Multiple Symptoms Study 3

Not Applicable

Completed

• Conditions: Persistent physical symptoms; Signs and Symptoms

• Registration Number: ISRCTN57050216
• Lead Sponsor: HS Sheffield Clinical Commissioning Group

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36379663/ (added 23/11/2022) 2024 Results article in https://doi.org/10.1016/s0140-6736(24)00700-1 (added 17/06/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-02
• Study Completion: 2023-07-31
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 354

Inclusion Criteria

1. Aged between 18 – 69 years (inclusive) at the time of the computer search
2. Current physical symptoms which meet the below criteria:
2.1. Clinical records suggest MUS (presence of at least one code for an MUS syndrome or at least two codes for negative investigations)
2.2. Records show at least 2 referrals for specialist opinion or diagnostic investigations in the last 3 years
2.3. Records show no evidence of any previous or current major illnesses likely to cause multiple symptoms
2.4. Doctors in the GP practice do not believe that the majority of the patient’s symptoms can be currently explained by other pathology
2.5. The score on the self-completed PHQ-15 symptoms scale is between 10 and 20 (inclusive)

SUB-STUDY - Pen and brief PIS
Any patient identified in the GP mail out as eligible to receive an MSS3 trial invitation pack will be entered into the pen and brief PIS sub-study

Exclusion Criteria

1. A score of 3 on question 9 relating to thoughts of self-harm on the PHQ-9 completed at the baseline visit*
2. Difficulty conducting a healthcare consultation in English without either a professional or family interpreter or other assistance (either indicated in GP records, or becoming apparent during the enrolment and consent process)
3. The GP regards inviting them to participate as inappropriate (e.g. recent bereavement)
4. Severe symptom-related disability (e.g. requiring help with daily personal care or severely impaired mobility)
5. Undergoing active multidisciplinary rehabilitation, IAPT programme or specialist psychological treatment including specialist pain, fatigue or other symptom clinic at the time of screening.
6. Currently pregnant** or less than 6 months postnatal at the time of the screening telephone call

*If a score of 3 is identified at any time point during the study the suicide protocol will be triggered
**if a participant becomes pregnant after the screening telephone call they will remain in the study and continue to attend the Symptoms Clinic Intervention if allocated to the intervention group.

SUB-STUDY - Pen and brief PIS
There are no additional exclusion criteria for the pen and brief PIS sub-study

Study & Design

• Study Type: Interventional
• Study Design: Not specified