The Impact of Pain on Depression Outcomes

Active, not recruiting

• Conditions: Pain; Depression
• Interventions: Other: Usual General Practitioner (GP) care; Behavioral: Collaborative care; Behavioral: Behavioral Activation Self-Help guide

• Registration Number: NCT05477758
• Lead Sponsor: Teesside University

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.

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.

Study Timeline

• Study First Submitted: 2022-07-12
• Study First Submitted QC: 2022-07-25
• Study First Posted: 2022-07-28
• Study Start: 2022-09-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-14
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1522

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SHARD	Usual General Practitioner (GP) care	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
CASPER	Collaborative care	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
CASPER	Usual General Practitioner (GP) care	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
CASPER+	Collaborative care	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
CASPER+	Usual General Practitioner (GP) care	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
SHARD	Behavioral Activation Self-Help guide	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

Primary Outcome Measures

Name	Time	Method
EQ-5D (Euroqual Group)	Baseline	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.
PhQ-9 (Patient Health Questionnaire- 9	4 months	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.
SF-12 (Short Form- 12)	Baseline	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.

Trial Locations

Locations (1)

Teesside University; 🇬🇧 Middlesbrough, United Kingdom