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Completed

NCT Number: NCT05207462

A Feasibility Study of Intensive Treatment With Prolonged Exposure

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.

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Traumaprogrammet, Psykiatri Sydväst

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intensive treatment with prolonged exposure

Behavioral

Intensive treatment with prolonged exposure

Primary outcomes

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

    Time frame: Through treatment, up to the last session delivered eight weeks after the massed treatment week

  2. Number of in vivo exposures made by the participant during the treatment period

    Time frame: Through treatment, up to up to the last session delivered eight weeks after the massed treatment week

  3. The proportion of participants that conducts the weekly measures and further assessment points

    Time frame: Through study completion up to the 6 months follow up

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

    Time frame: Completion of treatment period, up to the last session delivered eight weeks after the massed treatment week

  5. Adverse events related to the treatment

    Time frame: Through study completion, up to the 6 months follow up

    Treatment acceptability

  6. Number of drop-outs from treatment

    Time frame: Completion of treatment period, up to the last session delivered eight weeks after the massed treatment week

    Treatment acceptability

  7. Number of individuals offered the intervention but declined part of treatment

    Time frame: Baseline

    Treatment acceptability

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

    Time frame: Completion of the massed treatment period up to post-treatment

    Qualitative interviews

  9. Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8).

    Time frame: Completion of the massed treatment period (one week)

    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.

Secondary outcomes

  1. Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)

    Time frame: Pre-treatment, 6 months follow up

    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.

  2. Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)

    Time frame: Baseline, daily through the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.

    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.

  3. Change in ICD-11 PTSD and complex PTSD symptoms as assessed by the International Trauma Questionnaire (ITQ).

    Time frame: Baseline, daily through the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.

    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.

  4. Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline, last 1 day of the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.

    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.

  5. Change in quality of life measured by Euroqol, EQ-5D

    Time frame: Baseline, last 1 day of the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.

    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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

A Feasibility Study of Intensive Treatment With Prolonged Exposure for Patients With Post-traumatic Stress Disorder (PTSD) in a Regular Health Care Setting

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 26, 2022
Registry last updated
Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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