Internet-delivered Trauma-focused Cognitive-behavioral Therapy as an Early Intervention After Sexual Trauma

The research aims to assess the practicality and implementation aspects, effectiveness, and processes of change related to Condensed Internet-delivered Prolonged Exposure (CIPE) administered as an early trauma focused intervention after sexual assault. Eligible participants are individuals seeking help at Traumamottagning Centrum för Sexuell Hälsa, Malmö who have been exposed to sexual assualt in the past two months and exhibit psychological symptoms in response to that.

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 30 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 level of symptoms of post traumatic stress rated by the PCL-5. Secondary outcomes are level of symptoms of post traumatic stress using the Clinician Administered PTSD Scale version 5 (CAPS-5) and The International Trauma Questionnaire (ITQ), level of depression (PHQ-9), quality of life (WSAS and EQ-5D ) dropout rate, rates of inclusion, attrition, adherence,and negative effects.

Qualitative data using a semi-structured interview will be gathered from participants at the end of the treatment collecting data on participants' views on the treatment, preferences for this type of treatment and how to further improve it.

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 for sexual assault at Traumamottagning Centrum för Sexuell Hälsa, Malmö.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• Sweden
  • Malmö, Sweden
    • Traumamottagning Centrum för Sexuell Hälsa, Skånes Universitetssjukhus
    • Contact: Erik Wallmark, MSc; Phone Number: +46(0)40-33 34 46; Email: erik.wallmark@skane.se

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Experienced 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).
• At least mild clinical symptoms assessed using the PCL-5 cut-off >10
• ≥ 18 years
• 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)
• 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.	Baseline, weekly through three weeks of treatment, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month 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.	Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
Clinician Administered PTSD Scale version 5 (CAPS-5), the gold standard clinical interview to assess PTSD symptom severity and diagnosis of PTSD	The CAPS-5 is a 20-item clinical administered interview based upon the Diagnostic and Statistical Manual (DSM-5) criteria for PTSD. Total Score (Range 0-80 with higher scores representing more PTSD symptoms.	Three months after treatment completion.
The International Trauma Questionnaire (ITQ)	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.	Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month 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.	Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
Change in quality of life measured by EQ-5D	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.	Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
Change in use of alcohol measured by Alcohol Use Disorders Identification Test (AUDIT)	point Likert scale (0-4) and differentiates between hazardous alcohol use, dependence symptoms, and harmful alcohol use. The total score of the AUDIT ranges from 0 to 40 points, with a higher score reflecting greater risk of alcohol use disorders.	Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
Change in drug use measured by Drug Use Disorders Identification Test (DUDIT)	Self-rated questionnaire on drug use. It contains 11 items that are scored on a five-point Likert scale (0-4) and differentiates between hazardous drug use, dependence symptoms, and harmful drug use. The total score of the DUDIT ranges from 0 to 44 points, with a higher score reflecting greater risk of drug use disorders.	Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Rates of inclusion to the study	Data on rates of inclusion will be considered as an indication of the feasibility of the intervention.	Baseline
Adverse events related to treatment measured by an openended question	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.	Baseline, weekly through three weeks of treatment, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
Adverse events realted to treatment measured by Negative effects questionnaire (NEQ)	Self-rated questionnaire on negative effects. It contains 32 items that are scored on a five point Likert-scale (0-4) and differentiates between negative effects that are attributed to treatment and those possibly caused by other circumstances. The total score of the NEQ ranges from 0 to 80 points, a higher score reflects more negative effects.	Post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
Participants satisfaction with treatment	Qualitative questions pertaining participants satisfaction with the treatment.	Immediately after treatment completion.
Participants satisfaction with treatment as measured by the 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.	Immediately after treatment completion.
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 3 weeks
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 3 weeks
Number of drop-outs from treatment	Number of drop-outs from treatment	Baseline up to three weeks]
Level of perceived socialm support measured by Multidimensional Scale of Perceived Social Support (MSPSS)	Self-rated questionnaire on perceived social support. It contains 12 items that are scored on a seven-point Likert scale (1-7) and differentiates between perceived support from family, friends, and a significant other. The total score of the MSPSS ranges from 12 to 84 points, with a higher score reflecting greater perceived social support.	Baseline, post-treatment (immediately efter treatment completion)and at the 1, 3, 6 and 12-month follow up.

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Traumamottagning Centrum för Sexuell Hälsa, Skånes Universitetssjukhus, Malmö
• Investigators: Principal Investigator: Maria Bragesjö, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: July 9, 2024
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 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; condensed prolonged exposure; CIPE; internetdelivered
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic, Acute; Sexual Trauma
• Other Study ID Numbers: 2024-01105-01

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