Internet-based Acceptance Based Psychotherapy As an Adjunct to Chronic Pain Rehabilitation

The goal of this clinical trial is to evaluate how an acceptance based internet-delivered psychological treatment (IACT) tailored to patients with chronic pain is perceived, and if it meets the needs and expectations of those enrolled.

The main question it aims to answer is:

What are the expectations of patients with chronic pain prior to IACT treatment, and how do they experience IACT during and after treatment?

Participants will be offered a 7 week long treatment with therapist support. They will be interviewed before treatment starts, once during treatment, and again after treatment is completed.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Internet delivered acceptance and commitment therapy

Detailed Description

This research project aims to interview adults with chronic pain to explore their expectations before, during, and after receiving internet-based Acceptance and Commitment Therapy (IACT). IACT aims to increase accessibility to psychological treatment by overcoming geographical, economic, social, or physical barriers. The study will investigate how IACT is received and how patient expectations align with their treatment experiences. This is important because previous studies have shown that chronic pain patients' experiences with IACT vary greatly, and there is limited knowledge about their specific needs and expectations regarding internet-based psychological treatment.

Chronic pain is a widespread and challenging condition affecting approximately 20% of the population. Internet-delivered psychological treatments, such as IACT, have emerged in the past 20 years, showing promising results in managing chronic pain. However, research on patient expectations and experiences with IACT remains limited. This qualitative study will use semi-structured interviews to gather data from 10-15 adults with chronic pain. Three interviews will be conducted per participant: before, during, and after IACT treatment. Thematic analysis will be used to analyze the interview transcripts.

The IACT treatment will consist of 7 modules delivered over 7 weeks. The study's findings will hopefully contribute to a better understanding of how expectations and needs influence the treatment process and outcomes for individuals with chronic pain receiving IACT. This knowledge can inform the development and delivery of more effective and patient-centered IACT programs.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nina Bendelin, PhD; Phone Number: +46101030000; Email: nina.bendelin@liu.se
• Study Contact Backup: Name: Peter Molander, PhD; Phone Number: +46101030000

Study Locations

• Sweden
  • Östergötland
    • Linköping, Östergötland, Sweden, 58758
      • Recruiting
      • Pain and Rehabilitation clinic
      • Contact: Nina Bendelin
      • Contact: Peter Molander

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants must be adults with sufficient understanding of Swedish to speak and read, have internet access, and currently be a patient at the Pain and Rehabilitation Clinic in Linköping.

Exclusion Criteria:

• Severe cognitive problems, or severe mental illness such as a psychotic episode

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet delivered acceptance and commitment therapy; 7 week long treatment with therapist asynchronous support in mainly text format. Treatment includes for example mindfulness, psychoeducation, values, and self-compassion	Behavioral: Internet delivered acceptance and commitment therapy; 7 week long treatment with therapist asynchronous support in mainly text format. Treatment includes for example mindfulness, psychoeducation, values, and self-compassion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main outcome - qualitative	Semi-structured interviews with patients experiencing chronic pain will be conducted before, during, and after IACT treatment. The interviews will be analyzed thematically to identify recurring themes related to patients' expectations of IACT treatment, their experiences during the treatment, their perceptions of the treatment, and the extent to which the treatment meets their needs. The main areas that will be explored include, but are not limited to, expectations regarding function, pain perception, and quality of life; experiences of the treatment process; perceived benefits and drawbacks of the treatment; and perceptions of whether the treatment addressed their individual needs.	Before treatment starts, once in the middle of treatment (3 weeks after start), and after treatment has ended (at 7 weeks post start).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative - Brief Pain Inventory	The pain interference part of the Swedish version of the Brief Pain Inventory - Short Form. A higher scores indicate greater severity and interference. Min: 0. Max: 70.	Pre and post (7 weeks)
Quantitative - Chronic Pain Acceptance Questionnaire 8	8 items long acceptance questionnaire with two sub scales. For the Engagement subscale, a higher score indicates more engagement in valued activities. For the pain willingness sub scale, a higher score indicates a greater willingness to experience pain. Min: 0. Max: 48.	pre and post (7 weeks)
Quantitative -Pain Self-Efficacy Questionnaire 8	8 item long questionnaire measuring self efficacy. Higher scores indicate greater levels of confidence in dealing with pain. Min: 0. Max: 48.	pre and post (7 weeks)
Quantitative - Pain Catastrophizing Scale	13 item long questionnaire about pain related catastrophizing with three sub scales. Higher scores indicate a greater degree of pain catastrophizing. Min: 0. Max: 52.	pre and post (7 weeks)
Quantitative - Numeric rating scale	Average pain during the last 24 hours, from 0 to 10. Higher scores indicate more pain.	Pre and post (7 weeks)
Quantitative -Patient Global Impression of Change	Single question with 7 predetermined answers regarding perceived benefit or deterioration. Lower scores indicate deterioration and higher improvement.	Post only (7 weeks)
Quantitative - Brunnsviken Brief Quality of Life Scale	Short quality of life measure. Higher scores indicate greater quality of life. Min: 11. Max: 77.	Pre and post (7 weeks)
Quantitative - Patient Health Questionnaire 9	9 item long depression inventory. Higher scores indicate more depressive symptoms. Min: 0. Max: 27.	Pre and post (7 weeks)
Quantitative - Generalized Anxiety Disorder 7	7 items long anxiety inventory. A higher score means more anxiety. Min: 0. Max: 21.	Pre and post (7 weeks)
Quantitative - Negative effects questionnaire	20 item long questionnaire to measure negative or unwanted effects of treatment. Scoring guide by original authors: The self-report measure consists of three parts. First, respondents endorse specific items in case they have occurred or not during treatment, yes/no (dummy coded as a variable: 1/0). Second, the respondents rate how negatively the negative effect was on four-point Likert-scale, ranging from "Not at all" to "Extremely", 0-4 ("0" being minimum and "4" being maximum). Third, the respondents attribute the negative effect to "The treatment I received" (1) or "Other circumstances" (0) (dummy coded as a variable: 1/0).	Post only (7 weeks)

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Principal Investigator: Nina Bendelin, PhD, Region Östergötland

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: chronic pain; acceptance and commitment therapy; internet delivered treatment
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2024-06790-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Might interfere with ethical approval.

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