Internet-Delivered Psychological Treatment for Cancer Survivors (IN-FACT-1)

Karolinska Institute

Status: Enrolling

Conditions: Cancer Survivors; Depression; Anxiety

Treatments: Behavioral: Systematic exposure with mindfulness training; Behavioral: Promotion of health behaviors; Behavioral: Support and information; Behavioral: Behavioral activation

Study type: Interventional

Funder types: Other

Identifiers

NCT06046586

2023-04056-01 #2

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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400 participants in 8 patient groups

Internet-delivered psychological treatment, arm #1

Experimental group

Description:

Support and information + Behavioral activation

Treatment:

Behavioral: Behavioral activation

Behavioral: Support and information

Internet-delivered psychological treatment, arm #2

Experimental group

Description:

Support and information + Systematic exposure with mindfulness training

Treatment:

Behavioral: Support and information

Behavioral: Systematic exposure with mindfulness training

Internet-delivered psychological treatment, arm #3

Experimental group

Description:

Support and information + Promotion of health behaviors

Treatment:

Behavioral: Support and information

Behavioral: Promotion of health behaviors

Internet-delivered psychological treatment, arm #4

Experimental group

Description:

Support and information + Behavioral activation + Systematic exposure with mindfulness training

Treatment:

Behavioral: Behavioral activation

Behavioral: Support and information

Behavioral: Systematic exposure with mindfulness training

Internet-delivered psychological treatment, arm #5

Experimental group

Description:

Support and information + Behavioral activation + Promotion of health behaviors

Treatment:

Behavioral: Behavioral activation

Behavioral: Support and information

Behavioral: Promotion of health behaviors

Internet-delivered psychological treatment, arm #6

Experimental group

Description:

Support and information + Systematic exposure with mindfulness training + Promotion of health behaviors

Treatment:

Behavioral: Support and information

Behavioral: Promotion of health behaviors

Behavioral: Systematic exposure with mindfulness training

Internet-delivered psychological treatment, arm #7

Experimental group

Description:

Support and information + Behavioral activation + Systematic exposure with mindfulness training + Promotion of health behaviors

Treatment:

Behavioral: Behavioral activation

Behavioral: Support and information

Behavioral: Promotion of health behaviors

Behavioral: Systematic exposure with mindfulness training

Internet-delivered psychological treatment, arm #8

Experimental group

Description:

Support and information

Treatment:

Behavioral: Support and information