Internet-delivered ACT for Chronic Pain

NCT03105908 | Completed

• 1 other identifier: 2015/1638-31/2
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of the present study is to evaluate an internet-delivered Acceptance and Commitment therapy treatment (iACT) for patients with chronic pain. More specifically, the study will evaluate if 1) iACT is effective in improving functioning and quality of life in comparison to a waitlist condition, 2) if iACT is cost-effective, 3) factors that influence treatment outcome (i.e. predictors, moderators or characteristics of treatment responders), 4) if psychological variables mediates the effects of treatment on outcome, and 5) if subgroups of patients varies in change processes (i.e. moderated mediation). The main hypothesis is that iACT will improve functioning and quality of life.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Pain Interference Index (changes between assessments)

  Self rated measure of daily functioning related to pain

  Baseline, 10 weekly ratings, post (10 weeks), follow ups three, six and twelve months post treatment

Secondary Outcomes (10)

• The Valuing Questionnaire (changes)

  Baseline, mid (4 weeks), post (10 weeks), follow ups three, six and twelve months post treatment

• Psychological Inflexibility in Pain Scale (changes)

  Baseline, 10 weekly ratings, post (10 weeks), follow ups three, six and twelve months post treatment

• Patient Health Questionnaire 9 (changes)

  Baseline, post (10 weeks), follow ups three, six and twelve months post treatment

• European Quality of Life Five Dimensions Questionnaire (changes)

  Baseline, post (10 weeks), follow ups three, six and twelve months post treatment

• Insomnia Severity Index (changes)

  Baseline, post (10 weeks), follow ups three, six and twelve months post treatment

Study Arms (2)

Treatment

OTHER

Internet delivered Acceptance and Commitment therapy, supported by a psychologist/psychology student under supervision.

Behavioral: Internet delivered Acceptance and Commitment therapy

Waiting list control condition

OTHER

Participants receive no treatment for ten weeks, i.e. waiting list condition. Following post-assessment, the control condition receive unguided iACT (i.e. the same content and structure as iACT but without systematic therapist communication).

Behavioral: Waiting list control condition

Interventions

Internet delivered Acceptance and Commitment therapy BEHAVIORAL

The main component in the treatment is exposure to symptoms and feared situations. The iACT program is adapted from the evidence based face-to-face treatment at the Behavioral Medicine unit at Karolinska University Hospital. The iACT program has a different structure but is equal in content to face-to-face treatment, and is to be completed within ten weeks. Participants receive texts, audio files, movies and exercises and have online contact with their psychologist via an internet platform or a smart phone application. The treatment aims to encourage valued behaviors in the presence of inner discomfort.

Also known as: iACT

Treatment

Waiting list control condition BEHAVIORAL

After a ten week wait list period, the control condition receive same treatment as the intervention group, but without therapist support.

Waiting list control condition

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a pain duration of ≥ 6 months;
• are able to communicate in Swedish
• have access to computer and internet in their home environment.
• have access to a cell phone with the possibility of receiving text messages
• no planned changes in medication use, or any other changes in interventions for their pain planned

You may not qualify if:

• injury or illness that require immediate assessment or different treatment, or that is expected to progress significantly during the next 6 months
• unstable medication (planned changes in medication during next 4 months)
• previous ACT or CBT treatment during the past 3 months
• severe psychiatric co-morbidity (e.g. high risk of suicide) as assessed by the psychologist in a semi-structured interview

Sponsors & Collaborators

• Rikard Wicksell: lead
• AFA Insurance: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, Stockholm County, 171 77, Sweden

Location

Related Publications (1)

• Gentili C, Zetterqvist V, Rickardsson J, Holmstrom L, Ljotsson B, Wicksell R. Examining predictors of treatment effect in digital Acceptance and Commitment Therapy for chronic pain. Cogn Behav Ther. 2023 Jul;52(4):380-396. doi: 10.1080/16506073.2023.2191826. Epub 2023 Mar 27.

  PMID: 36971108 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Rikard Wicksell, PhD, MSc

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Functional Area Medical Psychology, Karolinska Univ Hospital, assoc professor and head of research group Behavior Medcine, Karolinska Institutet

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: April 10, 2017
• Study Start: March 16, 2017
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: January 3, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)