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NCT Number: NCT07426367

Internet-Delivered ACT Targeting Emotional Distress and Chronic Pain

The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy for emotional distress and comorbid chronic pain. A pilot study ( N=5-10) will be conducted to test the intervention and assessment procedures. The participants will go through an active internet-based ACT treatment focused on education about emotional distress and pain, as well as behavior change through exercises targeting the processes mindfulness, cognitive defusion and acceptance. The treatment is delivered on a safe internet platform. Participants have planned telephone contact with their assigned psychologist 2 times during the program and can also contact their psychologist via a message system in the platform and expect answer within 48 hours.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Objective The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy (iACT)for emotional distress and chonirc pain.

Sample size 5-10 participants.

Trial design All participants are offered treatment. Participants are recruited from the Pain Rehabilitation Unit at Skåne University Hospital. The unit is a government supported, regional specialist center focused on assessment and treatment of chronic pain and related disability.

Assessments Baseline and posttreatment (2 weeks after treatment) assessments will be conducted. Self-report measures will also be collected at baseline, post-treatment as well as during a 3-month follow up.

Assessment includes:Pre-and post assessment Assessors collected demographic information and self-report measures. During the pre-assessment the Mini International Neuropsychiatric Interview 5.0 (MINI) was administered to detect the presence of other comorbid disorders and assess inclusion criteria and rule out exclusion criteria.

During treatment During treatment the treatment credibility scale will be administered to assess the patients' perceptions of how credible the treatment was following the introduction of the treatment rationale and the main treatment components (included in the internet program).

Safety parameters: Participants can report any adverse events during treatment, at posttreatment and follow-up assessment. Partcipants will be monitored daily (see below).

Post-treatment exit interview At the post-assessment, the assigned assessor asked participants about their satisfaction with and experience of the program, what they found helpful or unhelpful and suggestions for future improvements.

Measures will be taken at baseline, 2-weeks, 3 months follow-up. Self-report measures will be mailed to participants

We also intend to conduct a single-case design with daily data collection during a baseline phase (A) and an intervention phase (B). The treatment intervention spans 8 weeks.

For the daily data collection, we will again use a shortened set of measures comprising approximately 10 items focusing on psychological flexibility, pain intensity, and pain interference. Data will be collected via a digital platform, with secure handling of any personal data.

Main statistical analysis Between-group estimates on outcome will be conducted using repeated measurements. The analyses will be conducted using intention to treat principles and post hoc comparisons. We will also conduct randomization test for the A/B single case data collection.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

emotional distress characterized by clinically significant symptoms of anxiety or depression age between 18-65 years were fully examined medically and had received medical treatment if indicated were able to be an active part of the rehabilitation process, regain functioning in different life areas and participate in treatment interventions for approximately 5 hours every week stable dose of medication able to read and write in Swedish had access to a smart phone or computer with internet access

Exclusion criteria

had acute or severe psychiatric disorders or symptoms that warranted designation as the primary disorder (ongoing substance dependence, untreated bipolar disorder, OCD, psychotic symptoms, severe depression, PTSD) were actively abusing analgesic medications (including narcotics), alcohol or other drugs had great difficulty to harbour and handle strong emotions that could lead to emotional outbursts or self-harming behavior had health risks due to medical reasons; had social or economic difficulties or lack of social support that hindered behavior change current severe suicidal ideation that warranted immediate intervention (indicated by the MINI)

Treatment and study plan

ACT

Behavioral

Behavioral: Acceptance and commitment therapy The participants will go through an active internet-based ACT treatment focused on education about emotional distress and chronic pain, value-based exposure for avoided situations, and behavior change through exercises targeting the processes mindfulness, cognitive defusion and acceptance. The treatment is delivered on a safe internet platform. Participants have planned telephone contact with their assigned psychologist 2 times during the program and can also contact their psychologist via a message system in the platform and expect answer within 48 hours.

Primary outcomes

  1. Pain interference

    Time frame: Baseline, two-week-post treatment, 3 month-follow- up

    as measured by the Multidimensional Pain Inventory (MPI). Changes between assessments) Min= 0; Max= 6. Higher scores indicate worse interference.

Secondary outcomes

  1. Psychological inflexibility

    Time frame: [Time Frame: Baseline, two-week-post treatment, 3 month-follow- up

    as measured by the Psychological Inflexibility in Pain Scale (PIPS) (changes between assessments) Min=0; Max= 52. Higher scores indicate worse inflexibility

  2. Anxiety and depression

    Time frame: Baseline, two-week-post treatment, 3 month-follow- up

    as measured by the Hospital Anxiety and Depression Scale (HADS) (changes between assessments) Min= 0; Max= 21. Higher scores indicate worse depression/anxiety.

  3. Pain intensity

    Time frame: Baseline, two-week-post treatment, 3 month-follow- up

    as measured by the Numerical Rating Scale (NRPS) (changes between assessments) Min= 0; Max= 10. Higher scores indicate worse pain intensity.

  4. Pain catastrophizing

    Time frame: Baseline, two-week-post treatment, 3 month-follow- up

    as measured by the Pain Catastrophizing Questionnaire (PCS) (changes between assessments) Min= 0; Max= 52. Higher scores indicate worse pain catastrophizing

  5. Perceived health

    Time frame: Baseline, two-week-post treatment, 3 month-follow- up

    as measured by the RAND-36 Measure of Health-Related Quality of Life (RAND-36) (changes between assessments) Min= 0; Max= 100. Lower scores indicate worse perceived health

  6. Kinesiophobia

    Time frame: Baseline, two-week-post treatment, 3 month-follow- up

    as measured by the Tampa Scale of Kinesiophobia (Tampa) (changes between assessments) Min= 17; Max= 68. Higher scores indicate worse kinesiophobia

Study contacts

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

Sophia Åkerblom, Associate professor

CONTACT

[email protected]

004646172610

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Registry information

Important dates

Study start
2027
Primary completion
2027
Study completion
2028
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

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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