PTSDNCT04306809
iACT for PTSD and Chronic Pain : a Development Pilot Series
A study testing Internet-delivered ACT for PTSD and chronic pain in people with PTSD and Chronic Pain, run by Skane University Hospital at 1 site in Sweden.
Trial summary
The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy for PTSD and comorbid chronic pain. First, a pilot study (no randomization; N=10) will be conducted to test the intervention and assessment procedures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD, Chronic Pain
- What is being tested?
- Internet-delivered ACT for PTSD and chronic pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2020to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a CAPS of ≥25
- subjected to single traumatic events
- were able to understand Swedish
- had symptoms of chronic pain that interfered significantly with everyday life
- 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
Show all 9Show fewer
- stable dose of medication
- able to read and write in Swedish
- had access to a smart phone or computer with internet access
Who cannot join
- repeated and extensive traumatic events
- had other 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)
- 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 and a score of 3 to item 9 of the Patient Health Questionnaire 9-item version (PHQ9))
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Pain Pehabilitation, Skåne University Hospital
Lund, Sverige, 22241
About this study
Official title: Internet-delivered ACT for PTSD and Chronic Pain : a Development Pilot Series
The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy for PTSD and comorbid chronic pain. First, a pilot study (no randomization; N=10) will be conducted to test the intervention and assessment procedures. This will be followed by a randomized controlled trial with waitlist control. The participants will go through an active internet-based ACT treatment focused on education about PTSD, value-based exposure for the traumatic memory and 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 3 times during the program and can also contact their psychologist via a message system in the platform and expect answer within 48 hours.
Read the detailed description
Objective: The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy (iACT) for PTSD and comorbid chronic pain.
Sample size: 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 post treatment (2 weeks after treatment) assessments will be conducted by an assessor who is trained to administer the study measures. Self-report measures will also collected at this time, post treatment (2 weeks after treatment) as well as during a 3-month follow up.
Assessment includes:
Pre-and post assessment: Assessors will collect demographic information, self-report measures, and trauma history. During the pre- and post-assessment the Clinician-Administered PTSD Scale for DSM-5 will be administered to establish PTSD whether participants met the DSM-5 criteria for PTSD.
During the pre-assessment the Mini International Neuropsychiatric Interview 5.0 (MINI) will be administered to detect the presence of other comorbid disorders and assess inclusion criteria and rule out exclusion criteria.
Post-treatment exit interview: At the post-assessment, the assigned assessor will ask participants about their satisfaction with and experience of the program, what they found helpful or unhelpful and suggestions for future improvements.
During treatment: During treatment the treatment credibility scale will be administered to assess the patients' perceptions of how credible the treatment is following the introduction of the treatment rationale and the main treatment components (included in the internet program).
Safety parameters: As a mean to monitor safety and progress participants complete two self-report measures within the program (PTSD Checklist for DSM-5 [PCL-5] and Hospital anxiety and depression scale [HADS] twice during the program and the therapist can follow these scores. In addition, participants can report any adverse events during treatment, at post treatment and follow-up assessment.
Data collection: Self-report measures will be mailed to participants
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.
- Conditions
- PTSD, Chronic Pain
- Being tested
- Internet-delivered ACT for PTSD and chronic pain
- Keywords
- PTSD, Chronic pain
- Medical subject headings
- Stress Disorders, Post-Traumatic, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered ACT for PTSD and chronic painBehavioural
The participants will go through an active internet-based ACT treatment focused on education about PTSD, value-based exposure for the traumatic memory and 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 3 times during the program and can also contact their psychologist via a message system in the platform and expect answer within 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Internet delivered Acceptance and Commitment Therapy for PTSD and Chronic Pain, supported by a psychologist Receives: Behavioral: Internet-delivered ACT for PTSD and chronic pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD diagnostic status as measured by the Clinician-Administered PTSD Scale (CAPS)
(changes between assessments) The scale assesses the presence of the DSM-5 PTSD criteria A-J.
Measured: Baseline, two-week-post treatment.
PTSD symptom severity as measured by the the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) and the Life Events Checklist (LEC-5)
(changes between assessments) The scale ranges from 0-80 and higher sores indicate greater severity of PTSD symptoms.
Measured: Baseline, two-week-post treatment, 3 month-follow-up.
Secondary outcomes (11)
Anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS)
(changes between assessments) The subscales range from 0-21 and higher scores corresponds to greater severity of depression/anxiety.
Measured: Baseline, two-week-post treatment, 3 month-follow-up.
