iACT for PTSD and Chronic Pain

• ClinicalTrials.gov Identifier: NCT05147948
• Recruitment Status: Recruiting
• First Posted: December 7, 2021
• Last Update Posted: December 7, 2021
• Sponsor: Skane University Hospital
• Information provided by (Responsible Party): Sophia Åkerblom, Skane University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ptsd; Chronic Pain	Behavioral: iACT for PTSD and Chronic Pain	Not Applicable

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 : 60 (30+30) 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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomised controlled trial with waitlist control.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Internet-based Acceptance and Commitment Therapy for PTSD and Chronic Pain
• Actual Study Start Date: October 18, 2021
• Estimated Primary Completion Date: October 18, 2024
• Estimated Study Completion Date: October 18, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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) [ Time Frame: Baseline, mid-treatment (3 weeks), mid-treatment (7 weeks), two-week-post treatment, 3 month-follow-up, 12-month follow-up. ]
   (changes between assessments)

Secondary Outcome Measures :

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

Eligibility Criteria

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

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))

Contacts and Locations

Contacts

Contact: Sophia Åkerblom, PhD; 0046707790415; Sophia.akerblom@psy.lu.se

Contact: Sanna Stacke; sanna.stacke@skane.se

Locations

Sweden

Department of Pain Pehabilitation, Skåne University Hospital; Recruiting

Lund, Sweden, 22241

Sponsors and Collaborators

Skane University Hospital

More Information

• Responsible Party: Sophia Åkerblom, Principal investigator, Skane University Hospital
• ClinicalTrials.gov Identifier: NCT05147948
• Other Study ID Numbers: SkaneU2
• First Posted: December 7, 2021
• Last Update Posted: December 7, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sophia Åkerblom, Skane University Hospital:

PTSD; Chronic pain; ACT

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations