About this trial
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
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Support and information
- Behavioral activation
- Systematic exposure with mindfulness training
- Promotion of health behaviors
Treatment groups
8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Karolinska Institutet
Lead sponsor
Region Stockholm
Collaborator