A Feasibility Study of Internet Delivered Prolonged Exposure

NCT05560854 | Completed

• 1 other identifier: 2022-03465-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Traumatic Stress Disorder

Keywords

Prolonged exposure; Internet-delivered; PTSD

Outcome Measures

Primary Outcomes (8)

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

  Number of imaginal exposures made by the participant during the treatment

  Through the treatment period, up to 10 weeks

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

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

  Through the treatment period, up to 10 weeks

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

  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

  The proportion of participants that go through the entire treatment period

  Completion of the treatment period, ten weeks

• 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 the treatment period, up to 10 weeks

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

  Qualitative interviews

  Completion of the treatment period up to the 6-month follow up

• 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 treatment period, up to 10 weeks

Secondary Outcomes (5)

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

  Baseline, 1 month and 6 months follow up

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

  Baseline, weekly through 10 weeks of treatment, post-treatment (immediately after treatment completion at 10 weeks), and the 1 month and 6 months follow up.

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

  Baseline, weekly through 10 weeks of treatment, post-treatment (immediately after treatment completion at 10 weeks), and the 1 month and 6 months follow up.

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

  Baseline, post-treatment (immediately after treatment completion at 10 weeks), and the 1 month and 6 months follow up.

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

  Baseline, post-treatment (immediately after treatment completion at 10 weeks), and the 1 month and 6 months follow up.

Study Arms (1)

Internet delivered prolonged exposure

EXPERIMENTAL

Internet delivered prolonged exposure for ten weeks with therapist support.

Behavioral: Internet delivered prolonged exposure

Interventions

Internet delivered prolonged exposure BEHAVIORAL

Internet delivered prolonged exposure for ten weeks with therapist support.

Internet delivered prolonged exposure

Eligibility Criteria

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

You may qualify if:

• Currently primary diagnosis PTSD according to DSM-5 diagnostic criteria for PTSD
• ≥ 18 years
• Fluent in Swedish
• Signed informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Traumaprogrammet, Psykiatri Sydväst

Stockholm, Sweden

Location

Related Publications (1)

• 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.

  PMID: 38436944 DERIVED

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 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.

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 29, 2022
• Study Start: October 18, 2022
• Primary Completion: September 9, 2023
• Study Completion: September 9, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)