A Feasibility Study of Intensive Treatment With Prolonged Exposure

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Feasibility Study of Intensive Treatment With Prolonged Exposure for Patients With Post-traumatic Stress Disorder (PTSD) in a Regular Health Care Setting

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Intensive treatment with prolonged exposure


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive treatment with prolonged exposure<br>Intensive treatment with prolonged exposure | Behavioral: Intensive treatment with prolonged exposure<br>* Intensive treatment with prolonged exposure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of imaginal exposures made by the participant during the treatment period |  | Through treatment, up to the last session delivered eight weeks after the massed treatment week | 
| Number of in vivo exposures made by the participant during the treatment period |  | 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 |  | Through study completion up to the 6 months follow up | 
| The proportion of participants that go through the entire treatment period |  | Completion of treatment period, up to the last session delivered eight weeks after the massed treatment week | 
| Adverse events related to the treatment | Treatment acceptability | Through study completion, up to the 6 months follow up | 
| Number of drop-outs from treatment | Treatment acceptability | Completion of treatment period, up to the last session delivered eight weeks after the massed treatment week | 
| Number of individuals offered the intervention but declined part of treatment | Treatment acceptability | Baseline | 
| Participants experience/satisfaction with treatment and assessment procedures through qualitative interviews | Qualitative interviews | Completion of the massed treatment period up to post-treatment | 
| Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8). | 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. | Completion of the massed treatment period (one week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5) | The CAPS-5 is structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria for PTSD (Weathers et al., 2013). Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms. Total Score (Range 0-80 with higher scores representing more PTSD symptoms. | Pre-treatment, 6 months follow up | 
| Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5) | The PCL-5 is a 20-item self-report measure based upon the Diagnostic and Statistical Manual (DSM-5) criteria for PTSD. Total Score (Range 0-80 with higher scores representing more PTSD symptoms. | 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). | The ITQ includes six items measuring each PTSD symptom cluster and these items measure how bothersome each symptom has been in the past month. The ITQ also includes six items measuring each 'Disturbance in Self-Organization' (DSO) symptom in complex PTSD. These items measure how a respondent typically feels, thinks about oneself, and relates to others. The PTSD and DSO symptoms are accompanied by three items measuring associated functional impairments in the domains of social, occupation, and other important areas of life. All items are answered on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Extremely). Thus, PTSD and DSO symptom scores range from 0 to 24 and CPTSD symptom scores range from 0 to 48. Higher scores represents more PTSD and complex PTSD symptoms. | 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) | The PHQ-9 is a widely used and well-validated instrument for measuring the severity of depressive symptoms. Scores are calculated based on how frequently a person experiences 9 symptoms of depression ranging from not at all response is scored as 0; several days response is 1; more than half the days response is 2; and nearly every day response is 3. Higher scores represents more depressive symptoms. | 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 | Change in overall health from baseline to post treatment and follow up . EQ-5D is a standardized self-report measure of overall health status measured in terms of five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in work, study, housework, family or leisure activities. In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The respondents self-rate their level of severity for each dimension using a three-level scale: 1 having no problems, 2 having some problems and 3 having extreme problems. A higher score indicate worse severity. | Baseline, last 1 day of the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, prolonged exposure, intensive treatment, massed treatment