RecruitingNot ApplicableNCT05934175

Intensive Treatment Versus Standard Weekly Prolonged Exposure for Adults With Post-Traumatic Stress Disorder

Efficacy, Mechanisms of Change and Cost Effectiveness of Intensive Exposure-based Treatment for PTSD: a Randomized Controlled Trial


Sponsor

Karolinska Institutet

Enrollment

140 participants

Start Date

Sep 4, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to compare a novel, massed treatment format of prolonged exposure to gold standard trauma focused cognitive behavioral therapy (weekly delivered prolonged exposure) for post-traumatic stress disorder. The objective with this study is to investigate efficacy, mechanisms of change and cost effectiveness of intensive prolonged exposure (I-PE) in regular Swedish psychiatric care. Adult patients with post-traumatic stress disorder will be randomly assigned to receive either gold standard prolonged exposure weekly for 15 weeks or 5 days of intensive treatment with the addition of three booster sessions dispersed 1, 2 and 4 weeks after completion of the massed treatment period. Qualitative interviews will be conducted with therapists to explore their experiences of delivering intensive treatment for PTSD, with particular focus on perceived benefits and challenges, clinical processes, patient engagement, and the impact of the intensive format on therapeutic work.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • years of age or above,
  • Primary PTSD diagnosis
  • Fluent in Swedish
  • Sign informed consent
  • Able to attend either I-PE or 15 weekly sessions of PE

Exclusion Criteria4

  • Initiation or adjustment of any psychotropic medication within the last 4 weeks prior to commencement of treatment
  • Serious mental health symptoms, such as mania, psychosis, alcohol, or substance use disorders or current suicide risk warranting immediate clinical attention
  • Ongoing evidence-based trauma-focused psychological treatment
  • Ongoing trauma-related threat (e.g. living with a violent spouse)

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Interventions

BEHAVIORALIntensive treatment with prolonged exposure

Intensive treatment with prolonged exposure

BEHAVIORALWeekly delivered prolonged exposure

Weekly delivered prolonged exposure sessions for 15 weeks


Locations(1)

Traumaprogrammet, Psykiatri Sydväst

Stockholm, Sweden

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NCT05934175


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