The Impact of Pain on Depression Outcomes

Depression Clinical Trial

Official title:

The Impact of Pain on Depression Outcomes of Older Adults in Behavioural Activation: An Exploratory Secondary Data Analysis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05477758
• Other study ID #: 8838
• Secondary ID: ISRCTN02202951IS
• Status: Active, not recruiting
• Start date: September 15, 2022
• Est. completion date: March 2025

Study information

• Verified date: April 2023
• Source: Teesside University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1522
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Pain

Intervention

Behavioral:
• Collaborative care
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

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

Locations

Country	Name	City	State
United Kingdom	Teesside University	Middlesbrough

Sponsors (2)

Lead Sponsor	Collaborator
Teesside University	University of York

Country where clinical trial is conducted

United Kingdom, 

References & 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, — View Citation

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 Geriat — View Citation

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, Nutbro — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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