iACT for PTSD and Chronic Pain

Internet-based Acceptance and Commitment Therapy for PTSD and Chronic Pain

The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy for PTSD and comorbid chronic pain using a randomized controlled trial with waitlist control.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Ptsd
• Intervention / Treatment: Behavioral: iACT for PTSD and Chronic Pain

Detailed Description

Objective: The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy for PTSD and comorbid chronic pain.

Sample size : 40 (20+20) participants in total.

Trial design: A randomised trial where participants are allocated to either IACT for PTSD/Pain or control group (wait-list 12 weeks). All participants will eventually receive treatment, since participants randomized to the control group are subsequently offered identical 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 be collected at this time, post treatment (2 weeks after treatment) as well as during a 3-month and a 12-month follow up.

Assessment includes:

Pre-and post assessment: Assessors will collect demographic information, self-report measures, and trauma history.

During the pre-assessment the Clinician-Administered PTSD Scale for DSM-5 will be administered to establish that the participants meet the DSM-5 criteria for PTSD. The Mini International Neuropsychiatric Interview 7.0 (MINI) will also 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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophia Åkerblom, PhD; Phone Number: 0046707790415; Email: Sophia.akerblom@psy.lu.se
• Study Contact Backup: Name: Sanna Stacke; Email: sanna.stacke@skane.se

Study Locations

• Sweden
  • Lund, Sweden, 22241
    • Recruiting
    • Department of Pain Pehabilitation, Skåne University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• stable dose of medication
• able to read and write in Swedish
• had access to a smart phone or computer with internet access

Exclusion Criteria:

• 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))

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Internet delivered Acceptance and Commitment Therapy for PTSD and Chronic Pain, supported by a psychologist	Behavioral: iACT for PTSD and Chronic Pain; The participants will go through internet-based Acceptance and Commitment Therapy which mainly involves: 1) Exercises focused on developing acceptance, defusion, and mindfulness skills; 2) Identification of personal values as well as valued steps and feared situations to approach during the program 3) Written exposure exercises focusing on the traumatic memory adapted from Written exposure therapy (WET) using an ACT-based framework. 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.
No Intervention: Waitlist; Waitlist for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline, mid-treatment (3 weeks), mid-treatment (7 weeks), two-week-post treatment, 3 month-follow-up, 12-month follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events reported by the participant		2-week-post treatment.
Anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS)	(changes between assessments)	Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up.
Psychological inflexibility as measured by the Psychological Inflexibility in Pain Scale (PIPS)	(changes between assessments)	Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up.
General acceptance as measured by the Swedish Acceptance and Action Questionnaire (SAAQ)	(changes between assessments)	Baseline, mid-treatment (3 weeks), mid-treatment (7 weeks), two-week-post treatment, 3 month-follow-up, 12-month follow-up.
Posttraumatic Cognitions as measured by the Posttraumatic Cognitions Inventory (PTCI)	(changes between assessments)	Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up.
Pain interference as measured by the Multidimensional Pain Inventory (MPI)	(changes between assessments)	Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up.
Pain intensity as measured by the Numerical Rating Scale (NRPS)	(changes between assessments)	Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up.
Pain catastrophizing as measured by the Pain Catastrophizing Questionnaire (PCS)	(changes between assessments)	Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up.
Perceived health as measured by the RAND-36 Measure of Health-Related Quality of Life (RAND-36)	(changes between assessments)	Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up.
Kinesiophobia as measured by the Tampa Scale of Kinesiophobia (Tampa)	(changes between assessments)	Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up.
Pain-acceptance as measured by the Chronic Pain Acceptance Questionnaire-8	(changes between assessments)	Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up.
Health care utilization from health-care database of Region Skåne	(changes between assessments)	Baseline, two-week-post treatment, 12-month follow-up.
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)	Baseline, two-week-post treatment, 12-month follow-up.
Medication use from the Swedish Prescribed Drug Register	(changes between assessments)	Baseline, two-week-post treatment,12-month follow-up.

Collaborators and Investigators

• Sponsor: Skane University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Estimated): October 18, 2026
• Study Completion (Estimated): December 18, 2027

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; Chronic pain; ACT
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Pain; Neurologic Manifestations; Mental Disorders; Stress Disorders, Traumatic; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: SkaneU2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No