The Impact of Comorbid Chronic Pain on Older Adults With Depression in Behavioral Activation

NCT05646628 | Unknown

• 2 other identifiers: 293203ISRCTN63034289
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This qualitative nested sub-study will aim to explore how chronic pain (as defined as pain lasting for more than 3 months) impacts older adults' depression and treatment in a brief psychological therapy of behavioral activation (BA)

Conditions

Chronic Pain; Depression

Keywords

Behavioral Activation; Older Adults

Outcome Measures

Primary Outcomes (1)

• Qualitative interview account

  Semi-structured interviews with a topic guide underpinned by a phenomenological framework will be used

  July-2022- July2023

Study Arms (1)

Participants

Older adults (aged 65 years and over) enrolled in the BASIL+ trial randomized to receive the intervention (collaborative care focusing on behavioral activation) and confirmed as having chronic pain

Behavioral: Qualitative Interviews

Interventions

Qualitative Interviews BEHAVIORAL

Semi-structured Qualitative Interviews

Participants

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be aged 65 years and older who have depression and were randomized in the BASIL + trial to receive the intervention (collaborative care focusing on behavioral activation) and have been identified as having persistent pain. To ensure maximum diversity, a range of ages, gender, ethnicities and deprivation will be included.

You may qualify if:

• Previously provided optional consent to participate in a qualitative study as part of the BASIL+ trial
• Not enrolled or offered to take part in any other qualitative study linked with the BASIL+ trial (i.e, the nested BASIL+ qualitative study or the therapeutic alliance sub-study)
• Suffering chronic pain. This will be assumed by individual scores on the (short-from 12) SF-12 and EuroQoal 5th Edition (EQ-5D) at baseline in the BASIL + trial. Patients who have responded as "moderate, quite a bit or extremely" on question 8 of the SF-12 at baseline and/or responded as having "moderate or extreme pain or discomfort" on the EQ-5D question 4 at baseline will be "assumed" to experiencing some level of pain. A further 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/work activities in the last 3 months. This will confirm the presence of chronic pain.
• Participants will have had either a 'favourable' or 'non' favourable' response to treatment. This is defined as having a change of 0.5 SD on the PHQ-9 from baseline to the primary outcome point at 3 months.

Sponsors & Collaborators

• Teesside University: lead
• University of York: collaborator

Study Sites (1)

Teesside University

Middlesbrough, TS1 3BX, United Kingdom

RECRUITING

Related Publications (1)

• Burke L, Littlewood E, Gascoyne S, McMillan D, Chew-Graham CA, Bailey D, Sloan C, Fairhurst C, Baird K, Hewitt C, Henry A, Ryde E, Shearsmith L, Coventry P, Crosland S, Newbronner E, Traviss-Turner G, Woodhouse R, Clegg A, Gentry T, Hill A, Lovell K, Dexter Smith S, Webster J, Ekers D, Gilbody S. Behavioural Activation for Social IsoLation (BASIL+) trial (Behavioural activation to mitigate depression and loneliness among older people with long-term conditions): Protocol for a fully-powered pragmatic randomised controlled trial. PLoS One. 2022 Mar 24;17(3):e0263856. doi: 10.1371/journal.pone.0263856. eCollection 2022.

  PMID: 35324908 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Depression

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Alexandra S Carne, PhD Student

  Teesside University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra S Carne, PhD Student

CONTACT

07500784473; a.carne@tees.ac.uk

Denis Martin, Professor

CONTACT

01642242574; d.martin@tees.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 12, 2022
• Study Start: November 28, 2022
• Primary Completion: July 1, 2023
• Study Completion: March 1, 2024
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

GB (1)