Cross-Sectional Associations Among Symptoms of Pain, Irritability, and Depression and How These Symptoms Relate to Social Functioning and Quality of Life: Findings From the EMBARC and STRIDE Studies and the VitalSign6 Project

Abstract

Objective: The aim of this report was to evaluate the psychometric properties of the Pain Frequency, Intensity, and Burden Scale (P-FIBS), a brief measure of pain, as well as the association of pain with irritability and depression and how these symptoms relate to functional impairments.

Methods: Participants of 2 randomized controlled trials (Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care [EMBARC; n = 251 with DSM-IV diagnosis of major depressive disorder; study duration: August 2011-December 2015] and STimulant Reduction Intervention Using Dosed Exercise [STRIDE; n = 302 with DSM-IV diagnosis of stimulant abuse or dependence; study-duration: July 2010-February 2013]) and treatment-seeking patients in primary care clinics from an ongoing quality-improvement project (VitalSign6; n = 4,370; project duration: August 2014-July 2019) were included. Psychometric properties of the P-FIBS were evaluated with confirmatory factor and item response theory analyses in EMBARC and VitalSign6. The approach of Baron and Kenny was used to assess whether irritability accounted for the effect of pain on depression.

Results: Cronbach α (0.84-0.89) and model fits for single-factor structure of P-FIBS were acceptable. Pain was positively correlated with irritability (r = 0.22-0.29) and depression (r = 0.10-0.33). Irritability accounted for 40.7%-65.5% of the effect of pain on depression. Higher irritability and depression were associated with poorer social functioning, quality of life, and productivity in work- and non-work-related activities. Pain was associated with non-work-related activity impairments even after controlling for irritability and depression.

Conclusions: The P-FIBS is a brief and reliable measure of pain. Irritability is associated with pain and accounts for a large proportion of the effect of pain on depression. Symptoms of pain, irritability, and depression are associated with functional impairments.

Trial registration: ClinicalTrials.gov identifiers: NCT01407094 (EMBARC), NCT01141608 (STRIDE).

Conflict of interest statement

Potential conflicts of interest: Dr Jha has received contract research grants from Acadia and Janssen Research & Development and honoraria for CME presentations from North American Center for Continuing Medical Education and Global Medical Education. Dr Schatzberg has consulted to Axsome, Schwabe, NeuraWell, Compass, EMI,Tris, Signant, Otsuka, Delpor, Vorso, Epiodyne, Myriad Genetics, Owl Analytics, and Jazz; he has equity in Corcept, Epiodyne, Delpor, Vorso, NeuraWell, X-Hale, and Owl Analytics. Dr Trivedi has served as an adviser or consultant for Abbott Laboratories, Abdi Ibrahim, Akzo (Organon Pharmaceuticals), Alkermes, AstraZeneca, Axon Advisors, Bristol-Myers Squibb, Cephalon, Cerecor, CME Institute of Physicians, Concert Pharmaceuticals, Eli Lilly, Evotec, Fabre, Forest, GlaxoSmithKline, Janssen Global Services, Janssen Pharmaceutical Products, Johnson & Johnson PRD, Libby, Lundbeck, Meade Johnson, MedAvante, Medtronic, Merck, Mitsubishi Tanabe Pharma Development America, Naurex, Neuronetics, Otsuka, Pamlab, Parke-Davis, Pfizer, PgxHealth, Phoenix Marketing Solutions, Rexahn, Ridge Diagnostics, Roche Products, Sepracor, Shire Development, Sierra, SK Life and Science, Sunovion, Takeda, Tal Medical/Puretech Venture, Targacept, Transcept, VantagePoint, Vivus, and Wyeth-Ayerst; he has received grants or research support from the Agency for Healthcare Research and Quality, Cyberonics, NARSAD, National Institute on Drug Abuse (NIDA), and National Institute of Mental Health (NIMH). Drs Minhajuddin and Chin Fatt and Ms Mayes have no conflicts to report.

© Copyright 2021 Physicians Postgraduate Press, Inc.

Figures

Figure 1.. Irritability Accounts for the Effect of Pain on Depression in (A) the EMBARC Study, (B) the STRIDE Study, and (C) the VitalSign6 Projecta

aPain, measured with the P-FIBS, was the independent variable of interest, and irritability, measured with the CAST-IRR, was the moderating variable in all 3 analyses. Depression, the outcome variable, was measured with the QIDS-SR in Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care for Depression (EMBARC) study, with the QIDS-C clinician version in the STRIDE study, and PHQ-9 in the VitalSign6 project. Abbreviations: CAST-IRR = 5-item irritability domain of the Concise Associated Symptom Tracking scale; EMBARC = Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care for Depression; P-FIBS = Pain Frequency, Intensity, and Burden Scale; PHQ-9 = 9-item Patient Health Questionnaire; QIDS-C = Quick Inventory of Depressive Symptomatology Clinician-Rated; QIDS-SR = QIDS Self-Report; STRIDE = STimulant Reduction Intervention Using Dosed Exercise.

Figure 2.. Association Between Symptoms of Pain, Irritability and Depression and Measures of (A) Social Functioning, (B) Quality of Life, (C) Non–Work-Related Activity Impairment, and (D) Work Productivity Impairmenta

aThis figure presents the β estimates and their 95% CIs (represented by the error bars) of the association between symptom measures (pain, irritability, and depression) and measures of social functioning (measured with the 24-item Short Version of the SAS-SR) in the EMBARC study, quality of life (measured with the 14-item short form version of the Q-LES-Q) in the STRIDE study, and productivity in work- and non–work-related activities (measured with the WPAI) in the VitalSign6 project. Abbreviations: EMBARC = Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care for Depression; Q-LES-Q = Quality of Life Enjoyment and Satisfaction Questionnaire, SAS-SR = Social Adjustment Scale Self-Report, STRIDE = STimulant Reduction Intervention Using Dosed Exercise, WPAI = Work Productivity and Activity Impairment scale.