A Feasibility Study of Intensive Treatment With Prolonged Exposure

NCT05207462 | Completed

• 1 other identifier: 2021-06004-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Traumatic Stress Disorder

Keywords

PTSD; prolonged exposure; intensive treatment; massed treatment

Outcome Measures

Primary Outcomes (9)

• Number of imaginal exposures made by the participant during the treatment period

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

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

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

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

  Through study completion up to the 6 months follow up

• The proportion of participants that go through the entire treatment period

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

• Adverse events related to the treatment

  Treatment acceptability

  Through study completion, up to the 6 months follow up

• Number of drop-outs from treatment

  Treatment acceptability

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

• Number of individuals offered the intervention but declined part of treatment

  Treatment acceptability

  Baseline

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

  Qualitative interviews

  Completion of the massed treatment period up to post-treatment

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

  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.

  Completion of the massed treatment period (one week)

Secondary Outcomes (5)

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

  Pre-treatment, 6 months follow up

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

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

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

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

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

  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 quality of life measured by Euroqol, EQ-5D

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

Study Arms (1)

Intensive treatment with prolonged exposure

EXPERIMENTAL

Intensive treatment with prolonged exposure

Behavioral: Intensive treatment with prolonged exposure

Interventions

Intensive treatment with prolonged exposure BEHAVIORAL

Intensive treatment with prolonged exposure

Intensive treatment with prolonged exposure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Traumaprogrammet, Psykiatri Sydväst

Stockholm, Sweden

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Maria Bragesjö, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 26, 2022
• Study Start: January 24, 2022
• Primary Completion: July 22, 2023
• Study Completion: July 22, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)