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The Impact of Pain on Depression Outcomes

NCT05477758 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1522

Last updated 2023-04-14

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University of York

    collaborator OTHER

  • Teesside University

    lead OTHER

Principal Investigators

  • Alexandra S Carne, PhD Student · Teesside University/ Univeristy of York

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05477758 on ClinicalTrials.gov