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

April 17, 2023 updated by: Alexandra Carne, Teesside University

The Impact of Comorbid Chronic Pain on Older Adults With Depression in Behavioral Activation: A Nested Qualitative Sub-Study of Participants in the BASIL+ Trial

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alexandra S Carne, PhD Student
  • Phone Number: 07500784473
  • Email: a.carne@tees.ac.uk

Study Contact Backup

Study Locations

  • United Kingdom
      • Middlesbrough, United Kingdom, TS1 3BX
        • Recruiting
        • Teesside University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alexandra S Carne, PhD Student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

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.

Description

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:

1. Does not fulfill the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Semi-structured Qualitative Interviews

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative interview account
Time Frame: July-2022- July2023
Semi-structured interviews with a topic guide underpinned by a phenomenological framework will be used
July-2022- July2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teesside University

Collaborators

University of York

Investigators

  • Principal Investigator: Alexandra S Carne, PhD Student, Teesside University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2022

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

November 28, 2022

First Submitted That Met QC Criteria

December 7, 2022

First Posted (Actual)

December 12, 2022

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 293203
  • ISRCTN63034289 (Registry Identifier: ISRCTN Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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