- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04306809
iACT for PTSD and Chronic Pain : a Development Pilot Series
Internet-delivered ACT for PTSD and Chronic Pain : a Development Pilot Series
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sverige
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Lund, Sverige, Sweden, 22241
- Department of Pain Pehabilitation, Skåne University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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))
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
Internet delivered Acceptance and Commitment Therapy for PTSD and Chronic Pain, supported by a psychologist
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PTSD diagnostic status as measured by the Clinician-Administered PTSD Scale (CAPS)
Time Frame: Baseline, two-week-post treatment.
|
(changes between assessments) The scale assesses the presence of the DSM-5 PTSD criteria A-J.
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Baseline, two-week-post treatment.
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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, two-week-post treatment, 3 month-follow-up.
|
(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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline, two-week-post treatment, 3 month-follow-up.
|
(changes between assessments) The subscales range from 0-21 and higher scores corresponds to greater severity of depression/anxiety.
|
Baseline, two-week-post treatment, 3 month-follow-up.
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Psychological inflexibility as measured by the Psychological Inflexibility in Pain Scale (PIPS)
Time Frame: Baseline, two-week-post treatment, 3 month-follow-up.
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(changes between assessments) The scale ranges from 12-84 and higher scores corresponds to greater psychological inflexibility.
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Baseline, two-week-post treatment, 3 month-follow-up.
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Acceptance as measured by the Chronic Pain Acceptance Questionnaire-8 (CPAQ-8)
Time Frame: Baseline, two-week-post treatment, 3 month-follow-up.
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(changes between assessments) The scale ranges from 0-48 and higher scores corresponds to greater acceptance.
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Baseline, two-week-post treatment, 3 month-follow-up.
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Posttraumatic Cognitions as measured by the Posttraumatic Cognitions Inventory (PTCI)
Time Frame: Baseline, two-week-post treatment, 3 month-follow-up.
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(changes between assessments) The scale ranges from 33-231 and higher scores corresponds to greater endorsement of trauma-related thoughts and beliefs.
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Baseline, two-week-post treatment, 3 month-follow-up.
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Pain interference as measured by the Multidimensional Pain Inventory (MPI)
Time Frame: Baseline, two-week-post treatment, 3 month-follow-up.
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(changes between assessments) The scales ranges from 0-6 and higher scores corresponds to greater pain interference.
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Baseline, two-week-post treatment, 3 month-follow-up.
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Pain intensity as measured by the Numerical Rating Scale (NRPS)
Time Frame: Baseline, two-week-post treatment, 3 month-follow-up.
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(changes between assessments) The scale ranges from 0-10 and higher scores corresponds to greater pain intensity.
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Baseline, two-week-post treatment, 3 month-follow-up.
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Pain catastrophizing as measured by the Pain Catastrophizing Questionnaire (PCS)
Time Frame: Baseline, two-week-post treatment, 3 month-follow-up.
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(changes between assessments) The scale ranges from 0-52 and higher scores represent greater pain catastrophizing.
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Baseline, two-week-post treatment, 3 month-follow-up.
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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.
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(changes between assessments) Each subscale is directly transformed into a 0-100 scale where higher scores correspond to greater levels on that specific subscale.
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Baseline, two-week-post treatment, 3 month-follow-up.
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Kinesiophobia as measured by the Tampa Scale of Kinesiophobia (Tampa)
Time Frame: Baseline, two-week-post treatment, 3 month-follow-up.
|
(changes between assessments) The scale ranges from 17-68 and higher scores represent greater levels of kinesiophobia.
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Baseline, two-week-post treatment, 3 month-follow-up.
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Number of adverse events reported by the participant
Time Frame: 2-week-post treatment.
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2-week-post treatment.
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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, 3 month-follow-up.
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(changes between assessments)
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Baseline, two-week-post treatment, 3 month-follow-up.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SkaneU2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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