NCT05477758

The Impact of Pain on Depression Outcomes

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,522 (estimated)
• Sponsor: Teesside University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-09-15
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2022-07-28
• Last updated: 2023-04-14

Locations

1 site across 1 country: United Kingdom