Guided Internet-delivered Psychological Treatment for Chronic Pain

NCT05071547 | Unknown Phase 2

• 1 other identifier: 2010/186-31
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this feasibility study is to investigate if an addition of an internet-delivered psychological treatment, Acceptance and commitment therapy (IACT), can enhance the effect of an existing evidence-based interdisciplinary rehabilitation program (IRPR) for chronic pain patients enrolled in clinical tertiary care, on pain-related psychological outcomes. The study might contribute to developing internet-delivered treatments suitable for this patient group and also help develop implementation strategies for internet interventions in clinical services. The study is planned to run for 2 years and include 300 patients, of which 150 will be in the intervention group and 150 in the control condition. The overall hypothesis is that the IACT addition will lead to better and more sustained results compared to the IRPR alone. The first sub-hypothesis is that the IACT addition will enhance adherence and uptake during the IRPR. The second sub-hypothesis is that the IACT addition will help patients maintain results after the IRPR has ended.

Conditions

Chronic Pain

Keywords

Internet-delivered Acceptance and Commitment Therapy (IACT); Interdisciplinary pain Rehabilitation Program (IRPR); Aftercare; Combined treatment

Outcome Measures

Primary Outcomes (1)

• Change in pain acceptance (The Chronic Pain Acceptance Questionnaire, CPAQ)

  CPAQ is a measure of pain acceptance with 20 items rated on a 6-point scale ranging from "never true" to "always true" and divided into two subscales: activity engagement and pain willingness. CPAQ has been validated for a Swedish sample and for an internet sample. Studies have shown high test-retest reliability (α=0.72-0.92).

  Week 0 (pre treatment), week 6 (post treatment), week 17 (post aftercare) and at 1 year follow up.

Secondary Outcomes (1)

• Change in psychological inflexibility (Psychological Inflexibility in Pain Scale, PIPS)

  Week 0 (pre treatment), week 6 (post treatment), week 17 (post aftercare) and at 1 year follow up.

Study Arms (2)

Internet-delivered acceptance and commitment therapy addition

EXPERIMENTAL

The IACT addition supplies participants with weekly educational material and additional exercises in line with live IRPR, although enriched with multimedia. Participants will have access to their rehabilitation content via the web-site and can practice in their homes in-between live sessions of IRPR.

Behavioral: Guided internet-delivered acceptance and commitment therapy (ACT)

Interdisciplinary pain rehabilitation program

ACTIVE COMPARATOR

A 6-week long multimodal treatment including approximately 108 hours on site, focusing on return to work. Psychologists, physicians, physiotherapists (PT) and occupational therapists (OT) give synchronized treatments with a CBT/ACT approach.

Other: Interdisciplinary Pain Rehabilitation Program (IPRP)

Interventions

Guided internet-delivered acceptance and commitment therapy (ACT) BEHAVIORAL

ACT builds on cognitive behavioral therapy (CBT), and includes methods for experiential learning and focus on psychological flexibility

Internet-delivered acceptance and commitment therapy addition

Interdisciplinary Pain Rehabilitation Program (IPRP) OTHER

Multimodal treatment where physio therapists, occupational therapists, psychologists and physicians give synchronized treatments to raise physical and psychological function and promote return to work

Interdisciplinary pain rehabilitation program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic pain (ie consistent for 6 months), w/out common comorbid or multimorbid diagnoses
• awaiting start of IPRP after medical and psychiatric assessment
• completion of informed consent and pre-measurement forms

You may not qualify if:

• unable to communicate in writing in Swedish
• lack access to a smart phone, tablet or computer

Sponsors & Collaborators

• Linkoeping University: lead

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Björn Gerdle, PhD

  Pain and Rehabilitation Centre, and Department of Health, Medicine and Caring Sciences, Linköping University, Sweden

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, PhD candidate, Lic. psychologist, Lic. psychotherapist, Msc.

Model Details: Upon acceptance and after informed consent has been obtained, participants are consecutively randomized to one of two study groups.

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: October 8, 2021
• Study Start: November 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: December 31, 2022
• Last Updated: October 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share