PainNCT05477758
The Impact of Pain on Depression Outcomes
An observational study of Pain and Depression, run by Teesside University at 1 site in United Kingdom.
Trial summary
This study is a secondary data analysis of three of largest Randomised Controlled Trials (RCTs) of behavioural activation (BA) for older people with depression in the United Kingdom (UK) primary care. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pain, Depression
- What is being tested?
- Collaborative care, Usual General Practitioner (GP) care and Behavioral Activation Self-Help guide
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,522 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Sep 2022to Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients were aged 65 years or older with subthreshold depression (CASPER and SHARD) or case-level depression (CASPER+)
Who may be able to join
- Patients who participated in CASPER, CASPER + or SHARD study
Who cannot join
- Anyone who did not consent into one of the three studies above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Pain on Depression Outcomes of Older Adults in Behavioural Activation: An Exploratory Secondary Data Analysis
This study is a secondary data analysis of three of largest Randomised Controlled Trials (RCTs) of behavioural activation (BA) for older people with depression in the United Kingdom (UK) primary care. The analysis will aim to explore the impact of pain on depression outcomes of older people receiving BA and potentially identify sub-groups of people who may not respond as well to treatment.
Read the detailed description
Previous findings have indicated that pain might be an important barrier in depression treatment both with antidepressant medication and in a United States (US) collaborative care model using problem solving therapy and antidepressant medication. It is unknown, however, if pain impacts depression outcomes of older adults in a collaborative care (CC) framework focusing on a brief psychological intervention of BA. Collectively CASPER, CASPER PLUS (+) and SHARD are three of the largest pragmatic, multi-centre randomised controlled trials (RCT) of BA for older adults in UK primary care with low mood and depression. The purpose of this secondary data analysis is, therefore, to explore if pain moderates (modifies) the effect of BA on depression outcomes in older adults, potentially identifying subgroups of older adults who may not respond as well to BA.
- Conditions
- Pain, Depression
- Being tested
- Collaborative care, Usual General Practitioner (GP) care, Behavioral Activation Self-Help guide
- Keywords
- Older Adults, Behavioural Activation
- Medical subject headings
- Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative careBehavioural
Also called behavioural activation
Participants in the intervention group were allocated a receive a low-intensity programme of behavioural activation specifically designed for adults ≥65 with subthreshold depression. An allocated case manager (primary care mental health worker/ Improving Access to Psychological Therapy) delivered collaborative care for an intended 8-10 weeks. This ran alongside general practitioner (GP) usual care. Collaborative care in both CASPER and CASPER+ trial included weakly telephone/ face-to-face support, active surveillance and symptom monitoring
Usual General Practitioner (GP) careOther
Participants allocated to the control group received usual GP care. Participants did not receive any additional care to their usual primary care management for subthreshold (CASPER) or Major (CASPER+) depression in line with National Institute for Health and Care Excellence (NICE) guidelines as implemented in their GP and local service provision.
Behavioral Activation Self-Help guideBehavioural
Participants in the intervention arm were provided with a self-help booklet based on clear principles of BA for depression. The purpose of the booklet was to introduce simple behavioural strategies for improving mood. Participants were encouraged to (1) re-establish their daily routine, (2) increase meaningful activities and (3) reduce avoidance behaviours. Participants also received 3 phone calls at week 1, 3 and 6 designed to check the booklet had arrived and to encourage the use of the materials. All participants received their usual GP care
| Study group | Role | What they receive |
|---|---|---|
| CASPER | A multi-centred, pragmatic, two-arm parallel open RCT. Participants with Subthreshold depression were individually randomised (1:1) to receive either collaborative care focusing on behavioural activation or usual GP care Receives: Behavioral: Collaborative care; Other: Usual General Practitioner (GP) care | |
| CASPER+ | A multi-centred, pragmatic, two-arm parallel open RCT. Participants with Major depression were individually randomised (1:1) to receive either collaborative care focusing on behavioural activation or usual GP care Receives: Behavioral: Collaborative care; Other: Usual General Practitioner (GP) care | |
| SHARD | A multi-centred, pragmatic, two-arm parallel open RCT. Participants with Subthreshold depression were individually randomised (1:1) to receive the self-help booklet based on the principles of behavioural activation or usual GP care Receives: Other: Usual General Practitioner (GP) care; Behavioral: Behavioral Activation Self-Help guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
PhQ-9 (Patient Health Questionnaire- 9
5 point likert scale ranging from 0 to 27. Higher points denote worse depression. The instrument is used for screening, diagnosing, monitoring and measuring the severity of depression in primary care.