Psychological inflexibility as measured by the Psychological Inflexibility in Pain Scale (PIPS)
(changes between assessments) The scale ranges from 12-84 and higher scores corresponds to greater psychological inflexibility.
Measured: Baseline, two-week-post treatment, 3 month-follow-up.
Acceptance as measured by the Chronic Pain Acceptance Questionnaire-8 (CPAQ-8)
(changes between assessments) The scale ranges from 0-48 and higher scores corresponds to greater acceptance.
Measured: Baseline, two-week-post treatment, 3 month-follow-up.
Posttraumatic Cognitions as measured by the Posttraumatic Cognitions Inventory (PTCI)
(changes between assessments) The scale ranges from 33-231 and higher scores corresponds to greater endorsement of trauma-related thoughts and beliefs.
Measured: Baseline, two-week-post treatment, 3 month-follow-up.
Pain interference as measured by the Multidimensional Pain Inventory (MPI)
(changes between assessments) The scales ranges from 0-6 and higher scores corresponds to greater pain interference.
Measured: Baseline, two-week-post treatment, 3 month-follow-up.
Pain intensity as measured by the Numerical Rating Scale (NRPS)
(changes between assessments) The scale ranges from 0-10 and higher scores corresponds to greater pain intensity.
Measured: Baseline, two-week-post treatment, 3 month-follow-up.
Pain catastrophizing as measured by the Pain Catastrophizing Questionnaire (PCS)
(changes between assessments) The scale ranges from 0-52 and higher scores represent greater pain catastrophizing.
Measured: Baseline, two-week-post treatment, 3 month-follow-up.
Perceived health as measured by the RAND-36 Measure of Health-Related Quality of Life (RAND-36)
(changes between assessments) Each subscale is directly transformed into a 0-100 scale where higher scores correspond to greater levels on that specific subscale.
Measured: Baseline, two-week-post treatment, 3 month-follow-up.
Kinesiophobia as measured by the Tampa Scale of Kinesiophobia (Tampa)
(changes between assessments) The scale ranges from 17-68 and higher scores represent greater levels of kinesiophobia.
Measured: Baseline, two-week-post treatment, 3 month-follow-up.
Number of adverse events reported by the participant
Measured: 2-week-post treatment.
Health care utilization, pharmaeconomics, medication use, and return to work as measured by the MiDAS-database of the Swedish Social Insurance Agency, the Swedish Prescribed Drug Register and health-care database of Region Skåne
(changes between assessments)
Measured: Baseline, two-week-post treatment, 3 month-follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 Aug 2020
- Primary completion31 Dec 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sophia Åkerblom, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306809
- Sponsor's protocol ID
- SkaneU2020
- Status last verified
- Oct 2021
- First submitted
- 20 Feb 2020
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akerblom S, Nilsson T, Stacke S, Peppler Jonsson I, Nordin L. Internet-based acceptance and commitment therapy for transdiagnostic treatment of comorbid posttraumatic stress disorder and chronic pain: A development pilot study. Psychol Trauma. 2025 Sep;17(6):1154-1164. doi: 10.1037/tra0001663. Epub 2024 Feb 29.
PubMed 38421757
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered ACT for PTSD and Chronic Pain : a Development Pilot Series
- ClinicalTrials.gov ID
- NCT04306809
- Acronym / sponsor ID
- SkaneU2020
- Conditions
- PTSD, Chronic Pain
- Keywords
- PTSD, Chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 13 Mar 2020 (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 primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy for PTSD and comorbid chronic pain. First, a pilot study (no randomization; N=10) will be conducted to test the intervention and assessment procedures. This will be followed by a randomized controlled trial with waitlist control. The participants will go through an active internet-based ACT treatment focused on education about PTSD, value-based exposure for the traumatic memory and 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 3 times during the program and can also contact their psychologist via a message system in the platform and expect answer within 48 hours.
Detailed description
Objective: The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy (iACT) for PTSD and comorbid chronic pain.
Sample size: 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 post treatment (2 weeks after treatment) assessments will be conducted by an assessor who is trained to administer the study measures. Self-report measures will also collected at this time, post treatment (2 weeks after treatment) as well as during a 3-month follow up.
Assessment includes:
Pre-and post assessment: Assessors will collect demographic information, self-report measures, and trauma history. During the pre- and post-assessment the Clinician-Administered PTSD Scale for DSM-5 will be administered to establish PTSD whether participants met the DSM-5 criteria for PTSD.
During the pre-assessment the Mini International Neuropsychiatric Interview 5.0 (MINI) will be administered to detect the presence of other comorbid disorders and assess inclusion criteria and rule out exclusion criteria.
