Chronic Pain, PTSD
Conditions
Brief summary
The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy for youth with PTSD and comorbid chronic pain. A pilot study (no randomization; N=5-10) will be conducted to test the intervention and assessment procedures. 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 youth with PTSD and comorbid chronic pain. Sample size: 5-10 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 be collected at this time, post treatment (2 weeks after treatment) as well as during a 3-month follow up. 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 a clinical interview 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 a short daily diary during the baseline and treatment phases. 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 A single-case design with daily data collection during a baseline phase (A) and an intervention phase (B) will also be used. The treatment intervention spans 10 weeks. For the daily data collection, a shortened set of measures comprising approximately 10 items focusing on ptsd symptoms, psychological flexibility, and pain intensity will be used. Data will be collected via a digital platform, with secure handling of any personal data. 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. Randomization test for the A/B single case data collection will be conducted.
Interventions
BEHAVIORALiACT
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.
Sponsors
Skane University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Masking Description
Intervention model description
Model Description
Eligibility
Sex/Gender
ALL
Age
15 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
* a CAPS of ≥25 and a diagnosis of PTSD * subjected to single traumatic events * aged 15-24 years * 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 (ADHD, autism spectrum disorder, 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD symptom severity as measured by the the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) | Baseline, two-week-post treatment, 3 month-follow-up. | The scale ranges from 0-80 and higher sores indicate greater severity of PTSD symptoms. |
| Psychological inflexibility | Baseline, two-week-post treatment, 3 month-follow- up | As measured by the Psychological Inflexibility in Pain Scale (PIPS) (changes between assessments) Min=0; Max= 52. Higher scores indicate worse inflexibility |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety and depression | Baseline, two-week-post treatment, 3 month-follow up | As measured by the Hospital Anxiety and Depression Scale (HADS) (changes between assessments) Min= 0; Max= 21. Higher scores indicate worse depression/anxiety. |
| Pain intensity | Baseline, two-week-post treatment, 3 month-follow- up | As measured by the Numerical Rating Scale (NRPS) (changes between assessments) Min= 0; Max= 10. Higher scores indicate worse pain intensity. |
| General acceptance | Baseline, two-week-post treatment, 3 month-follow-up | As measured by the Swedish Acceptance and Action Questionnaire (SAAQ) (changes between assessments) |
Countries
Sweden
Contacts
CONTACTSophia Åkerblom, Associate professor
PRINCIPAL_INVESTIGATORSophia Åkerblom, phd
Skane University Hospital
Outcome results
None listed