Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors
NCT ID: NCT06046573
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2024-03-10
2024-10-22
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Internet-delivered psychological treatment, arm #1
Support and information + Behavioral activation
Support and information
Emotional and technical support. Information about the long-term effects of cancer.
Behavioral activation
Behavioral activation with existential themes and emphasis on values and relationships.
Internet-delivered psychological treatment, arm #2
Support and information + Systematic exposure with mindfulness training
Support and information
Emotional and technical support. Information about the long-term effects of cancer.
Systematic exposure with mindfulness training
Systematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma.
Internet-delivered psychological treatment, arm #3
Support and information + Promotion of health behaviors
Support and information
Emotional and technical support. Information about the long-term effects of cancer.
Promotion of health behaviors
An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.
Internet-delivered psychological treatment, arm #4
Support and information + Behavioral activation + Systematic exposure with mindfulness training
Support and information
Emotional and technical support. Information about the long-term effects of cancer.
Behavioral activation
Behavioral activation with existential themes and emphasis on values and relationships.
Systematic exposure with mindfulness training
Systematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma.
Internet-delivered psychological treatment, arm #5
Support and information + Behavioral activation + Promotion of health behaviors
Support and information
Emotional and technical support. Information about the long-term effects of cancer.
Behavioral activation
Behavioral activation with existential themes and emphasis on values and relationships.
Promotion of health behaviors
An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.
Internet-delivered psychological treatment, arm #6
Support and information + Systematic exposure with mindfulness training + Promotion of health behaviors
Support and information
Emotional and technical support. Information about the long-term effects of cancer.
Systematic exposure with mindfulness training
Systematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma.
Promotion of health behaviors
An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.
Internet-delivered psychological treatment, arm #7
Support and information + Behavioral activation + Systematic exposure with mindfulness training + Promotion of health behaviors
Support and information
Emotional and technical support. Information about the long-term effects of cancer.
Behavioral activation
Behavioral activation with existential themes and emphasis on values and relationships.
Systematic exposure with mindfulness training
Systematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma.
Promotion of health behaviors
An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.
Internet-delivered psychological treatment, arm #8
Support and information
Support and information
Emotional and technical support. Information about the long-term effects of cancer.
Interventions
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Support and information
Emotional and technical support. Information about the long-term effects of cancer.
Behavioral activation
Behavioral activation with existential themes and emphasis on values and relationships.
Systematic exposure with mindfulness training
Systematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma.
Promotion of health behaviors
An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.
Eligibility Criteria
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Inclusion Criteria
* 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 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
* 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
18 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Erland Axelsson
Principal Investigator
Principal Investigators
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Erland Axelsson, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Karolinska Institutet
Stockholm, , Sweden
Countries
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References
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Winter J, Gasslander N, Rane G, Sundstrom F, Bjorkhem-Bergman L, Hedman C, Axelsson E. Proof-of-concept for a randomized factorial design strategy to build a complex online support program for cancer survivors with psychiatric symptoms: the IN-FACT-0 feasibility trial. J Cancer Surviv. 2025 Oct 25. doi: 10.1007/s11764-025-01905-2. Online ahead of print.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2023-04056-01 #1
Identifier Type: -
Identifier Source: org_study_id