Randomized Factorial Trial of Internet-Delivered Psychological Treatment for Cancer Survivors With Clinically Significant Psychiatric Symptoms
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cancer Survivors
- Sponsor
- Karolinska Institutet
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- General anxiety
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
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.
Investigators
Erland Axelsson
Principal Investigator
Karolinska Institutet
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
Outcomes
Primary Outcomes
General anxiety
Time Frame: Pre-treatment (within 2 weeks before treatment), via weekly assessments, to post-treatment (after treatment, completed within 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).
General Anxiety Disorder 7 (GAD-7, theoretical range: 0-21, where a higher score indicates more general anxiety). The phrasing is revised to concern the past week. The conventional version is also administered at screening (within 6 months before treatment), used to inform the eligibility assessment and to describe the sample.
Depressive symptoms
Time Frame: Pre-treatment (within 2 weeks before treatment), via weekly assessments, to post-treatment (after treatment, completed within 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).
Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, where a higher score indicates more symptoms of depression). The phrasing is revised to concern the past week. The conventional version is also administered at screening (within 6 months before treatment), used to inform the eligibility assessment and to describe the sample.
Fear of cancer recurrence
Time Frame: Pre-treatment (within 2 weeks before treatment), via weekly assessments, to post-treatment (after treatment, completed within 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).
9-item Fear of Cancer Recurrence Inventory (FCRI-9, theoretical range: 0-36, where a higher score indicates a more pronounced fear of cancer recurrence). This scale is also administered at screening (within 6 months before treatment), used to inform the eligibility assessment and to describe the sample.
Secondary Outcomes
- Health anxiety(Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).)
- Disability(Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).)
- Somatic symptom burden(Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).)
- Body image distress(Screening (within 6 months before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days))
- Treatment credibility and patient expectancy of improvement(Week 2 of treatment)
- Relationship with the therapist (therapeutic alliance)(Week 2 of treatment)
- Patient satisfaction with treatment(Post-treatment assessment (immediately after treatment, completed within 90 days))
- Adverse events(Post-treatment assessment (immediately after treatment, completed within 90 days))
- Perceived negative effects of treatment(Post-treatment assessment (immediately after treatment, completed within 90 days))
- Lifestyle behaviors(Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days).)