Back to resultsA Feasibility Study of Intensive Treatment With Prolonged Exposure
Primary Purpose
Post Traumatic Stress Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Intensive treatment with prolonged exposure
Sponsored by
About this trial
This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring PTSD, prolonged exposure, intensive treatment, massed treatment
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)
Sites / Locations
- Traumaprogrammet, Psykiatri SydvästRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intensive treatment with prolonged exposure
Arm Description
Intensive treatment with prolonged exposure
Outcomes
Primary Outcome Measures
Number of imaginal exposures made by the participant during the treatment period
Number of in vivo exposures made by the participant during the treatment period
The proportion of participants that conducts the weekly measures and further assessment points
The proportion of participants that go through the entire treatment period
Adverse events related to the treatment
Treatment acceptability
Number of drop-outs from treatment
Treatment acceptability
Number of individuals offered the intervention but declined part of treatment
Treatment acceptability
Participants experience/satisfaction with treatment and assessment procedures through qualitative interviews
Qualitative interviews
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05207462
First Posted
December 22, 2021
Last Updated
March 28, 2022
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
1. Study Identification
Unique Protocol Identification Number
NCT05207462
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
PTSD, prolonged exposure, intensive treatment, massed treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intensive treatment with prolonged exposure
Arm Type
Experimental
Arm Description
Intensive treatment with prolonged exposure
Intervention Type
Behavioral
Intervention Name(s)
Intensive treatment with prolonged exposure
Intervention Description
Intensive treatment with prolonged exposure
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
Adverse events related to the treatment
Description
Treatment acceptability
Time Frame
Through study completion, up to the 6 months follow up
Title
Number of drop-outs from treatment
Description
Treatment acceptability
Time Frame
Completion of treatment period, up to the last session delivered eight weeks after the massed treatment week
Title
Number of individuals offered the intervention but declined part of treatment
Description
Treatment acceptability
Time Frame
Baseline
Title
Participants experience/satisfaction with treatment and assessment procedures through qualitative interviews
Description
Qualitative interviews
Time Frame
Completion of the massed treatment period up to post-treatment
Title
Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8).
Description
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.
Time Frame
Completion of the massed treatment period (one week)
Secondary Outcome Measure Information:
Title
Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)
Description
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.
Time Frame
Pre-treatment, 6 months follow up
Title
Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
Description
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.
Time Frame
Baseline, daily through the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.
Title
Change in ICD-11 PTSD and complex PTSD symptoms as assessed by the International Trauma Questionnaire (ITQ).
Description
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.
Time Frame
Baseline, daily through the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.
Title
Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
Baseline, last 1 day of the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.
Title
Change in quality of life measured by Euroqol, EQ-5D
Description
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.
Time Frame
Baseline, last 1 day of the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Bragesjö, PhD
Phone
+46703399387
Email
maria.bragesjo@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Bragesjö, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Traumaprogrammet, Psykiatri Sydväst
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Bragesjö, PhD
Email
maria.bragesjo@ki.se
12. IPD Sharing Statement
Plan to Share IPD
No
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A Feasibility Study of Intensive Treatment With Prolonged Exposure
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