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
Conditions: Chronic Pain, Depression
Sponsor: Teesside University

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The Impact of Comorbid Chronic Pain on Older Adults 
Depression and Treatment of Behavioral Activation: A 
Nested Qualitative Sub-Study of Participants in the BASIL+ 
Trial  
 
 
 
 
 
 
 
 
 
 
PROTOCOL (IRAS PROJECT ID 293203) 
 
 
Version 1.2 
 
 
 
 
 
 
Teesside University/ University of York  
School of Health & Life Sciences/ Department of Health 
Sciences  
Teesside University/ University of York  
Middlesbrough, TS1 3BX / York, YO10 5DD 
 
 
 
 
 
 
 
 
 
Version Date: 09/12/2022  
Author: Alexandra Carne 
Chief Investigator: Alexandra Carne  
Supervisors: Denis Martin, Dave Ekers & 
Emma Giles   
Collaborator: Ruth Wadman  

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This study will form part of a National Institute of Health and Care Research (NIHR) North 
East North Cumbria Applied Research collaboration (NENC ARC) funded doctoral research 
study undertaken by a collaborator of the BASIL+ team (Alexandra Carne (AC)). This work will 
be led by AC with support from other members of the BASIL+ team.  
Chronic Pain, also known as persistent pain, is characterised by pain which has 
continued for more than 3 months (1). Chronic pain affects approximately 50-60% of UK 
older adults (2) and often coexists with depression  (3, 4, 5). This comorbid indication affects 
approximately 13% of older adults (6). Pain interference in everyday life increases with age 
(7) and the combination of experiencing both conditions leads to poorer health outcomes 
and overall functioning than experiencing either condition alone (4). 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 when taking antidepressant medication(8) and limited the 
effectiveness of a US collaborative care trial for older adults with depression which 
incorporated problem-solving therapy and antidepressant medication (9). Together, these 
findings suggest that pain may be a potential barrier to depression treatment. It is unknown, 
however, how comorbid chronic pain impacts patients’ engagement in collaborative care 
and more specifically brief psychological therapy such as behavioural activation (BA). The 
BASIL+ trial will provide an opportunity to explore this qualitatively. This sub-study will aim 
to explore if chronic pain impacts patients’ depression and treatment.  
In-depth, semi-structured interviews of a sub-sample of BASIL+ participants will be 
conducted. Potentially eligible participants will include existing BASIL+ participants (those 
participants who have not yet completed their 12 month follow-up) and those BASIL+ 
participants who have completed their 12 month follow up, who were randomised to the BA 
intervention and who expressed experiencing pain as defined as a response of “moderate, 
quite a bit or extremely” on question 8 of the SF-12 at baseline (“During the past 4 weeks, 
how much did pain interfere with your normal work (including work outside the home and 
housework?)”) and/or responded as having “moderate or extreme pain or discomfort” on 
question 4 of the EQ-5D at baseline (“Please indicate which statements best describe your 
own health state today: I have no pain or discomfort, I have moderate pain or discomfort, I 
have extreme pain or discomfort”). This will indicate that these BASIL+ participants were 
experiencing some level of pain at study entry. These baseline data will be provided to AC by 
the BASIL+ statisticians. No other member of the BASIL+ team will have access to these 
baseline data   
 
 
 
 
 
 
 
 
 
Eligibility for this sub-study will be confirmed by AC. This will involve asking 
potentially eligible BASIL+ participants two telephone screening questions which will assess 
how often participants have pain and how pain limits their life/work activities in the last 
three months. This will confirm the presence or absence of chronic pain (10). Participants 
who respond as “never” or “some days” to question 1 (“In the past three months, how often 
did you have pain?”) will be ineligible for the sub-study as chronic pain is absent. These 
BASIL+ participants will be thanked for their time and, where appropriate, will be reminded 

