NCT05147948

iACT for PTSD and Chronic Pain

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Skane University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 using a randomized controlled trial with waitlist control.

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.

Conditions

• Ptsd
• Chronic Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-18
• Primary completion: 2026-10-18
• Completion: 2027-12-18
• First posted: 2021-12-07
• Last updated: 2026-02-19

Locations

1 site across 1 country: Sweden