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A Feasibility Study of Internet Delivered Prolonged Exposure

NCT ID: NCT05560854

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-18

Study Completion Date

2023-09-09

Brief Summary

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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

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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.

Conditions

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Post Traumatic Stress Disorder

Keywords

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Prolonged exposure Internet-delivered PTSD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Internet delivered prolonged exposure

Internet delivered prolonged exposure for ten weeks with therapist support.

Group Type EXPERIMENTAL

Internet delivered prolonged exposure

Intervention Type BEHAVIORAL

Internet delivered prolonged exposure for ten weeks with therapist support.

Interventions

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Internet delivered prolonged exposure

Internet delivered prolonged exposure for ten weeks with therapist support.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Maria Bragesjo

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Bragesjö, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Traumaprogrammet, Psykiatri Sydväst

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 38436944 (View on PubMed)

Other Identifiers

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2022-03465-01

Identifier Type: -

Identifier Source: org_study_id