NCT06046586 Internet-Delivered Psychological Treatment for Cancer Survivors
| NCT ID | NCT06046586 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Cancer Survivors |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-04-10 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2025-04-10 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 substance use disorder, severe depression), or medical treatment (e.g., chemotherapy, immunotherapy, radiotherapy) that makes the treatment unfeasible * Other ongoing psychological treatment * Continuous psychotropic medication not stable for the past 4 weeks, or not expected to remain stable during the treatment period * Planned absence for more than one week of the intended treatment period * No complete the pre-treatment assessment
Contact & Investigator
Erland Axelsson, PhD
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT06046586 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer Survivors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06046586 currently recruiting?
Yes, NCT06046586 is actively recruiting participants. Contact the research team at erland.axelsson@ki.se for enrollment information.
Where is the NCT06046586 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT06046586 clinical trial?
NCT06046586 is sponsored by Karolinska Institutet. The principal investigator is Erland Axelsson, PhD at Karolinska Institutet. The trial plans to enroll 400 participants.
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