A Feasibility Study of Internet Delivered Prolonged Exposure for Patients Wit Post-traumatic Stress Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Number of drop-outs from treatment
Study Overview
Brief Summary
The primary objective with this study is to investigate the feasibility and acceptability of ten weeks of internet delivered prolonged exposure delivered through a digital platform with therapist support. The secondary objective is to investigate preliminary effects of internet delivered prolonged exposure in terms of reducing symptoms of post-traumatic stress, depression and increase quality of life.
Detailed Description
The investigators will investigate internet delivered prolonged exposure delivered as a ten-week treatment comprising of six modules (psychoeducation/rational, in vivo exposure, imaginal exposure, common problems during exposure, hot spots and relapse prevention). The feasibility and acceptability and preliminary effects of treatment- and assessment procedures will be evaluated using a within-group design with repeated measurements and qualitative interviews. Recruitment is designed to be broadly inclusive with minimal exclusion criteria. Patients will be recruited from a psychiatric clinic specialized in PTSD in Stockholm, Sweden and by advertisements in newspapers and social media.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Currently primary diagnosis PTSD according to DSM-5 diagnostic criteria for PTSD
- •≥ 18 years
- •Fluent in Swedish
- •Signed informed consent
Exclusion Criteria
- •PTSD is not the primary concern
- •Initiation or adjustment of any psychotropic medication within the last 4 weeks prior to commencement of treatment
- •Ongoing substance dependence
- •Current suicide risk meriting crisis intervention
- •Psychotic disorder
- •Ongoing trauma-focused psychological treatment
- •Ongoing trauma-related threat (e.g. living with a violent spouse)
Arms & Interventions
Internet delivered prolonged exposure
Internet delivered prolonged exposure for ten weeks with therapist support.
Intervention: Internet delivered prolonged exposure (Behavioral)
Outcomes
Primary Outcomes
Number of drop-outs from treatment
Time Frame: Completion of the treatment period, up to 10 weeks
Treatment acceptability
Number of in vivo exposures made by the participant during the treatment period
Time Frame: Through the treatment period, up to 10 weeks
Number of in vivo exposures made by the participant during the treatment period
Adverse events related to the treatment
Time Frame: Through study completion, up to the 6 months follow up
Treatment acceptability
Number of imaginal exposures made by the participant during the treatment period
Time Frame: Through the treatment period, up to 10 weeks
Number of imaginal exposures made by the participant during the treatment
The proportion of participants that conducts the weekly measures and further assessment points
Time Frame: Through study completion up to the 6 months follow up]
The proportion of participants that conducts the weekly measures and further assessment points
Participants experience/satisfaction with treatment and assessment procedures through qualitative interviews
Time Frame: Completion of the treatment period up to the 6-month follow up
Qualitative interviews
Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8).
Time Frame: Completion of the treatment period, up to 10 weeks
The CSQ-8 yields a single score measuring a single dimension of overall satisfaction. An "overall score" is calculated by summing the score on each of the eight scale item. Scores range from 8 to 32, with higher values indicating higher satisfaction.
The proportion of participants that go through the entire treatment period
Time Frame: Completion of the treatment period, ten weeks
The proportion of participants that go through the entire treatment period
Secondary Outcomes
- Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)(Baseline, 1 month and 6 months follow up)
- Change in ICD-11 PTSD and complex PTSD symptoms as assessed by the International Trauma Questionnaire (ITQ).(Baseline, weekly through 10 weeks of treatment, post-treatment (immediately after treatment completion at 10 weeks), and the 1 month and 6 months follow up.)
- Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)(Baseline, post-treatment (immediately after treatment completion at 10 weeks), and the 1 month and 6 months follow up.)
- Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)(Baseline, weekly through 10 weeks of treatment, post-treatment (immediately after treatment completion at 10 weeks), and the 1 month and 6 months follow up.)
- Change in quality of life measured by Euroqol, EQ-5D(Baseline, post-treatment (immediately after treatment completion at 10 weeks), and the 1 month and 6 months follow up.)
Investigators
Maria Bragesjo
Principal investigator
Karolinska Institutet