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Status unknownNCT05646628Updated Apr 20, 2023

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

An observational study in Chronic Pain and Depression, sponsored by Teesside University. Status unknown at 1 site in United Kingdom. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-04-20.

Sponsored by Teesside University · Observational

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
65 Years and older
Sex
All
01

Study 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)

Read the detailed description

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

02

Conditions studied

  • Chronic Pain
  • Depression

Keywords

  • Behavioral Activation
  • Older Adults
03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's planned enrollment of 10 is below the median of 126 across 688 observational studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Teesside University is the lead sponsor of 54 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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.

Exclusion criteria

Exclusion Criteria:

  1. Does not fulfill the inclusion criteria
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • BehavioralQualitative Interviews

    Semi-structured Qualitative Interviews

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What researchers measure

Primary outcomes

  1. Qualitative interview account

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

    Time frame: July-2022- July2023

07

Study locations

1 of 1 sites recruiting
  • Teesside University
    Middlesbrough, TS1 3BX, United Kingdom
    Recruiting
08

References and documents

Publications

  • 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. PubMed 35324908 ↗

Study documents

  • Study protocol · Dec 9, 2022

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05646628
Lead sponsor
Teesside University
Collaborators
University of York
Responsible party
Alexandra Carne (Principle Investigator, Teesside University) — Principal investigator
First posted
Dec 12, 2022
Start date
Nov 28, 2022
Primary completion
Jul 2023 (estimated)
Completion
Mar 2024 (estimated)
Last update
Apr 20, 2023

Study contacts

Alexandra S Carne, PhD Student
Contact
a.carne@tees.ac.uk
07500784473
Denis Martin, Professor
Contact
d.martin@tees.ac.uk
01642242574
Alexandra S Carne, PhD Student
principal investigator · Teesside University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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