Measured: Baseline
PhQ-9 (Patient Health Questionnaire- 9
5 point likert scale ranging from 0 to 27. Higher points denote worse depression. The instrument is used for screening, diagnosing, monitoring and measuring the severity of depression in primary care.
Measured: 4 months
SF-12 (Short Form- 12)
The instrument is a generic health status measure consisting of 12 questions measuring 8 domains. Question 8 referring to bodily pain will be used for the moderation analysis. The tool has a likhert scale of 1-5 with 5 denotating worse pain.
Measured: Baseline
EQ-5D (Euroqual Group)
The EQ-5D consists of 5 questions assessing the various quality of life dimensions including mobility, self-care, usual activities, Pain/Discomfort and Anxiety/Depression. Each dimension is rated on three levels: no problem (score=1) some problems (score=2) and extreme problems (score=3). Question 4 relating to pain/discomfort will be used as a second indicator for the pain moderator.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start15 Sep 2022
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,522 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Collaborators
- University of York
- Responsible party
- Principal investigator, Alexandra Carne, Teesside University
- Investigators
- Alexandra S Carne, PhD Student, Principal investigator, Teesside University/ Univeristy of York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477758
- Sponsor's protocol ID
- 8838
- Other IDs
- ISRCTN02202951, ISRCTN45842879, ISRCTN95270332
- Status last verified
- Apr 2023
- First submitted
- 12 Jul 2022
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bosanquet K, Adamson J, Atherton K, Bailey D, Baxter C, Beresford-Dent J, Birtwistle J, Chew-Graham C, Clare E, Delgadillo J, Ekers D, Foster D, Gabe R, Gascoyne S, Haley L, Hamilton J, Hargate R, Hewitt C, Holmes J, Keding A, Lewis H, McMillan D, Meer S, Mitchell N, Nutbrown S, Overend K, Parrott S, Pervin J, Richards DA, Spilsbury K, Torgerson D, Traviss-Turner G, Trepel D, Woodhouse R, Gilbody S. CollAborative care for Screen-Positive EldeRs with major depression (CASPER plus): a multicentred randomised controlled trial of clinical effectiveness and cost-effectiveness. Health Technol Assess. 2017 Nov;21(67):1-252. doi: 10.3310/hta21670.
PubMed 29171379Gilbody S, Brabyn S, Mitchell A, Ekers D, McMillan D, Bailey D, Hems D, Chew Graham CA, Keding A, Bosanquet K; SHARD collaborative. Can We Prevent Depression in At-Risk Older Adults Using Self-Help? The UK SHARD Trial of Behavioral Activation. Am J Geriatr Psychiatry. 2022 Feb;30(2):197-207. doi: 10.1016/j.jagp.2021.06.006. Epub 2021 Jun 19.
PubMed 34266750Lewis H, Adamson J, Atherton K, Bailey D, Birtwistle J, Bosanquet K, Clare E, Delgadillo J, Ekers D, Foster D, Gabe R, Gascoyne S, Haley L, Hargate R, Hewitt C, Holmes J, Keding A, Lilley-Kelly A, Maya J, McMillan D, Meer S, Meredith J, Mitchell N, Nutbrown S, Overend K, Pasterfield M, Richards D, Spilsbury K, Torgerson D, Traviss-Turner G, Trepel D, Woodhouse R, Ziegler F, Gilbody S. CollAborative care and active surveillance for Screen-Positive EldeRs with subthreshold depression (CASPER): a multicentred randomised controlled trial of clinical effectiveness and cost-effectiveness. Health Technol Assess. 2017 Feb;21(8):1-196. doi: 10.3310/hta21080.
