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NCT Number: NCT06318195

Condensed Digital 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Universitetssjukhuset; Tema Kvinnohälsa och Hälsoprofessioner; Medicinsk Enhet Medicinsk Psykologi; Sektion Beteendemedicin

Stockholm, Sweden

Location contact

Charlotte Gentili, PhD

CONTACT

[email protected]

+46760482895

Mike Kemani, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Condensed Internet delivered prolonged exposure (CIPE)

Behavioral

Condensed Internet delivered prolonged exposure (CIPE) with therapist support for three weeks.

Primary outcomes

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

    Time frame: 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.

    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.

Secondary outcomes

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

    Time frame: 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.

    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.

  2. Change in psychosocial impairment measured by The Work and Social Adjustment Scale (WSAS), adapted to symptoms of post-traumatic stress.

    Time frame: 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.

    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.

Other outcomes

  1. Participants satisfaction with treatment.

    Time frame: Immediately after treatment completion.

    Qualitative questions pertaining participants satisfaction with the treatment.

  2. Adverse events related to treatment.

    Time frame: Immediately after treatment completion.

    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.

  3. Number of completed treatment modules

    Time frame: Baseline up to 3 weeks

    Data will be gathered on total number of completed modules during the three week treatment.

  4. Number of messages sent and received in the digital platform

    Time frame: Baseline up to 3 weeks

    Data will be gathered on total number of messages sent and received in the digital platform during the three week treatment.

  5. Number of completed home work assignments by the participant during the treatment period

    Time frame: Baseline up to 3 weeks

    Data will be gathered on total number of completed home work assignments by the participant during the three week treatment.

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

    Time frame: Baseline up to 6 months

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

  7. The proportion of participants that go through the entire treatment period

    Time frame: Baseline up to three weeks

    The proportion of participants that go through the entire treatment period

  8. Number of drop-outs from treatment

    Time frame: Baseline up to three weeks

    Number of drop-outs from treatment

  9. Rates of inclusion to the study

    Time frame: Baseline

    Data on rates of inclusion will be considered as an indication of the feasibility of the intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Bragesjö, PhD

CONTACT

[email protected]

+46703399387

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital

Registry information

Official study title

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

Acronym: CiPE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2024
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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