iACT for PTSD and Chronic Pain : a Development Pilot Series

NCT04306809 | Completed

• 1 other identifier: SkaneU2020
• Study Type: interventional
• Target: 10
• 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. 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.

Conditions

PTSD; Chronic Pain

Keywords

PTSD; Chronic pain

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

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

• Psychological inflexibility as measured by the Psychological Inflexibility in Pain Scale (PIPS)

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

• Acceptance as measured by the Chronic Pain Acceptance Questionnaire-8 (CPAQ-8)

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

• Posttraumatic Cognitions as measured by the Posttraumatic Cognitions Inventory (PTCI)

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

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

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

Study Arms (1)

Treatment

EXPERIMENTAL

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

Behavioral: Internet-delivered ACT for PTSD and chronic pain

Interventions

Internet-delivered ACT for PTSD and chronic pain BEHAVIORAL

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.

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, Sverige, 22241, Sweden

Location

Related Publications (1)

• 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.

  PMID: 38421757 DERIVED

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal Investigator

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: March 13, 2020
• Study Start: August 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: November 1, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)