Condensed Digital Prolonged Exposure for Individuals Treated Within Somatic Trauma Care. (CiPE)

Internet Delivered Condensed Cognitive Behavioral Treatment (Prolonged Exposure) for Individuals Treated Within Somatic Trauma Care.

The purpose of the study is to investigate the feasibility of implementation aspects, treatment effects and change processes regarding a brief trauma-focused Internet-based CBT treatment, for patients who have been treated in trauma care at Karolinska University Hospital and who exhibit symptoms of psychological consequences of the traumatic event. Another aim is to explore factors (predictors, moderators and mediators) that influence the effect of the treatment, in order to better understand who responds to the treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Post Traumatic Stress Disorder; Acute Stress Disorder
• Intervention / Treatment: Behavioral: Condensed Internet delivered prolonged exposure (CIPE)

Detailed Description

The study is un-controlled with 250 participants that will undergo a brief trauma-focused Internet-based CBT treatment, delivered as a three-week treatment comprising of four modules (psychoeducation/rational, in vivo exposure, imaginal exposure and relapse prevention). The primary outcome is the PCL-5. Secondary outcomes are level of depression (PHQ-9), quality of life (WSAS) and predictors, moderators and mediators of clinically meaningful change in symptoms, dropout rate, rates of inclusion, attrition, adherence,and negative effects.

Self-reported, qualitative data from participants will be gathered at treatment completion to capture participants' experiences of participating in the intervention, as well as their views on how to further improve the intervention. The treatment effects will be evaluated using a within-group design with repeated measurements. Participants in the study will be will recruited from patients treated in the somatic trauma care at the Karolinska University Hospital in Stockholm, Sweden.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Bragesjö, PhD; Phone Number: +46703399387; Email: maria.bragesjo@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Karolinska Universitetssjukhuset; Tema Kvinnohälsa och Hälsoprofessioner; Medicinsk Enhet Medicinsk Psykologi; Sektion Beteendemedicin
    • Contact: Charlotte Gentili, PhD; Phone Number: +46760482895; Email: charlotte.s.gentili@regionstockholm.se
    • Contact: Mike Kemani, PhD; Email: mike.kemani@regionstockholm.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Exposed to trauma in the past two months according to criterion A for PTSD in the DSM-5 (exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence).
• PCL-5 total sum score>10
• ≥ 18 years
• Situated in Sweden
• Signed informed consent

Exclusion Criteria:

• Other serious comorbidity as primary concern (ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, borderline personality disorder, high suicidal risk according to the MINI)
• Unable to read and write in Swedish
• Receiving other psychological trauma-focused treatment
• Ongoing trauma-related threat (e.g., living with a violent spouse)
• Not stable dose of antidepressant medication the last two weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Condensed Internet delivered prolonged exposure (CIPE); Condensed Internet delivered prolonged exposure (CIPE) for three weeks with therapist support.	Behavioral: Condensed Internet delivered prolonged exposure (CIPE); Condensed Internet delivered prolonged exposure (CIPE) with therapist support for three weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)	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.	week -3, -2 and -1 before treatment start, immediately before start of treatment, weekly through three weeks of treatment, post-treatment (immediately after treatment completion at three weeks), and the 1 month and 6 months follow up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)	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.	week -3 before treatment start, immediately before start of treatment, weekly through three weeks of treatment, post-treatment (immediately after treatment completion at three weeks), and the 1 month and 6 months follow up.
Change in psychosocial impairment measured by The Work and Social Adjustment Scale (WSAS), adapted to symptoms of post-traumatic stress.	WSAS is a short, self-reported instrument consisting of five items about psychosocial impairments rated on a nine-point Likert scale. A higher score means more severe impairment.	week -3 before treatment start, immediately before start of treatment, , weekly through three weeks of treatment, post-treatment (immediately after treatment completion at three weeks), and the 1 month and 6 months follow up.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants satisfaction with treatment.	Qualitative questions pertaining participants satisfaction with the treatment.	Immediately after treatment completion.
Adverse events related to treatment.	Adverse events related to treatment measured by with a free text option where participant is instructed to describe the possible event in detail. If the participant reported any adverse event, additional follow-up questions about intensity, duration etc. will also be given.	Immediately after treatment completion.
Number of completed treatment modules	Data will be gathered on total number of completed modules during the three week treatment.	Baseline up to 3 weeks
Number of messages sent and received in the digital platform	Data will be gathered on total number of messages sent and received in the digital platform during the three week treatment.	Baseline up to 3 weeks
Number of completed home work assignments by the participant during the treatment period	Data will be gathered on total number of completed home work assignments by the participant during the three week treatment.	Baseline up to 3 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	Baseline up to 6 months
The proportion of participants that go through the entire treatment period	The proportion of participants that go through the entire treatment period	Baseline up to three weeks
Number of drop-outs from treatment	Number of drop-outs from treatment	Baseline up to three weeks
Rates of inclusion to the study	Data on rates of inclusion will be considered as an indication of the feasibility of the intervention.	Baseline

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Karolinska Universitetssjukhuset
• Investigators: Principal Investigator: Maria Bragesjö, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: PTSD; trauma; prevention; early intervention; Internet-delivered; condensed prolonged exposure; CIPE
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic, Acute
• Other Study ID Numbers: 2023-06821-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No