Clinical trial NCT05207462: A Feasibility Study of Intensive Treatment With Prolonged Exposure
Official title: A Feasibility Study of Intensive Treatment With Prolonged Exposure for Patients With Post-traumatic Stress Disorder (PTSD) in a Regular Health Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: PTSD
prolonged exposure
intensive treatment
massed treatment
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2022-01-26
Enrollment: 33
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 massed format with a total of nine 60 minutes sessions of imaginal exposure and processing and five 2 hour group session with psychoeducation, rationales and in vivo exposure during one treatment week followed by three individual 60 minutes sessions 2, 4 and 8 weeks afterwards.
Primary purpose: TREATMENT

Brief summary: The primary objective with this study is to investigate the feasibility and acceptability of intensive treatment with prolonged exposure (I-PE) in regular Swedish psychiatric care. The secondary objective is to investigate preliminary effects of i-PE in terms of reducing symptoms of post-traumatic stress, depression and increase quality of life.

Detailed description: The investigators will investigate I-PE delivered as a one-week intensive treatment consisting of nine individual sessions and five group sessions followed by three individual session two, four and eight weeks afterwards in a pilot trial. 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. The individual sessions will consist of imaginal exposure and processing and the group sessions of psychoeducation, rationale for treatment and in vivo exposure work. Recruitment is designed to be broadly inclusive with minimal exclusion criteria. Patients will be recruited from a psychiatric clinic specialised in PTSD in Stockholm, Sweden.

Eligibility criteria: Inclusion Criteria:

* Meet criteria for PTSD
* If taking psychotropic medication, then the dose must be stable for at least 4 weeks prior to study entry
* ≥ 18 years
* Fluent in Swedish
* Signed informed consent

Exclusion Criteria:

* Other serious comorbidity as primary concern (for example ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, high suicidal risk)
* Other 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 treatment, up to the last session delivered eight weeks after the massed treatment week
measure: Number of in vivo exposures made by the participant during the treatment period
timeFrame: Through treatment, up to up to the last session delivered eight weeks after the massed treatment week
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 treatment period, up to the last session delivered eight weeks after the massed treatment week
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 treatment period, up to the last session delivered eight weeks after the massed treatment week
measure: Number of individuals offered the intervention but declined part of treatment
timeFrame: Baseline
measure: Participants experience/satisfaction with treatment and assessment procedures through qualitative interviews
timeFrame: Completion of the massed treatment period up to post-treatment
measure: Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8).
timeFrame: Completion of the massed treatment period (one week)
Secondary outcomes:
measure: Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)
timeFrame: Pre-treatment, 6 months follow up
measure: Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
timeFrame: Baseline, daily through the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.
measure: Change in ICD-11 PTSD and complex PTSD symptoms as assessed by the International Trauma Questionnaire (ITQ).
timeFrame: Baseline, daily through the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.
measure: Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, last 1 day of the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.
measure: Change in quality of life measured by Euroqol, EQ-5D
timeFrame: Baseline, last 1 day of the treatment 1 week, at the 2, 4 and 8 week sessions and the 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: