A Feasibility Study of Intensive Treatment With Prolonged Exposure

Post Traumatic Stress Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05207462
• Other study ID #: 2021-06004-01
• Status: Completed
• Phase: N/A
• Start date: January 24, 2022
• Est. completion date: July 22, 2023

Study information

• Verified date: December 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 22, 2023
• Est. primary completion date: July 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Intensive treatment with prolonged exposure
Intensive treatment with prolonged exposure

Locations

Country	Name	City	State
Sweden	Traumaprogrammet, Psykiatri Sydväst	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	The proportion of participants that conducts the weekly measures and further assessment points		Through study completion up to the 6 months follow up
Primary	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
Primary	Adverse events related to the treatment	Treatment acceptability	Through study completion, up to the 6 months follow up
Primary	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
Primary	Number of individuals offered the intervention but declined part of treatment	Treatment acceptability	Baseline
Primary	Participants experience/satisfaction with treatment and assessment procedures through qualitative interviews	Qualitative interviews	Completion of the massed treatment period up to post-treatment
Primary	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	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.