Post-treatment exit interview: At the post-assessment, the assigned assessor will ask participants about their satisfaction with and experience of the program, what they found helpful or unhelpful and suggestions for future improvements.
During treatment: During treatment the treatment credibility scale will be administered to assess the patients' perceptions of how credible the treatment is following the introduction of the treatment rationale and the main treatment components (included in the internet program).
Safety parameters: As a mean to monitor safety and progress participants complete two self-report measures within the program (PTSD Checklist for DSM-5 [PCL-5] and Hospital anxiety and depression scale [HADS] twice during the program and the therapist can follow these scores. In addition, participants can report any adverse events during treatment, at post treatment and follow-up assessment.
Data collection: Self-report measures will be mailed to participants
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Internet-delivered ACT for PTSD and chronic painInternet delivered Acceptance and Commitment Therapy for PTSD and Chronic Pain, supported by a psychologist |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- a CAPS of ≥25
- subjected to single traumatic events
- were able to understand Swedish
- had symptoms of chronic pain that interfered significantly with everyday life
- were fully examined medically and had received medical treatment if indicated
Key exclusion criteria (7 listed)
- repeated and extensive traumatic events
- had other 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)
- 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;
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 ACT for PTSD and chronic painThe participants will go through an active internet-based ACT treatment focused on education about PTSD, value-based exposure for the traumatic memory and 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 3 times during the program and can also contact their psychologist via a message system in the platform and expect answer within 48 hours. | Behavioural | Treatment |
Primary outcome
PTSD diagnostic status as measured by the Clinician-Administered PTSD Scale (CAPS)
Time frame: Baseline, two-week-post treatment.
(changes between assessments) The scale assesses the presence of the DSM-5 PTSD criteria A-J.
PTSD symptom severity as measured by the the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) and the Life Events Checklist (LEC-5)
Time frame: Baseline, two-week-post treatment, 3 month-follow-up.
(changes between assessments) The scale ranges from 0-80 and higher sores indicate greater severity of PTSD symptoms.
11 secondary outcomes
Anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, two-week-post treatment, 3 month-follow-up.
Psychological inflexibility as measured by the Psychological Inflexibility in Pain Scale (PIPS)
Time frame: Baseline, two-week-post treatment, 3 month-follow-up.
Acceptance as measured by the Chronic Pain Acceptance Questionnaire-8 (CPAQ-8)
Time frame: Baseline, two-week-post treatment, 3 month-follow-up.
Posttraumatic Cognitions as measured by the Posttraumatic Cognitions Inventory (PTCI)
Time frame: Baseline, two-week-post treatment, 3 month-follow-up.
Pain interference as measured by the Multidimensional Pain Inventory (MPI)
Time frame: Baseline, two-week-post treatment, 3 month-follow-up.
Pain intensity as measured by the Numerical Rating Scale (NRPS)
Time frame: Baseline, two-week-post treatment, 3 month-follow-up.
Pain catastrophizing as measured by the Pain Catastrophizing Questionnaire (PCS)
Time frame: Baseline, two-week-post treatment, 3 month-follow-up.
Perceived health as measured by the RAND-36 Measure of Health-Related Quality of Life (RAND-36)
Time frame: Baseline, two-week-post treatment, 3 month-follow-up.
Kinesiophobia as measured by the Tampa Scale of Kinesiophobia (Tampa)
Time frame: Baseline, two-week-post treatment, 3 month-follow-up.
Number of adverse events reported by the participant
Time frame: 2-week-post treatment.
Health care utilization, pharmaeconomics, medication use, and return to work as measured by the MiDAS-database of the Swedish Social Insurance Agency, the Swedish Prescribed Drug Register and health-care database of Region Skåne
Time frame: Baseline, two-week-post treatment, 3 month-follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Derived from this study: PubMed 38421757Akerblom S, Nilsson T, Stacke S, Peppler Jonsson I, Nordin L. Internet-based acceptance and commitment therapy for transdiagnostic treatment of comorbid posttraumatic stress disorder and chronic pain: A development pilot study. Psychol Trauma. 2025 Sep;17(6):1154-1164. doi: 10.1037/tra0001663. Epub 2024 Feb 29.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 ACT for PTSD and chronic pain in people with PTSD and Chronic Pain, run by Skane University Hospital 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 9 inclusion and 7 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: finished, as of the sponsor's last update on 1 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD diagnostic status as measured by the Clinician-Administered PTSD Scale (CAPS) (time frame: Baseline, two-week-post treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04306809, which also lists 1 linked publication.
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 1 Nov 2022.