iACT for PTSD and Chronic Pain

NCT05147948 | Recruiting

• 1 other identifier: SkaneU2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ptsd; Chronic Pain

Keywords

PTSD; Chronic pain; ACT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS)

  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)

  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)

  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)

  Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up.

• Pain interference as measured by the Multidimensional Pain Inventory (MPI)

  Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up.

Study Arms (2)

Treatment

EXPERIMENTAL

Internet delivered Acceptance and Commitment Therapy for PTSD and Chronic Pain, supported by a psychologist

Behavioral: iACT for PTSD and Chronic Pain

Waitlist

NO INTERVENTION

Waitlist for 12 weeks.

Interventions

iACT for PTSD and Chronic Pain BEHAVIORAL

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.

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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))

Sponsors & Collaborators

• Skane University Hospital: lead

Study Sites (1)

Department of Pain Pehabilitation, Skåne University Hospital

Lund, 22241, Sweden

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Chronic Pain

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sophia Åkerblom, PhD

CONTACT

0046707790415; Sophia.akerblom@psy.lu.se

Sanna Stacke

CONTACT

sanna.stacke@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomised controlled trial with waitlist control.

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: December 7, 2021
• Study Start: October 18, 2021
• Primary Completion (Estimated): October 18, 2026
• Study Completion (Estimated): December 18, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)