The Impact of Comorbid Chronic Pain on Older Adults With Depression in Behavioral Activation
NCT ID: NCT05646628
Last Updated: 2023-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
10 participants
OBSERVATIONAL
2022-11-28
2024-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Impact of Pain on Depression Outcomes
NCT05477758
A Modified Behavioral Activation Treatment for Geriatric Depressive Symptoms in Left-behind Elderly in Rural China
NCT02785211
Effectiveness of a Self-care Intervention for Depression in Primary Care Patients With Chronic Physical Illnesses
NCT01521013
Developing a Self-Management Program for People With Depression and Chronic Medical Illness
NCT00523029
A Tripartite Biopsychosocial Intervention Program Enhances Mental Health and Quality of Life in Elderly Patients With Depression Secondary to Geriatric Diseases
NCT07002385
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Semi-structured Qualitative Interviews
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Qualitative Interviews
Semi-structured Qualitative Interviews
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of York
OTHER
Teesside University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Alexandra Carne
Principle Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alexandra S Carne, PhD Student
Role: PRINCIPAL_INVESTIGATOR
Teesside University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Teesside University
Middlesbrough, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ISRCTN63034289
Identifier Type: REGISTRY
Identifier Source: secondary_id
293203
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.