The Impact of Pain on Depression Outcomes

April 11, 2023 updated by: Alexandra Carne, Teesside University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / 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 Type

Observational

Enrollment (Anticipated)

1522

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Middlesbrough, United Kingdom, TS1 3BX
        • Teesside University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients were aged 65 years or older with subthreshold depression (CASPER and SHARD) or case-level depression (CASPER+)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CASPER
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
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 Names:
  • behavioural activation
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.
CASPER+
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
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 Names:
  • behavioural activation
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.
SHARD
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PhQ-9 (Patient Health Questionnaire- 9
Time Frame: Baseline
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
PhQ-9 (Patient Health Questionnaire- 9
Time Frame: 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.
4 months
SF-12 (Short Form- 12)
Time Frame: 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.
Baseline
EQ-5D (Euroqual Group)
Time Frame: 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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teesside University

Collaborators

University of York

Investigators

  • Principal Investigator: Alexandra S Carne, PhD Student, Teesside University/ Univeristy of York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2022

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

July 12, 2022

First Submitted That Met QC Criteria

July 25, 2022

First Posted (Actual)

July 28, 2022

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8838
  • ISRCTN02202951 (Registry Identifier: ISRCTN registry)
  • ISRCTN45842879 (Registry Identifier: ISRCTN registry)
  • ISRCTN95270332 (Registry Identifier: ISRCTN registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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