Chronic PainNCT06816082
Internet-based Acceptance Based Psychotherapy As an Adjunct to Chronic Pain Rehabilitation
A study testing Internet delivered acceptance and commitment therapy in people with Chronic Pain, run by Linkoeping University at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Internet delivered acceptance and commitment therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 22 Jan 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Severe cognitive problems, or severe mental illness such as a psychotic episode
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Peter Molander, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Pain and Rehabilitation Clinic
Linköping, Östergötland County, 58758
Nina Bendelin
Peter Molander
About this study
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Internet delivered acceptance and commitment therapy
- Keywords
- chronic pain, acceptance and commitment therapy, internet delivered treatment
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet delivered acceptance and commitment therapyBehavioural
7 week long treatment with therapist asynchronous support in mainly text format. Treatment includes for example mindfulness, psychoeducation, values, and self-compassion
| Study group | Role | What they receive |
|---|---|---|
| Internet delivered acceptance and commitment therapy | Experimental | 7 week long treatment with therapist asynchronous support in mainly text format. Treatment includes for example mindfulness, psychoeducation, values, and self-compassion Receives: Behavioral: Internet delivered acceptance and commitment therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before treatment starts, once in the middle of treatment (3 weeks after start), and after treatment has ended (at 7 weeks post start).
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Post only (7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start22 Jan 2025
- Primary completionJul 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nina Bendelin, Linkoeping University
- Investigators
- Nina Bendelin, PhD, Principal investigator, Region Östergötland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816082
- Sponsor's protocol ID
- 2024-06790-01
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Might interfere with ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Acceptance Based Psychotherapy As an Adjunct to Chronic Pain Rehabilitation
- ClinicalTrials.gov ID
- NCT06816082
- Acronym / sponsor ID
- 2024-06790-01
- Conditions
- Chronic Pain
- Keywords
- chronic pain, acceptance and commitment therapy, internet delivered treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internet delivered acceptance and commitment therapy | Experimental | Behavioral: Internet delivered acceptance and commitment therapy7 week long treatment with therapist asynchronous support in mainly text format. Treatment includes for example mindfulness, psychoeducation, values, and self-compassion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Severe cognitive problems, or severe mental illness such as a psychotic episode
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet delivered acceptance and commitment therapy7 week long treatment with therapist asynchronous support in mainly text format. Treatment includes for example mindfulness, psychoeducation, values, and self-compassion | Behavioural | Internet delivered acceptance and commitment therapy |
Primary outcome
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.
10 secondary outcomes
Quantitative - Brief Pain Inventory
Time frame: Pre and post (7 weeks)
Quantitative - Chronic Pain Acceptance Questionnaire 8
Time frame: pre and post (7 weeks)
Quantitative -Pain Self-Efficacy Questionnaire 8
Time frame: pre and post (7 weeks)
Quantitative - Pain Catastrophizing Scale
Time frame: pre and post (7 weeks)
Quantitative - Numeric rating scale
Time frame: Pre and post (7 weeks)
Quantitative -Patient Global Impression of Change
Time frame: Post only (7 weeks)
Quantitative - Brunnsviken Brief Quality of Life Scale
Time frame: Pre and post (7 weeks)
Quantitative - Patient Health Questionnaire 9
Time frame: Pre and post (7 weeks)
Quantitative - Generalized Anxiety Disorder 7
Time frame: Pre and post (7 weeks)
Quantitative - Negative effects questionnaire
Time frame: Post only (7 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: Undecided. Might interfere with ethical approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Molander, PhD contact
Nina Bendelin, PhD principal investigator
Region Östergötland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet delivered acceptance and commitment therapy in people with Chronic Pain, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nina Bendelin, PhD (+46101030000, nina.bendelin@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.