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NCT Number: NCT06816082

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pain and Rehabilitation Clinic

Linköping, Östergötland County, 58758, Sweden

Location status: Recruiting

Location contact

Nina Bendelin

CONTACT

Peter Molander

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet delivered acceptance and commitment therapy

Behavioral

7 week long treatment with therapist asynchronous support in mainly text format. Treatment includes for example mindfulness, psychoeducation, values, and self-compassion

Primary outcomes

  1. Main outcome - qualitative

    Time frame: Before treatment starts, once in the middle of treatment (3 weeks after start), and after treatment has ended (at 7 weeks post start).

    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.

Secondary outcomes

  1. Quantitative - Brief Pain Inventory

    Time frame: Pre and post (7 weeks)

    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.

  2. Quantitative - Chronic Pain Acceptance Questionnaire 8

    Time frame: pre and post (7 weeks)

    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.

  3. Quantitative -Pain Self-Efficacy Questionnaire 8

    Time frame: pre and post (7 weeks)

    8 item long questionnaire measuring self efficacy. Higher scores indicate greater levels of confidence in dealing with pain. Min: 0. Max: 48.

  4. Quantitative - Pain Catastrophizing Scale

    Time frame: pre and post (7 weeks)

    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.

  5. Quantitative - Numeric rating scale

    Time frame: Pre and post (7 weeks)

    Average pain during the last 24 hours, from 0 to 10. Higher scores indicate more pain.

  6. Quantitative -Patient Global Impression of Change

    Time frame: Post only (7 weeks)

    Single question with 7 predetermined answers regarding perceived benefit or deterioration. Lower scores indicate deterioration and higher improvement.

  7. Quantitative - Brunnsviken Brief Quality of Life Scale

    Time frame: Pre and post (7 weeks)

    Short quality of life measure. Higher scores indicate greater quality of life. Min: 11. Max: 77.

  8. Quantitative - Patient Health Questionnaire 9

    Time frame: Pre and post (7 weeks)

    9 item long depression inventory. Higher scores indicate more depressive symptoms. Min: 0. Max: 27.

  9. Quantitative - Generalized Anxiety Disorder 7

    Time frame: Pre and post (7 weeks)

    7 items long anxiety inventory. A higher score means more anxiety. Min: 0. Max: 21.

  10. Quantitative - Negative effects questionnaire

    Time frame: Post only (7 weeks)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Nina Bendelin, PhD

CONTACT

[email protected]

+46101030000

Peter Molander, PhD

CONTACT

+46101030000

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2025
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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