PubMed 28248154
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pain on Depression Outcomes of Older Adults in Behavioural Activation: An Exploratory Secondary Data Analysis
- ClinicalTrials.gov ID
- NCT05477758
- Acronym / sponsor ID
- 8838
- Conditions
- Pain, Depression
- Keywords
- Older Adults, Behavioural Activation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,522 participants (estimated)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Collaborators
- University of York
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a secondary data analysis of three of largest Randomised Controlled Trials (RCTs) of behavioural activation (BA) for older people with depression in the United Kingdom (UK) primary care. The analysis will aim to explore the impact of pain on depression outcomes of older people receiving BA and potentially identify sub-groups of people who may not respond as well to treatment.
Detailed description
Previous findings have indicated that pain might be an important barrier in depression treatment both with antidepressant medication and in a United States (US) collaborative care model using problem solving therapy and antidepressant medication. It is unknown, however, if pain impacts depression outcomes of older adults in a collaborative care (CC) framework focusing on a brief psychological intervention of BA. Collectively CASPER, CASPER PLUS (+) and SHARD are three of the largest pragmatic, multi-centre randomised controlled trials (RCT) of BA for older adults in UK primary care with low mood and depression. The purpose of this secondary data analysis is, therefore, to explore if pain moderates (modifies) the effect of BA on depression outcomes in older adults, potentially identifying subgroups of older adults who may not respond as well to BA.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CASPER | – | Behavioral: Collaborative care, Other: Usual General Practitioner (GP) careA multi-centred, pragmatic, two-arm parallel open RCT. Participants with Subthreshold depression were individually randomised (1:1) to receive either collaborative care focusing on behavioural activation or usual GP care |
| CASPER+ | – | Behavioral: Collaborative care, Other: Usual General Practitioner (GP) careA multi-centred, pragmatic, two-arm parallel open RCT. Participants with Major depression were individually randomised (1:1) to receive either collaborative care focusing on behavioural activation or usual GP care |
| SHARD | – | Other: Usual General Practitioner (GP) care, Behavioral: Behavioral Activation Self-Help guideA multi-centred, pragmatic, two-arm parallel open RCT. Participants with Subthreshold depression were individually randomised (1:1) to receive the self-help booklet based on the principles of behavioural activation or usual GP care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients were aged 65 years or older with subthreshold depression (CASPER and SHARD) or case-level depression (CASPER+)
Key inclusion criteria (1 listed)
- Patients who participated in CASPER, CASPER + or SHARD study
Key exclusion criteria (1 listed)
- Anyone who did not consent into one of the three studies above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative careAlso: behavioural activationParticipants in the intervention group were allocated a receive a low-intensity programme of behavioural activation specifically designed for adults ≥65 with subthreshold depression. An allocated case manager (primary care mental health worker/ Improving Access to Psychological Therapy) delivered collaborative care for an intended 8-10 weeks. This ran alongside general practitioner (GP) usual care. Collaborative care in both CASPER and CASPER+ trial included weakly telephone/ face-to-face support, active surveillance and symptom monitoring | Behavioural | CASPER, CASPER+ |
| Usual General Practitioner (GP) careParticipants allocated to the control group received usual GP care. Participants did not receive any additional care to their usual primary care management for subthreshold (CASPER) or Major (CASPER+) depression in line with National Institute for Health and Care Excellence (NICE) guidelines as implemented in their GP and local service provision. | Other | CASPER, CASPER+, SHARD |
| Behavioral Activation Self-Help guideParticipants in the intervention arm were provided with a self-help booklet based on clear principles of BA for depression. The purpose of the booklet was to introduce simple behavioural strategies for improving mood. Participants were encouraged to (1) re-establish their daily routine, (2) increase meaningful activities and (3) reduce avoidance behaviours. Participants also received 3 phone calls at week 1, 3 and 6 designed to check the booklet had arrived and to encourage the use of the materials. All participants received their usual GP care | Behavioural | SHARD |
Primary outcome
PhQ-9 (Patient Health Questionnaire- 9
Time frame: Baseline
5 point likert scale ranging from 0 to 27. Higher points denote worse depression. The instrument is used for screening, diagnosing, monitoring and measuring the severity of depression in primary care.
