iACT for PTSD and Chronic Pain : a Development Pilot Series

NCT ID: NCT04306809

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2022-03-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

Internet-delivered ACT for PTSD and chronic pain

Intervention Type: 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.

Interventions

Internet-delivered ACT for PTSD and chronic pain

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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))

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Skane University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sophia Åkerblom

Prinicpal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Pain Pehabilitation, Skåne University Hospital

Lund, Sverige, Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 38421757 (View on PubMed)

Other Identifiers

SkaneU2020

Identifier Type: -

Identifier Source: org_study_id