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Post Traumatic Stress DisorderNCT05560854

A Feasibility Study of Internet Delivered Prolonged Exposure

A study testing Internet delivered prolonged exposure in people with Post Traumatic Stress Disorder, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post Traumatic Stress Disorder
What is being tested?
Internet delivered prolonged exposure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSweden
Study dates
18 Oct 2022to 9 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Traumaprogrammet, Psykiatri Sydväst

    Stockholm

Other trials in Sweden

About this study

Official title: A Feasibility Study of Internet Delivered Prolonged Exposure for Patients Wit Post-traumatic Stress Disorder

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.

Read the 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.

Being tested
Internet delivered prolonged exposure
Keywords
Prolonged exposure, Internet-delivered, PTSD
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet delivered prolonged exposureBehavioural

    Internet delivered prolonged exposure for ten weeks with therapist support.

Study groups in NCT05560854
Study groupRoleWhat they receive
Internet delivered prolonged exposureExperimentalInternet delivered prolonged exposure for ten weeks with therapist support.
Receives: Behavioral: Internet delivered prolonged exposure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of imaginal exposures made by the participant during the treatment period

    Number of imaginal exposures made by the participant during the treatment

    Measured: Through the treatment period, up to 10 weeks

  2. 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

    Measured: Through the treatment period, up to 10 weeks

  3. 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

    Measured: Through study completion up to the 6 months follow up]

  4. The proportion of participants that go through the entire treatment period

    The proportion of participants that go through the entire treatment period

    Measured: Completion of the treatment period, ten weeks

  5. Adverse events related to the treatment

    Treatment acceptability

    Measured: Through study completion, up to the 6 months follow up

  6. Number of drop-outs from treatment

    Treatment acceptability

    Measured: Completion of the treatment period, up to 10 weeks

  7. Participants experience/satisfaction with treatment and assessment procedures through qualitative interviews

    Qualitative interviews

    Measured: Completion of the treatment period up to the 6-month follow up

  8. 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.

    Measured: Completion of the treatment period, up to 10 weeks

Secondary outcomes (5)

  1. 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.

    Measured: Baseline, 1 month and 6 months follow up

  2. 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.

    Measured: 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.

  3. 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.

    Measured: 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.

  4. 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.

    Measured: Baseline, post-treatment (immediately after treatment completion at 10 weeks), and the 1 month and 6 months follow up.

  5. 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.

    Measured: Baseline, post-treatment (immediately after treatment completion at 10 weeks), and the 1 month and 6 months follow up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2022
  2. Study start18 Oct 2022
  3. Primary completion9 Sep 2023
  4. Study completion9 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05560854
Sponsor's protocol ID
2022-03465-01
Status last verified
Dec 2023
First submitted
23 Sep 2022
Last updated
7 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bragesjo M, Ivanov VZ, Andersson E, Ruck C. Exploring the feasibility and acceptance of huddinge online prolonged exposure therapy (HOPE) for severe and complex PTSD. Eur J Psychotraumatol. 2024;15(1):2320607. doi: 10.1080/20008066.2024.2320607. Epub 2024 Mar 4.

    PubMed 38436944

Questions about this trial

What is this clinical trial studying?

A study testing Internet delivered prolonged exposure in people with Post Traumatic Stress Disorder, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of imaginal exposures made by the participant during the treatment period (time frame: Through the treatment period, up to 10 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05560854, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.

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