iACT for PTSD and Chronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSkane University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
iACT for PTSD and Chronic Pain
BehavioralThe 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 groups
40 Participants
are divided into 2 treatment groupsGroup A: TreatmentExperimental treatment 1 intervention
Group B: WaitlistNo intervention 0 interventions
Trial outcomes
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)
Time frame
Baseline, mid-treatment (3 weeks), mid-treatment (7 weeks), two-week-post treatment, 3 month-follow-up, 12-month follow-up.Secondary outcomes
1
Anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS)
(changes between assessments)
Time frame
Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up.2
Psychological inflexibility as measured by the Psychological Inflexibility in Pain Scale (PIPS)
(changes between assessments)
Time frame
Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up.3
General acceptance as measured by the Swedish Acceptance and Action Questionnaire (SAAQ)
(changes between assessments)
Time frame
Baseline, mid-treatment (3 weeks), mid-treatment (7 weeks), two-week-post treatment, 3 month-follow-up, 12-month follow-up.4
Posttraumatic Cognitions as measured by the Posttraumatic Cognitions Inventory (PTCI)
(changes between assessments)
Time frame
Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov