search
Back to results

A Feasibility Study of Internet Delivered Prolonged Exposure

Primary Purpose

Post Traumatic Stress Disorder

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet delivered prolonged exposure
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring Prolonged exposure, Internet-delivered, PTSD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Currently primary diagnosis PTSD according to DSM-5 diagnostic criteria for PTSD
  • ≥ 18 years
  • Fluent in Swedish
  • Signed informed consent

Exclusion Criteria:

  • PTSD is not the primary concern
  • Initiation or adjustment of any psychotropic medication within the last 4 weeks prior to commencement of treatment
  • Ongoing substance dependence
  • Current suicide risk meriting crisis intervention
  • Psychotic disorder
  • Ongoing trauma-focused psychological treatment
  • Ongoing trauma-related threat (e.g. living with a violent spouse)

Sites / Locations

  • Traumaprogrammet, Psykiatri Sydväst

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Internet delivered prolonged exposure

Arm Description

Internet delivered prolonged exposure for ten weeks with therapist support.

Outcomes

Primary Outcome Measures

Number of imaginal exposures made by the participant during the treatment period
Number of imaginal exposures made by the participant during the treatment
Number of in vivo 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 conducts the weekly measures and further assessment points
The proportion of participants that go through the entire treatment period
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
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

First Posted
September 23, 2022
Last Updated
March 7, 2023
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
search

1. Study Identification

Unique Protocol Identification Number
NCT05560854
Brief Title
A Feasibility Study of Internet Delivered Prolonged Exposure
Official Title
A Feasibility Study of Internet Delivered Prolonged Exposure for Patients Wit Post-traumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (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 ten weeks of internet delivered prolonged exposure delivered through a digital platform with therapist support. The secondary objective is to investigate preliminary effects of internet delivered prolonged exposure in terms of reducing symptoms of post-traumatic stress, depression and increase quality of life.
Detailed Description
The investigators will investigate internet delivered prolonged exposure delivered as a ten-week treatment comprising of six modules (psychoeducation/rational, in vivo exposure, imaginal exposure, common problems during exposure, hot spots and relapse prevention). 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. Recruitment is designed to be broadly inclusive with minimal exclusion criteria. Patients will be recruited from a psychiatric clinic specialized in PTSD in Stockholm, Sweden and by advertisements in newspapers and social media.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
Prolonged exposure, Internet-delivered, PTSD

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 digital format with therapist support for ten weeks. Treatment comprises of psychoeducation, rationales, in vivo exposure, imaginal exposure, problems that can arise during exposure, hot spots and relapse prevention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet delivered prolonged exposure
Arm Type
Experimental
Arm Description
Internet delivered prolonged exposure for ten weeks with therapist support.
Intervention Type
Behavioral
Intervention Name(s)
Internet delivered prolonged exposure
Intervention Description
Internet delivered prolonged exposure for ten weeks with therapist support.
Primary Outcome Measure Information:
Title
Number of imaginal exposures made by the participant during the treatment period
Description
Number of imaginal exposures made by the participant during the treatment
Time Frame
Through the treatment period, up to 10 weeks
Title
Number of in vivo exposures made by the participant during the treatment period
Description
Number of in vivo exposures made by the participant during the treatment period
Time Frame
Through the treatment period, up to 10 weeks
Title
The proportion of participants that conducts the weekly measures and further assessment points
Description
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
Description
The proportion of participants that go through the entire treatment period
Time Frame
Completion of the treatment period, ten weeks
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 the treatment period, up to 10 weeks
Title
Participants experience/satisfaction with treatment and assessment procedures through qualitative interviews
Description
Qualitative interviews
Time Frame
Completion of the treatment period up to the 6-month follow up
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 treatment period, up to 10 weeks
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
Baseline, 1 month and 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, weekly through 10 weeks of treatment, post-treatment (immediately after treatment completion at 10 weeks), and the 1 month and 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, weekly through 10 weeks of treatment, post-treatment (immediately after treatment completion at 10 weeks), and the 1 month and 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, post-treatment (immediately after treatment completion at 10 weeks), and the 1 month and 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, post-treatment (immediately after treatment completion at 10 weeks), and the 1 month and 6 months follow up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Currently primary diagnosis PTSD according to DSM-5 diagnostic criteria for PTSD ≥ 18 years Fluent in Swedish Signed informed consent Exclusion Criteria: PTSD is not the primary concern Initiation or adjustment of any psychotropic medication within the last 4 weeks prior to commencement of treatment Ongoing substance dependence Current suicide risk meriting crisis intervention Psychotic disorder Ongoing trauma-focused psychological treatment Ongoing trauma-related threat (e.g. living with a violent spouse)
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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Feasibility Study of Internet Delivered Prolonged Exposure

We'll reach out to this number within 24 hrs