Last updated: April 17, 2023
Sponsor: Teesside University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Depression
Pain
Chronic Pain
Treatment
N/AClinical Study ID
NCT05646628
293203
ISRCTN63034289
Ages > 65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Previously provided optional consent to participate in a qualitative study as part ofthe BASIL+ trial
- Not enrolled or offered to take part in any other qualitative study linked with theBASIL+ trial (i.e, the nested BASIL+ qualitative study or the therapeutic alliancesub-study)
- Suffering chronic pain. This will be assumed by individual scores on the (short-from
- SF-12 and EuroQoal 5th Edition (EQ-5D) at baseline in the BASIL + trial. Patientswho have responded as "moderate, quite a bit or extremely" on question 8 of the SF-12at baseline and/or responded as having "moderate or extreme pain or discomfort" on theEQ-5D question 4 at baseline will be "assumed" to experiencing some level of pain. Afurther 2 telephone screening questions by the PI of this sub-study (Alexandra Carne)will assess how often patients have pain and how pain limits their life/workactivities in the last 3 months. This will confirm the presence of chronic pain.
- Participants will have had either a 'favourable' or 'non' favourable' response totreatment. This is defined as having a change of 0.5 SD on the PHQ-9 from baseline tothe primary outcome point at 3 months.
Exclusion
Exclusion Criteria:
- Does not fulfill the inclusion criteria
Study Design
Total Participants: 10
Study Start date:
November 28, 2022
Estimated Completion Date:
March 31, 2024
Study Description
Connect with a study center
Teesside University
Middlesbrough, TS1 3BX
United KingdomActive - Recruiting
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