring < 3 on both GAD 2 and PHQ 2.
- Patients who do not have capacity to consent.
- Participants that are suicidal as via screening and medical and nurse assessment.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
East Suffolk and North Essex NHS Foundation Trust
Ipswich, IP4 5PD
About this study
Official title: Exploring the Transferability of Improving Access to Psychological Therapies (IAPT) to a General Hospital Emergency Inpatient Ward
Prevalence of anxiety and depression in the general population is known, but is under researched in the acute hospital setting and there is little evidence on the prevalence of anxiety and depression within the emergency medical admission population. A potential intervention for treating such mental health prevalence would be in the form of IAPT methodology which has been utilised in other parts of the NHS demonstrating good outcomes. Therefore, this feasibility study will explore the utility of IAPT in the acute setting.
This study will explore the prevalence of anxiety and depression in the emergency medical population within medical inpatient wards , utilising the assessment tools adopted by the IAPT services and explained in detail below.
The study will explore a) feasibility of introducing psychological intervention to an emergency medical ward and b) provide preliminary data on the outcome of this intervention on hospital length of stay and readmission rates.
- Being tested
- Improving access to psychological therapies (IAPT)
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improving access to psychological therapies (IAPT)Other
IAPT services provide evidence-based treatments for people with depression and anxiety disorders, and comorbid long-term physical health conditions or medically unexplained symptoms. IAPT services are characterised by three key principles:
- Evidence-Based psychological therapies at the appropriate dose: NICE recommended therapies matched to the mental health problem, at the intensity and duration designed to optimise outcomes.
- Appropriately trained and supervised workforce.
- Routine outcome monitoring.
| Study group | Role | What they receive |
|---|---|---|
| IAPT | Experimental | Not described Receives: Other: Improving access to psychological therapies (IAPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with moderate or severe anxiety
How many participants enrol in to the study, that are eligible to participate.
Measured: Up to 6 months
Secondary outcomes (1)
IAPT views
Thematic analysis of in depth interviews on staff and patients regarding the IAPT intervention.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start10 Oct 2021
- Primary completion27 Mar 2022
- Study completion27 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health DisorderStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Suffolk and North Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Essex
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303870
- Sponsor's protocol ID
- 20/024
- Status last verified
- Jul 2022
- First submitted
- 21 Feb 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Transferability of Improving Access to Psychological Therapies (IAPT) to a General Hospital Emergency Inpatient Ward
- ClinicalTrials.gov ID
- NCT05303870
- Acronym / sponsor ID
- 20/024
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- East Suffolk and North Essex NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Essex
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 27 Mar 2022 (actual)
- Study completion
- 27 Mar 2022 (actual)
- First posted
- 31 Mar 2022 (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.
Prevalence of anxiety and depression in the general population is known, but is under researched in the acute hospital setting and there is little evidence on the prevalence of anxiety and depression within the emergency medical admission population. A potential intervention for treating such mental health prevalence would be in the form of IAPT methodology which has been utilised in other parts of the NHS demonstrating good outcomes. Therefore, this feasibility study will explore the utility of IAPT in the acute setting.
This study will explore the prevalence of anxiety and depression in the emergency medical population within medical inpatient wards , utilising the assessment tools adopted by the IAPT services and explained in detail below.
The study will explore a) feasibility of introducing psychological intervention to an emergency medical ward and b) provide preliminary data on the outcome of this intervention on hospital length of stay and readmission rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IAPT | Experimental | Other: Improving access to psychological therapies (IAPT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients admitted to Ipswich Hospital into a ward that cares for patients who are medical emergencies.
- Patients who score 3 or higher on one or both of the GAD 2 and PHQ 2.
- Patients that have capacity to consent.
- Over 18 years old.
- Ability to speak and read in English as the study will not have the resources to employ interpreters or to get documentation translated.
Key exclusion criteria (5 listed)
- Patients not receiving care on a ward caring for medical emergencies.
- Patients under the age of 18 years old.
- Patients scoring < 3 on both GAD 2 and PHQ 2.
- Patients who do not have capacity to consent.
- Participants that are suicidal as via screening and medical and nurse assessment.
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 |
|---|---|---|
| Improving access to psychological therapies (IAPT)IAPT services provide evidence-based treatments for people with depression and anxiety disorders, and comorbid long-term physical health conditions or medically unexplained symptoms. IAPT services are characterised by three key principles: 1. Evidence-Based psychological therapies at the appropriate dose: NICE recommended therapies matched to the mental health problem, at the intensity and duration designed to optimise outcomes. 2. Appropriately trained and supervised workforce. 3. Routine outcome monitoring. | Other | IAPT |
Primary outcome
Number of participants with moderate or severe anxiety
Time frame: Up to 6 months
How many participants enrol in to the study, that are eligible to participate.
1 secondary outcome
IAPT views
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Improving access to psychological therapies (IAPT) in people with Mental Health Disorder and Mental Disorder, run by East Suffolk and North Essex NHS Foundation Trust at 1 site 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with moderate or severe anxiety (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2022.