PhQ-9 (Patient Health Questionnaire- 9
Time frame: 4 months
5 point likert scale ranging from 0 to 27. Higher points denote worse depression. The instrument is used for screening, diagnosing, monitoring and measuring the severity of depression in primary care.
SF-12 (Short Form- 12)
Time frame: Baseline
The instrument is a generic health status measure consisting of 12 questions measuring 8 domains. Question 8 referring to bodily pain will be used for the moderation analysis. The tool has a likhert scale of 1-5 with 5 denotating worse pain.
EQ-5D (Euroqual Group)
Time frame: Baseline
The EQ-5D consists of 5 questions assessing the various quality of life dimensions including mobility, self-care, usual activities, Pain/Discomfort and Anxiety/Depression. Each dimension is rated on three levels: no problem (score=1) some problems (score=2) and extreme problems (score=3). Question 4 relating to pain/discomfort will be used as a second indicator for the pain moderator.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Results publication: PubMed 29171379Bosanquet K, Adamson J, Atherton K, Bailey D, Baxter C, Beresford-Dent J, Birtwistle J, Chew-Graham C, Clare E, Delgadillo J, Ekers D, Foster D, Gabe R, Gascoyne S, Haley L, Hamilton J, Hargate R, Hewitt C, Holmes J, Keding A, Lewis H, McMillan D, Meer S, Mitchell N, Nutbrown S, Overend K, Parrott S, Pervin J, Richards DA, Spilsbury K, Torgerson D, Traviss-Turner G, Trepel D, Woodhouse R, Gilbody S. CollAborative care for Screen-Positive EldeRs with major depression (CASPER plus): a multicentred randomised controlled trial of clinical effectiveness and cost-effectiveness. Health Technol Assess. 2017 Nov;21(67):1-252. doi: 10.3310/hta21670.
- Results publication: PubMed 34266750Gilbody S, Brabyn S, Mitchell A, Ekers D, McMillan D, Bailey D, Hems D, Chew Graham CA, Keding A, Bosanquet K; SHARD collaborative. Can We Prevent Depression in At-Risk Older Adults Using Self-Help? The UK SHARD Trial of Behavioral Activation. Am J Geriatr Psychiatry. 2022 Feb;30(2):197-207. doi: 10.1016/j.jagp.2021.06.006. Epub 2021 Jun 19.
- Results publication: PubMed 28248154Lewis H, Adamson J, Atherton K, Bailey D, Birtwistle J, Bosanquet K, Clare E, Delgadillo J, Ekers D, Foster D, Gabe R, Gascoyne S, Haley L, Hargate R, Hewitt C, Holmes J, Keding A, Lilley-Kelly A, Maya J, McMillan D, Meer S, Meredith J, Mitchell N, Nutbrown S, Overend K, Pasterfield M, Richards D, Spilsbury K, Torgerson D, Traviss-Turner G, Trepel D, Woodhouse R, Ziegler F, Gilbody S. CollAborative care and active surveillance for Screen-Positive EldeRs with subthreshold depression (CASPER): a multicentred randomised controlled trial of clinical effectiveness and cost-effectiveness. Health Technol Assess. 2017 Feb;21(8):1-196. doi: 10.3310/hta21080.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra S Carne, PhD Student principal investigator
Teesside University/ Univeristy of York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Depression, run by Teesside University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PhQ-9 (Patient Health Questionnaire- 9 (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05477758, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.