The Impact of Pain on Depression Outcomes

NCT05477758 | Unknown

• 4 other identifiers: 8838ISRCTN02202951ISRCTN45842879ISRCTN95270332
• Study Type: observational
• Target: 1,522
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pain; Depression

Keywords

Older Adults; Behavioural Activation

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline

Study Arms (3)

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

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

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

Other: Usual General Practitioner (GP) care; Behavioral: Behavioral Activation Self-Help guide

Interventions

Collaborative care BEHAVIORAL

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

Also known as: behavioural activation

CASPER; CASPER+

Usual General Practitioner (GP) care OTHER

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.

CASPER; CASPER+; SHARD

Behavioral Activation Self-Help guide BEHAVIORAL

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

SHARD

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were aged 65 years or older with subthreshold depression (CASPER and SHARD) or case-level depression (CASPER+)

You may qualify if:

• Patients who participated in CASPER, CASPER + or SHARD study

You may not qualify if:

• Anyone who did not consent into one of the three studies above

Sponsors & Collaborators

• Teesside University: lead
• University of York: collaborator

Study Sites (1)

Teesside University

Middlesbrough, TS1 3BX, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 29171379 RESULT

• Gilbody 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.

  PMID: 34266750 RESULT

• Lewis 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.

  PMID: 28248154 RESULT

MeSH Terms

Conditions

Pain; Depression

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Alexandra S Carne, PhD Student

  Teesside University/ Univeristy of York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 28, 2022
• Study Start: September 15, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)