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that a researcher will be in contact for their 12-month follow-up.  Participants who respond 
as “most days” or “everyday” to question 1 will be eligible and will be asked the second 
question (“Over the past three months how often did pain limit your life or work 
activities?”). Participants who respond as “never” or “some days” will be graded as having 
mild/bothersome chronic pain; those who respond as “most days” or everyday” will be 
graded as having high impact chronic pain. For those BASIL+ participants where presence of 
chronic pain is indicated, the BASIL+ statisticians will provide AC with participants' details to 
inform the sampling framework (to include participant ID, age, gender, ethnicity, PHQ9 
baseline scores, EQ-5D baseline scores, SF-12 baseline scores, postcode (for deprivation 
indices) and BA ‘treatment response’ (categorised as either a ‘favourable’ or ‘(non) 
favourable’ response). To define a ‘favourable’ or ‘(non) favourable’ response to the BA 
treatment, a reliable change index of 0.5 SD between participant’s PHQ9 scores at 
screening/baseline and three month post-randomisation (primary outcome measure) will 
provide the best opportunity to identify participants who have responded favourably and 
‘(non) favourably’ to the BASIL+ BA intervention. The change index will provide a general 
idea of how participants responded to the BA intervention which will be discussed further in 
the sub-study interview.  The above data will be provided to AC by the BASIL+ statisticians. 
No other member of the BASIL+ team will have access to these data.  
Approximately 10 participants will be recruited initially. If after the initial 
recruitment round new themes are still arising, then further rounds of recruiting three 
participants at a time will be conducted until no new pertinent themes are arising, or unless 
no eligible participants remain to be approached. Participants will not be approached about 
this sub-study until completion of their BASIL+ primary outcome assessment (at 3 months 
post-randomisation).  
The existing BASIL+ participant information sheet advises participants that they may 
be approached to provide their feedback on their experiences of taking part in the BASIL+ 
study (see section 4.5). The BASIL+ team will provide AC with a list of BASIL+ participants 
who were randomised to the intervention and who have either not yet completed their 12 
month follow up (existing BASIL+ participants) or who have completed their 12 month 
follow up. This list will include only those BASIL+ participants who provided their consent to 
participate in a qualitative interview as part of the BASIL+ study (as outlined in section 4.5). 
For those participants who have completed their 12 month follow up, the eligible 
participant list will include only those participants who also provided their consent (as part 
of their consent to join BASIL+) to be contacted (by the BASIL+ team) about future related 
studies.  
 
 
 
 
 
 
 
 
 
 
 
In addition, participants who took part in or have been approached for the BASIL+ 
qualitative study (see section 4.6) or the therapeutic alliance sub-study (see section 4.15) 
will not be approached for this chronic pain sub-study and will be removed from the eligible 
participant list. Equally, any participants invited to or who participate in this sub-study will 
be relayed back to the BASIL+ qualitative team and ER so they are not approached for their 

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respective qualitative studies. This will ensure no participants are contacted for more than 
one qualitative study and, therefore, reduce any further participant burden  
AC will contact potential participants by telephone to invite them to provide their 
feedback on the sub-study and how their potential pain impacted their depression and 
experience of the ‘BA Support’ (BA intervention) in the BASIL+ study. If participants are 
interested, verbal consent to screen for confirmation of chronic pain will be received and 
recorded. Participants who do not wish to answer these questions will be thanked for their 
time and will not complete an interview. AC will ask participants in the last three months 
how often they have had pain and how often pain limited life or work activities(10). 
Participants whose responses to these questions indicate the presence of chronic pain will 
be asked if they would like to take part in this sub-study.  
For those participants who meet the sub-study criteria and are willing to complete 
an interview, AC will confirm a date and time suitable for the participant to have the 
interview and the participant’s preferred method of meeting either by telephone or via an 
approved virtual platform. Verbal consent for each participant will be received before the 
interview commences and will be audio recorded (as detailed in section 4.13). The interview 
should last approximately 45 minutes. Where real or potential risk is identified during the 
interviews AC will follow all appropriate and robust BASIL+ risk protocols (see section 6.6 for 
risk management).   
All interviews will be digitally recorded (with participant consent) on an encrypted 
Dictaphone (or any other approved method), anonymised and transcribed. Transcription of 
the audio recordings will be completed by AC or via an approved transcription service. The 
transcripts will form the data for analysis. The audio recordings and any electronic 
transcriptions will be stored securely on password-protected secure servers at the 
University of York with access limited as relevant to the delivery of this sub-study. The 
interview topic guide has been developed in consultation with the BASIL+ team, AC’s PhD 
supervisors (experts in chronic pain, behavioural activation, and qualitative methodology). 
The topic guide will be piloted with the first two participants and amended iteratively if 
required.  
Thematic analysis (based on Braun and Clarke (11, 12) will be used to analyse the 
data to understand the nature of people's experiences (i.e phenomenology). Codes will be 
generated from the transcripts which will form themes, these themes will be reviewed, 
defined, and reported.  
This chronic pain sub-study forms part of AC’s doctoral research. A quantitative 
effect modification study is being undertaken simultaneously based on data from three of 
the largest BA trials in the UK (CASPER (13), CASPER+ (14) and SHARD (15)) in a mixed-
methods design. The results of these two studies together will indicate to what extent pain 
impacts depression and potentially identify sub-groups of individuals in which BA is less 
effective. This will inform the next stage of this doctoral research which will continue under 
the wider MODS programme of research. 
 

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This study will form part of a National Institute of Health and Care Research (NIHR) North 
East North Cumbria Applied Research collaboration (NENC ARC) funded doctoral research 
study undertaken by a collaborator of the BASIL+ team (Alexandra Carne (AC)). This work will 
be led by AC with support from other members of the BASIL+ team.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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