The INternet ThERapy for deprESsion Trial (INTEREST): protocol for a patient-preference, randomised controlled feasibility trial comparing iACT, iCBT and attention control among individuals with comorbid chronic pain and depression

Louise V Bell; Peter Cornish; David Flusk; Sheila N Garland; Joshua A Rash

doi:10.1136/bmjopen-2019-033350

The INternet ThERapy for deprESsion Trial (INTEREST): protocol for a patient-preference, randomised controlled feasibility trial comparing iACT, iCBT and attention control among individuals with comorbid chronic pain and depression

BMJ Open. 2020 Feb 28;10(2):e033350. doi: 10.1136/bmjopen-2019-033350.

Authors

Louise V Bell¹, Peter Cornish², David Flusk³, Sheila N Garland⁴, Joshua A Rash⁵

Affiliations

¹ Psychology, Memorial University of Newfoundland, St. John's, Newfoundland, Canada.
² Student Wellness & Counselling Centre, Memorial University of Newfoundland, St. John's, Newfoundland, Canada.
³ Anesthesia, Memorial University of Newfoundland, St. John's, Newfoundland, Canada.
⁴ Departments of Psychology and Oncology, Memorial University of Newfoundland, St. John's, Newfoundland, Canada.
⁵ Psychology, Memorial University of Newfoundland, St. John's, Newfoundland, Canada jarash@mun.ca.

Abstract

Introduction: Approximately one-third of adults with chronic pain also report clinically relevant levels of depression. Internet-delivered psychological therapies such as Cognitive Behavioural Therapy (iCBT) and Acceptance and Commitment Therapy (iACT) have been developed to overcome barriers of access to services and ensure the timely delivery of care. The objective of this trial is to collect data on feasibility, acceptability and range of probable effect sizes for iCBT and iACT interventions tailored towards the treatment of depression and chronic pain using a randomised controlled patient-preference design.

Methods and analysis: Community dwelling adults with chronic non-cancer pain (CNCP) and major depression will be recruited from pain clinics and primary care providers in Newfoundland and Labrador, Canada. The study is a randomised controlled patient-preference trial. Eligible patients will be randomly assigned to a 'preference' or 'no-preference' arm during the first step of randomisation and to intervention or control in the second step of randomisation. Two interventions (ie, iCBT or iACT) will be evaluated relative to attention control. iCBT and iACT involve the completion of 7-weekly online modules augmented with one session of motivational enhancement and weekly therapy sessions. Primary outcomes include (1) feasibility and acceptability parameters and (2) change in symptoms of depression. Secondary outcomes include pain, physical function, emotional function and quality of life. We will recruit 60 participants and examine the range of effect sizes obtained from the trial but will not conduct significance testing as per recommendations for behavioural trial development.

Ethics and dissemination: Ethics was approved by the provincial Health Research Ethics Board. Dissemination of results will be published in a peer-reviewed academic journal and presented at scientific conferences.

Trial registration number: NCT04009135.

Keywords: chronic pain; depression; internet therapies; patient-preference trial.

Publication types

Clinical Trial Protocol
Comparative Study
Research Support, Non-U.S. Gov't

MeSH terms

Acceptance and Commitment Therapy*
Adult
Attention*
Chronic Pain* / therapy
Cognitive Behavioral Therapy*
Depression* / therapy
Feasibility Studies
Humans
Internet
Newfoundland and Labrador
Patient Preference*
Quality of Life
Randomized Controlled Trials as Topic
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT04009135