Condition category
Mental and Behavioural Disorders
Date applied
06/03/2017
Date assigned
08/03/2017
Last edited
08/03/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
About 30% of the UK population has long term physical health problems. Many of those people also suffer from depression, which can end up making their physical health problems worse, lowering their quality of life and doubling healthcare costs. Mild/Sub-Threshold depression often goes undetected and untreated despite the fact it also can worsen a person’s health and functioning and is a major risk factor for depression. A previous study found that a treatment called collaborative care reduced depression symptoms and nearly halved the number of people who developed major depression in older adults with sub-threshold depression. The program included a type of therapy called behavioural activation, which is a short form of cognitive behavioural therapy (a type of talking therapy that helps people change the way they think and behave), and could be run by people with no professional qualifications who are trained/supported by experts. Community pharmacies may provide an excellent setting for this type of program for people with health problems and sub-threshold depression. The aim of this study is to look at whether the treatment can be adapted and if it can be delivered by suitably trained community pharmacy staff to adults with mild depression and long term health problems.

Who can participate?
Depressed adults who have one or more long-term health conditions.

What does the study involve?
In the initial phase of the study, all participants receive the treatment, called ‘Pharmacy Support’. In the second phase of the study a computer randomly allocates (like flipping a coin) participants to receive the Pharmacy Support (50 people) or the usual NHS care (50 people) they normally receive. No treatment is stopped and all participants continue to receive all the care and support they usually do whilst taking part in the study. Participants receiving the Pharmacy Support are contacted by a Healthy Living Advisor from their local pharmacy who arranges their first pharmacy support session. The pharmacy support sessions involve working with a Healthy Living Advisor to plan changes that aim to improve mood and overall wellbeing. The sessions usually take place over the telephone, or if people prefer they can take place face-to-face in their local pharmacy. Participants speak with their Healthy Living Advisor up to 6 times over a four month period and each session lasts for about 15-20 minutes. During the sessions, participants are provided with information to help them think about their difficulties and what they may be able to do to improve some of them, and the Healthy Living Advisor supports them to work through the self-help workbook. All participants in the study are then sent a questionnaire after four months to complete and return to the study team. Participants may also be asked if they would like to take part in an interview to discuss their views about mental wellbeing and the pharmacy support they received as part of the study.

What are the possible benefits and risks of participating?
It is not known whether taking part in this study will help participants, but participants may receive additional support which is not usually available to people from their local pharmacies. Taking part could help improve the treatment offered to people suffering from low mood or depression in the future. There are no anticipated risks to people taking part in the study, but it will take up some of their time to complete the questionnaires and some time will be spent working through the pharmacy support sessions and the associated activities.

Where is the study run from?
The study is run from the University of York and takes place in at least six pharmacies in England (UK)

When is the study starting and how long is it expected to run for?
June 2016 to April 2019

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

Who is the main contact?
1. Dr Liz Littlewood (public)
liz.littlewood@york.ac.uk
2. Dr David Ekers (scientific)
david.ekers@york.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Liz Littlewood

ORCID ID

http://orcid.org/0000-0002-4606-4590

Contact details

Mental Health and Addiction Research Group
Department of Health Sciences
University of York
Heslington
York
YO10 5DD
United Kingdom
+44 1904 321828
liz.littlewood@york.ac.uk

Type

Scientific

Additional contact

Dr David Ekers

ORCID ID

http://orcid.org/0000-0003-3898-3340

Contact details

Mental Health and Addiction Research Group
Department of Health Sciences
University of York
Heslington
York
YO10 5DD
United Kingdom
+44 1904 321638
david.ekers@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32240

Study information

Scientific title

Community pHarmaciEs Mood Intervention STudy (CHEMIST): Feasibility and Pilot Study

Acronym

CHEMIST

Study hypothesis

Feasibility Study:
The aim of the feasibility study is to adapt a bespoke Enhanced Support Intervention for implementation by community pharmacy staff to people with sub-threshold depression and long-term conditions, and to test the proposed study processes (recruitment, assessment, intervention and collection of outcome measures) to be used in the pilot RCT.

Pilot RCT:
The aim of the pilot RCT is to examine delivery of the bespoke Enhanced Support Intervention against usual care in a community pharmacy setting, and to quantify and evaluate the flow of participants (screening, eligibility, recruitment, intervention uptake and retention, and follow-up rate) to determine the feasibility of conducting a larger definitive RCT.

