Community pharmacies mood intervention study (CHEMIST)

Phase 3

Completed

• Conditions: Depression; Mental and Behavioural Disorders; Mild depressive episode

• Registration Number: ISRCTN11290592
• Lead Sponsor: Tees, Esk and Wear Valleys NHS Foundation Trust

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31161045 protocol (added 05/06/2019) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35115052/ (added 15/02/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35353469/ (added 26/04/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-08
• Study Completion: 2019-11-30
• Last Update Posted: 8 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 68

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)

Exclusion Criteria

Current participant exclusion criteria as of 04/04/2019:
1. Alcohol or drug dependence
2. Cognitive impairment
3. Bipolar disorder or psychosis/psychotic symptoms
4. Actively suicidal (ascertained by eligibility screening interviews)
5. Currently in receipt of psychological therapy

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility Study:<br>1. Recruitment and attrition rates<br>2. Quality of data collection at baseline and 4 months <br>3. ESI adherence<br>4. Process evaluation is undertaken through qualitative interviews with participants, ESI facilitators and pharmacy staff<br><br>Pilot RCT:<br>Self-reported depression severity is measured by the Patient Health Questionnaire (PHQ9) at baseline and 4 months.

Secondary Outcome Measures

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