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

NCT ID: NCT05646628

Last Updated: 2023-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-28

Study Completion Date

2024-03-31

Brief Summary

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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)

Detailed Description

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The BASIL + trial (Behavioral Activation in Social Isolation) is a National Institute of Health Research (NIHR) funded and approved trial sponsored by Tees, Esk and Wear Valleys NHS Foundation Trust (TEWV) and led by the University of York in the United Kingdom (UK).

Behavioral Activation (BA) is a type of support that may be beneficial for individuals who suffer from social isolation and/ or depression symptoms. BA assists in the continuation or introduction of activities that are significant to patients. These exercises may be beneficial to both physical and emotional health.

The BASIL+ study aims to find out if BA helps reduce or prevent depression and loneliness in older adults who have ongoing health conditions during isolation in the pandemic due to COVID-19.

Chronic pain affects approximately 50-60% of UK older adults and often coexists with depression. This comorbid indication affects approximately 13% of older adults. The literature on the impact of pain on depression outcomes has been steadily rising. Patients who suffer from depression with comorbid pain report significantly lower benefits, including less relief from depressive symptoms and limits the effectiveness of collaborative care for older adults with depression in the US. The collaborative care focused on antidepressant therapy and problem-solving therapy. Together, these findings suggest that pain may be a potential barrier to depression treatment response. It is unknown, however, how chronic pain impacts depression and the treatment of BA.

This sub-study nested in the BASIL+ trial provides an opportunity to explore how chronic pain impacts depression and the treatment they received

Conditions

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Chronic Pain Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Qualitative Interviews

Intervention Type BEHAVIORAL

Semi-structured Qualitative Interviews

Interventions

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Qualitative Interviews

Semi-structured Qualitative Interviews

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Previously provided optional consent to participate in a qualitative study as part of the BASIL+ trial
2. 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)
3. 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.
4. 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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of York

OTHER

Sponsor Role collaborator

Teesside University

OTHER

Sponsor Role lead

Responsible Party

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Alexandra Carne

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexandra S Carne, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Teesside University

Locations

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Teesside University

Middlesbrough, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Alexandra S Carne, PhD Student

Role: CONTACT

07500784473

Denis Martin, Professor

Role: CONTACT

01642242574

Facility Contacts

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Alexandra S Carne, PhD Student

Role: primary

Denis Martin, Professor

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 35324908 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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ISRCTN63034289

Identifier Type: REGISTRY

Identifier Source: secondary_id

293203

Identifier Type: -

Identifier Source: org_study_id

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