Post Traumatic Stress DisorderNCT03850639
An Internet-delivered Cognitive-behavioral Intervention Provided Soon After Trauma
A study testing Internet-based exposure therapy in people with Post Traumatic Stress Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The primary objective with this study is to investigate the feasibility of an internet-delivered cognitive-behavioral (CBT) intervention provided soon after trauma (within 2 months). 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-based exposure therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSweden
- Study dates
- 28 Feb 2019to 5 Jun 2021
- 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
- Experienced psychological trauma according to criterium A for PTSD in the DSM-5 (exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence) the past two months.
- Ongoing intrusive memories from this traumatic event
- ≥ 18 years
- Situated in Sweden
- Informed consent
Who cannot join
- Other serious comorbidity as primary concern (ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, borderline personality disorder, high suicidal risk according to the MINI)
- Not fluent speaking in Swedish
- Receiving CBT for trauma
- Ongoing trauma-related threat (e.g. living with a violent spouse)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Internet-delivered Cognitive-behavioral Intervention Provided Soon After Trauma: a Two-step Feasibility Trial
The primary objective with this study is to investigate the feasibility of an internet-delivered cognitive-behavioral (CBT) intervention provided soon after trauma (within 2 months). The secondary objective is to investigate the effects of the internet-delivered CBT intervention on intrusive memories compared to no treatment.
Read the detailed description
Objective The primary objective with this study is to investigate the feasibility of an internet-delivered psychological intervention provided soon after trauma (within 2 months). The secondary objective is to investigate the effects of the internet-delivered CBT intervention on intrusive memories compared to no treatment.
Trial design We will first pre-pilot test the intervention- and assessment procedures in five participants (no randomization) which will be followed by a randomized controlled trial with waitlist control. The wait list control group will also receive treatment after the first group has finished.
SAMPLE SIZE 5 plus 30 participants.
ENDPOINTS Self-report assessment of daily intrusions at baseline and post-treatment
SECONDARY ENDPOINTS The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) at baseline (and post-treatment Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S) at baseline and post-treatment.
Euroqol, EQ-5D at baseline and post-treatment.
Recruitment Self-referral. Advertising will be made through national newspapers, social media, patient organisations' and ads directed to health care units, such as emergency departments, in Sweden.
Safety parameters Participants will have the opportunity to report any adverse events during treatment at posttreatment and follow-up measurements.
Data collection: Data will be collected electronically via the treatment platform and a safe app.
Main statistical analysis:
Between-group estimates on outcome are done using a mixed-effects regression model with a Poisson distribution. All analyses will be done according to intention to treat and post hoc per protocol analyses will also be conducted. The primary criterion is the estimated regression slope of daily intrusive memories between day 0-7 and day 28-35.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Internet-based exposure therapy
- 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-based exposure therapyBehavioural
The treatment is a three week long cognitive behavior therapy. It is based mainly on the principles of exposure; i.e. the participant is instructed to approach the memory of the traumatic event and situations they since the traumatic events are associated with fear and anxiety. Other interventions include psychoeducation, and breathing retraining to facilitate exposure.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based exposure therapy | Experimental | The experimental group will go through active internet-based treatment which is delivered on a safe internet platform. Treatment is divided into four modules, each containing homework assignments. Participants in experimental group will be assigned a therapist that they can contact through a message system in the platform and expect answer within 48 hours. Receives: Behavioral: Internet-based exposure therapy |
| Wait list control | No intervention | Waitlist control, i.e. no active active intervention during waiting list period. Will be offered treatment after 4 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of intrusion of the traumatic memory
Change in self-report assessment of daily intrusions at baseline (day 0-7) and post-treatment (day 28-35). The participants are each day asked to report number of intrusive memories during morning, afternoon, evening and night through a smart phone app. If the participants don't have access to a smart phone, pen and stencil will be used.
Measured: Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months
Secondary outcomes (3)
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Change in symptoms of post traumatic stress from baseline to post treatment and follow up (6 months). The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. All items are scored on a 0-4 scale. Higher score indicate worse severity.
Measured: Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
Change in depressive symptoms from baseline to post treatment and follow up (6 months). The Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S) is a 9 item self-report measure that assesses the presence and severity of depressive symptoms. All items are scored on a 0-6 scale. Higher score indicate worse severity.
Measured: Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months
Euroqol, EQ-5D
Change in overall health from baseline to post treatment and follow up (6 months). EQ-5D is a standardised 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 (day 0-7), post-treatment (day 28-35) and follow-up 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start28 Feb 2019
- Primary completion2 Dec 2020 (estimated)
- Study completion5 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The experimental group will go through active internet-based treatment which is delivered on a safe internet platform. Treatment is divided into four modules, each containing homework assignments. Participants in experimental group will be assigned a therapist that they can contact through a message system in the platform and expect answer within 48 hours.