Ethics approval

North East – Newcastle and North Tyneside 2 Research Ethics Committee, 18/11/2016, ref: 16/NE/0327

Study design

Randomised; Interventional; Design type: Treatment, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Specialty: Public health, Primary sub-specialty: Public health; UKCRC code/ Disease: Mental Health/ Mood [affective] disorders

Intervention

Feasibility study:
All participants receive the Enhanced Pharmacy Support Intervention (ESI). The ESI will be adapted for use with individuals with sub-threshold depression and long-term conditions, and will consist of four elements: Behavioural Activation focused self-help support; Proactive follow-up; Symptom monitoring; and Decision supported signposting. It will be delivered by suitably trained pharmacy support staff experienced in delivery of extended pharmacy roles (such as smoking cessation behavioural change approaches) over 4-6 sessions in a 4 month period either over the phone or face-to-face in the privacy of pharmacy consulting rooms. Participants are followed up at 4 months post-recrutiment.

Pilot RCT:
Participants are randomised in a 1:1 ratio using the independent online randomisation service provided by the York Trials Unit) to one of two group.

Intervention group: Participants receive the Enhanced Pharmacy Support Intervention (ESI) over 4-6 sessions in a 4 month period either over the phone or face-to-face in the privacy of pharmacy consulting rooms, as in the feasigbility study.

Control group: Participants receive usual primary care management of sub-threshold depression offered by the GP or other local community provision.

Participants in both groups are followed up at 4 months post-randomisation.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Feasibility Study:
1. Recruitment and attrition rates
2. Quality of data collection at baseline and 4 months
3. ESI adherence
4. Process evaluation is undertaken through qualitative interviews with participants, ESI facilitators and pharmacy staff

Pilot RCT:
Self-reported depression severity is measured by the Patient Health Questionnaire (PHQ9) at baseline and 4 months.

Secondary outcome measures

Pilot RCT:
1. Prevention of depression measured by binary depression scores on the PHQ9 at baseline and 4 months
2. Anxiety is measured using the GAD7 at baseline and 4 months
3. Health Related Quality of Life measured by the SF-12v2 at baseline and 4 months
4. Health State Utility measured by the EQ-5D at baseline and 4 months
5. Health Service Use, collected by a bespoke questionnaire (adapted AD-SUS) at baseline and 4 months
6. Participant’s use of Enhanced Support Intervention, collected from intervention facilitator records at 4 months
7. Process evaluation is undertaken using qualitative interviews with participants, pharmacy staff and GPs at 4 months

Overall trial start date

13/06/2016

Overall trial end date

30/04/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults (male or female, aged 18 years and over)
2. One or more long-term conditions (Arthritis, Cancer, Cardiovascular Conditions, Diabetes, Respiratory Conditions, Stroke).
3. Sub-threshold depression (screen positive with 2-4 symptoms confirmed by diagnostic assessment tool)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 130; UK Sample Size: 130

Participant exclusion criteria

1. Alcohol or drug dependence
2. Cognitive impairment
3. Bipolar disorder or psychosis/psychotic symptoms
4. Aacutely suicidal (ascertained by eligibility screening interviews)
5. Currently in receipt of psychological therapy

Recruitment start date

22/03/2017

Recruitment end date

31/08/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Whitworth – Your Family Pharmacy
17 Beresford Buildings, Thorntree
Middlesbrough
TS3 9NB
United Kingdom

Trial participating centre

Whitworth – Your Family Pharmacy
13-15 Woods Terrace, Murton
Seaham
SR7 9AD
United Kingdom

Trial participating centre

Whitworth – Your Family Pharmacy
7 Healaugh Park
Yarm
TS15 9XN
United Kingdom

Trial participating centre

Norchem, Queens Park Medical Centre
Farrer Street
Stockton-on-Tees
TS18 2AW
United Kingdom

Trial participating centre

Norchem, Crossfell Pharmacy
The Berwick Hills Centre, Ormesby Road
Middlesbrough
TS3 7RP
United Kingdom

Trial participating centre

Marton Pharmacy
4 Marton Estates Square, Stokesley Road, Marton
Middlesbrough
TS7 8DU
United Kingdom

Trial participating centre

University of York
Department of Health Sciences/York Trials Unit Heslington
York
YO10 5DD
United Kingdom

Sponsor information

Organisation

Tees, Esk and Wear Valleys NHS Foundation Trust

Sponsor details

Research and Development
Flatts Lane Centre
Flatts Lane
Normanby
Middlesbrough
TS6 0SZ
United Kingdom
+44 1642 283501
s.daniel@nhs.net

Sponsor type

University/education

Website

https://www.dur.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Dissemination plans include publication of the protocol and pilot RCT outcomes in high-impact peer-reviewed journals. Study summaries will be produced for a range of audiences including service users, health provides and commissioners. The findings will be presented at conferences and disseminated via presentations at a local level (local pharmacy networks and local authorities).

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/12/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes