A Feasibility Study of Intensive Treatment With Prolonged Exposure for Patients With Post-traumatic Stress Disorder (PTSD) in a Regular Health Care Setting
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- The proportion of participants that go through the entire treatment period
Study Overview
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.
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
- •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)
Outcomes
Primary Outcomes
The proportion of participants that go through the entire treatment period
Time Frame: Completion of treatment period, up to the last session delivered eight weeks after the massed treatment week
Number of imaginal exposures made by the participant during the treatment period
Time Frame: Through treatment, up to the last session delivered eight weeks after the massed treatment week
Number of individuals offered the intervention but declined part of treatment
Time Frame: Baseline
Treatment acceptability
Number of in vivo exposures made by the participant during the treatment period
Time Frame: Through treatment, up to up to the last session delivered eight weeks after the massed treatment week
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
Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8).
Time Frame: Completion of the massed treatment period (one week)
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.
Adverse events related to the treatment
Time Frame: Through study completion, up to the 6 months follow up
Treatment acceptability
Participants experience/satisfaction with treatment and assessment procedures through qualitative interviews
Time Frame: Completion of the massed treatment period up to post-treatment
Qualitative interviews
Number of drop-outs from treatment
Time Frame: Completion of treatment period, up to the last session delivered eight weeks after the massed treatment week
Treatment acceptability
Secondary Outcomes
- Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)(Pre-treatment, 6 months follow up)
- Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)(Baseline, daily through the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.)
- Change in ICD-11 PTSD and complex PTSD symptoms as assessed by the International Trauma Questionnaire (ITQ).(Baseline, daily through the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.)
- Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)(Baseline, last 1 day of the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.)
- Change in quality of life measured by Euroqol, EQ-5D(Baseline, last 1 day of the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.)
Investigators
Maria Bragesjo
Principal investigator
Karolinska Institutet