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A Feasibility Study of Intensive Treatment With Prolonged Exposure

NCT ID: NCT05207462

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

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-24

Study Completion Date

2023-07-22

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Post Traumatic Stress Disorder

Keywords

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PTSD prolonged exposure intensive treatment massed treatment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prolonged exposure will be offered in a massed format with a total of nine 60 minutes sessions of imaginal exposure and processing and five 2 hour group session with psychoeducation, rationales and in vivo exposure during one treatment week followed by three individual 60 minutes sessions 2, 4 and 8 weeks afterwards.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intensive treatment with prolonged exposure

Intensive treatment with prolonged exposure

Group Type EXPERIMENTAL

Intensive treatment with prolonged exposure

Intervention Type BEHAVIORAL

Intensive treatment with prolonged exposure

Interventions

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Intensive treatment with prolonged exposure

Intensive treatment with prolonged exposure

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
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

Other Identifiers

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2021-06004-01

Identifier Type: -

Identifier Source: org_study_id