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Recruiting NCT06046586

Internet-Delivered Psychological Treatment for Cancer Survivors

Trial Parameters

Condition Cancer Survivors
Sponsor Karolinska Institutet
Study Type INTERVENTIONAL
Phase N/A
Enrollment 400
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-04-10
Completion 2029-12-31
Interventions
Support and informationBehavioral activationSystematic exposure with mindfulness training

Brief Summary

Negative psychological effects of cancer are common, but cancer survivors are rarely offered structured psychological treatment. Internet-delivered treatments have shown some promise, but specific treatment components have not been empirically evaluated which means that it is not clear which therapies that should be prioritized. In this randomized factorial trial at Karolinska Institutet, Stockholm, Sweden, 400 cancer survivors with psychiatric symptoms are enrolled in variations on a 10-week therapist-guided online psychological treatment intended to address the negative psychological long-term effects of cancer. The aim is to determine the contribution of treatment components to the overall effect.

Eligibility Criteria

Inclusion Criteria: * Cancer survivor at least 0.5 years after main therapy * Clinically significant anxiety or depression (Patient Health Questionnaire 9 \[PHQ-9\]≥10, or Generalized Anxiety Disorder 7 \[GAD-7\]≥8, or 9-item Fear of Cancer Recurrence Inventory \[FCRI-9\]≥16) * At least 18 years old * Resident of Region Stockholms, Västra Götalandsregionen, or Region Skåne, Sweden (listed and de facto) * Sufficient technical knowledge and knowledge of the Swedish language to take part in a text-based online treatment * Continuous access to an electronic device that can be used to access the study web platform Exclusion Criteria: * Recurrent thoughts of suicide, as based on clinical judgement aided by the structured interview and the self-report version of the Montgomery-Åsberg Depression Rating Scale (MADRS-S) item 9 * Severe medical condition (e.g., very poor prognosis, stage IV cancer), severe psychiatric disorder (e.g., psychotic disorder, bipolar disorder, or severely debilitating

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