Clinical trial NCT05560854: A Feasibility Study of Internet Delivered Prolonged Exposure
Official title: A Feasibility Study of Internet Delivered Prolonged Exposure for Patients Wit Post-traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: Prolonged exposure
Internet-delivered
PTSD
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2022-09-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prolonged exposure will be offered in a digital format with therapist support for ten weeks. Treatment comprises of psychoeducation, rationales, in vivo exposure, imaginal exposure, problems that can arise during exposure, hot spots and relapse prevention.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of imaginal exposures made by the participant during the treatment period
timeFrame: Through the treatment period, up to 10 weeks
measure: Number of in vivo exposures made by the participant during the treatment period
timeFrame: Through the treatment period, up to 10 weeks
measure: The proportion of participants that conducts the weekly measures and further assessment points
timeFrame: Through study completion up to the 6 months follow up]
measure: The proportion of participants that go through the entire treatment period
timeFrame: Completion of the treatment period, ten weeks
measure: Adverse events related to the treatment
timeFrame: Through study completion, up to the 6 months follow up
measure: Number of drop-outs from treatment
timeFrame: Completion of the treatment period, up to 10 weeks
measure: Participants experience/satisfaction with treatment and assessment procedures through qualitative interviews
timeFrame: Completion of the treatment period up to the 6-month follow up
measure: Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8).
timeFrame: Completion of the treatment period, up to 10 weeks
Secondary outcomes:
measure: Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)
timeFrame: Baseline, 1 month and 6 months follow up
measure: Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
timeFrame: 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.
measure: Change in ICD-11 PTSD and complex PTSD symptoms as assessed by the International Trauma Questionnaire (ITQ).
timeFrame: 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.
measure: Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, post-treatment (immediately after treatment completion at 10 weeks), and the 1 month and 6 months follow up.
measure: Change in quality of life measured by Euroqol, EQ-5D
timeFrame: Baseline, post-treatment (immediately after treatment completion at 10 weeks), and the 1 month and 6 months follow up.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Traumaprogrammet, Psykiatri Sydväst
Study officials:
affiliation: Karolinska Institutet
name: Maria Bragesjö, PhD
role: PRINCIPAL_INVESTIGATOR
References: