Clinical trial NCT06502106: Internet-delivered Trauma-focused Cognitive-behavioral Therapy as an Early Intervention After Sexual Trauma
Official title: Internet-delivered Trauma-focused Cognitive-behavioral Therapy as an Early Intervention After Sexual Trauma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Stress Disorder
Post Traumatic Stress Disorder
Keywords: condensed prolonged exposure
PTSD
internetdelivered
trauma
early intervention
prevention
CIPE
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Traumamottagning Centrum för Sexuell Hälsa, Skånes Universitetssjukhus, Malmö
First posted: 2024-07-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prolonged exposure will be offered in a brief digital format with therapist support for three weeks. Treatment comprises of psychoeducation, rationales, in vivo exposure, imaginal exposure and relapse prevention.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
timeFrame: 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 outcomes:
measure: Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
measure: Clinician Administered PTSD Scale version 5 (CAPS-5), the gold standard clinical interview to assess PTSD symptom severity and diagnosis of PTSD
timeFrame: Three months after treatment completion.
measure: The International Trauma Questionnaire (ITQ)
timeFrame: Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
measure: Change in psychosocial impairment measured by The Work and Social Adjustment Scale (WSAS), adapted to symptoms of post-traumatic stress.
timeFrame: Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
measure: Change in quality of life measured by EQ-5D
timeFrame: Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
measure: Change in use of alcohol measured by Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
measure: Change in drug use measured by Drug Use Disorders Identification Test (DUDIT)
timeFrame: Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
Other outcomes:
measure: Adverse events related to treatment measured by an openended question
timeFrame: 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.
measure: Adverse events realted to treatment measured by Negative effects questionnaire (NEQ)
timeFrame: Post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
measure: Participants satisfaction with treatment
timeFrame: Immediately after treatment completion.
measure: Participants satisfaction with treatment as measured by the CSQ-8
timeFrame: Immediately after treatment completion.
measure: Number of completed treatment modules
timeFrame: Baseline up to 3 weeks
measure: Number of completed home work assignments by the participant during the treatment period
timeFrame: Baseline up to 3 weeks
measure: Number of messages sent and received in the digital platform
timeFrame: Baseline up to 3 weeks
measure: The proportion of participants that conducts the weekly measures and further assessment points
timeFrame: Baseline up to 3 weeks
measure: The proportion of participants that go through the entire treatment period
timeFrame: Baseline up to 3 weeks
measure: Number of drop-outs from treatment
timeFrame: Baseline up to three weeks]
measure: Rates of inclusion to the study
timeFrame: Baseline
measure: Level of perceived socialm support measured by Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Baseline, post-treatment (immediately efter treatment completion)and at the 1, 3, 6 and 12-month follow up.
Locations:
city: Malmö
country: Sweden
facility: Traumamottagning Centrum för Sexuell Hälsa, Skånes Universitetssjukhus
Study officials:
affiliation: Karolinska Institutet
name: Maria Bragesjö, PhD
role: PRINCIPAL_INVESTIGATOR
References: