The Impact of Pain on Depression Outcomes

Teesside University

Status: Active, not recruiting

Conditions: Depression; Pain

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

Study type: Observational

Funder types: Other

Identifiers

NCT05477758

ISRCTN02202951 (Registry Identifier)

ISRCTN45842879 (Registry Identifier)

8838

ISRCTN95270332 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,522 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,522 participants in 3 patient groups

CASPER

Description:

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

Treatment:

Behavioral: Collaborative care

Other: Usual General Practitioner (GP) care

CASPER+

Description:

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

Treatment:

Behavioral: Collaborative care

Other: Usual General Practitioner (GP) care

SHARD

Description:

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

Treatment:

Behavioral: Behavioral Activation Self-Help guide

Other: Usual General Practitioner (GP) care