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Andersson, Karolinska Institutet
- Investigators
- Erik Andersson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850639
- Sponsor's protocol ID
- EPN 2018/2365-31
- Status last verified
- Oct 2020
- First submitted
- 15 Feb 2019
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bragesjo M, Arnberg FK, Andersson E. Mediators of change in a condensed online exposure-based intervention provided soon after trauma: insights from a randomised controlled trial. Eur J Psychotraumatol. 2024;15(1):2430807. doi: 10.1080/20008066.2024.2430807. Epub 2024 Dec 2.
PubMed 39621100
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Internet-delivered Cognitive-behavioral Intervention Provided Soon After Trauma: a Two-step Feasibility Trial
- ClinicalTrials.gov ID
- NCT03850639
- Acronym / sponsor ID
- EPN 2018/2365-31
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 2 Dec 2020 (estimated)
- Study completion
- 5 Jun 2021 (estimated)
- First posted
- 22 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective with this study is to investigate the feasibility of an internet-delivered cognitive-behavioral (CBT) intervention provided soon after trauma (within 2 months). The secondary objective is to investigate the effects of the internet-delivered CBT intervention on intrusive memories compared to no treatment.
Detailed description
Objective The primary objective with this study is to investigate the feasibility of an internet-delivered psychological intervention provided soon after trauma (within 2 months). The secondary objective is to investigate the effects of the internet-delivered CBT intervention on intrusive memories compared to no treatment.
Trial design We will first pre-pilot test the intervention- and assessment procedures in five participants (no randomization) which will be followed by a randomized controlled trial with waitlist control. The wait list control group will also receive treatment after the first group has finished.
SAMPLE SIZE 5 plus 30 participants.
ENDPOINTS Self-report assessment of daily intrusions at baseline and post-treatment
SECONDARY ENDPOINTS The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) at baseline (and post-treatment Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S) at baseline and post-treatment.
Euroqol, EQ-5D at baseline and post-treatment.
Recruitment Self-referral. Advertising will be made through national newspapers, social media, patient organisations' and ads directed to health care units, such as emergency departments, in Sweden.
Safety parameters Participants will have the opportunity to report any adverse events during treatment at posttreatment and follow-up measurements.
Data collection: Data will be collected electronically via the treatment platform and a safe app.
Main statistical analysis:
Between-group estimates on outcome are done using a mixed-effects regression model with a Poisson distribution. All analyses will be done according to intention to treat and post hoc per protocol analyses will also be conducted. The primary criterion is the estimated regression slope of daily intrusive memories between day 0-7 and day 28-35.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The experimental group will go through active internet-based treatment which is delivered on a safe internet platform. Treatment is divided into four modules, each containing homework assignments. Participants in experimental group will be assigned a therapist that they can contact through a message system in the platform and expect answer within 48 hours.
| Arm | Type | Receives |
|---|---|---|
| Internet-based exposure therapy | Experimental | Behavioral: Internet-based exposure therapyThe experimental group will go through active internet-based treatment which is delivered on a safe internet platform. Treatment is divided into four modules, each containing homework assignments. Participants in experimental group will be assigned a therapist that they can contact through a message system in the platform and expect answer within 48 hours. |
| Wait list control | No intervention | –Waitlist control, i.e. no active active intervention during waiting list period. Will be offered treatment after 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Experienced psychological trauma according to criterium A for PTSD in the DSM-5 (exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence) the past two months.
- Ongoing intrusive memories from this traumatic event
- ≥ 18 years
- Situated in Sweden
- Informed consent
Key exclusion criteria (4 listed)
- Other serious comorbidity as primary concern (ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, borderline personality disorder, high suicidal risk according to the MINI)
- Not fluent speaking in Swedish
- Receiving CBT for trauma
- Ongoing trauma-related threat (e.g. living with a violent spouse)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based exposure therapyThe treatment is a three week long cognitive behavior therapy. It is based mainly on the principles of exposure; i.e. the participant is instructed to approach the memory of the traumatic event and situations they since the traumatic events are associated with fear and anxiety. Other interventions include psychoeducation, and breathing retraining to facilitate exposure. | Behavioural | Internet-based exposure therapy |
Primary outcome
Number of intrusion of the traumatic memory
Time frame: Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months
Change in self-report assessment of daily intrusions at baseline (day 0-7) and post-treatment (day 28-35). The participants are each day asked to report number of intrusive memories during morning, afternoon, evening and night through a smart phone app. If the participants don't have access to a smart phone, pen and stencil will be used.
3 secondary outcomes
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time frame: Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
Time frame: Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months
Euroqol, EQ-5D
Time frame: Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Derived from this study: PubMed 39621100Bragesjo M, Arnberg FK, Andersson E. Mediators of change in a condensed online exposure-based intervention provided soon after trauma: insights from a randomised controlled trial. Eur J Psychotraumatol. 2024;15(1):2430807. doi: 10.1080/20008066.2024.2430807. Epub 2024 Dec 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Andersson, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based exposure therapy 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Oct 2020. 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?
Results are not available in the source record.
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 intrusion of the traumatic memory (time frame: Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months). 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 NCT03850639, 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 19 Oct 2020.