Internet-based Support for Adjustment to Prostate Cancer (ISAC)

Linköping University (LiU)

Status: Enrolling

Conditions: Insomnia; Anxiety; Prostate Cancer; Depression - Major Depressive Disorder; Psychological Distress

Treatments: Behavioral: Internet-based cognitive behavioral therapy; Behavioral: Non-directive support

Study type: Interventional

Funder types: Other

Identifiers

NCT06766526

ISAC

Details and patient eligibility

About

The study aims to study the efficacy of internet-based cognitive behavior therapy (ICBT) in reducing subjective distress and comorbid psychiatric symptoms in men diagnosed with prostate cancer. Participants who have been diagnosed with prostate cancer and are currently not undergoing or scheduled to undergo medical treatment will be recruited. Once recruited, they will be randomized to receive either a tailored, eight-week long ICBT intervention or an attention control group. Both group receive weekly support by a trained therapist.

Full description

Men diagnosed with prostate cancer frequently suffer from a wide range of psychological problems that can be traced to their disorder. Examples include depressed mood and worry regarding the prognosis and/or cancer recurrence. Psychological treatments can be used for helping cancer patients deal with this kind of distress, but frequently only targets one kind of symptoms.

This study investigates a tailored approach to providing help for men diagnosed with prostate cancer. Participants randomized to the treatment condition will receive an eight week ICBT intervention which is tailored to the problem profile of the participant in question. The treatment will last eight weeks and participants will receive weekly support and feedback from a therapist. Participants randomized to the control condition will receive weekly therapist support, but not access to the treatment modules. The primary outcome of interest is psychological distress, and other health-related outcomes will be measured as well. Participants will be recruited in Sweden with a nationwide recruitment.

Enrollment: 180 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjectively reported psychological symptoms and problems that have come about after a prostate cancer diagnosis.
• A sum score above 19 on the primary outcome measure (Kessler-10).
• An age of 18 or older.
• Ability to speak, read, and write Swedish.
• Access to a computer/laptop/tablet/smartphone and internet access.
• Sufficient computer profiency to be able to use the treatment platform.

Exclusion criteria

• Planned medical treatment or planned change in medication related to the prostate cancer during the treatment period.
• Recently finished (within the past six months) medical treatment for prostate cancer.
• Severe psychiatric or somatic conditions that impedes participation in the study.
• Ongoing substance use problems.
• Acute suicidality.
• Other ongoing psychological treatment.
• Psychopharmaceutic treatment that has been changed within the past month or with planned changes during the treatment phase.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Tailored ICBT

Experimental group

Description:

An eight week long ICBT treatment that is tailored to the problem profile of the participant. The treatment is modular, with one module being administered per week of the treatment.

Treatment:

Behavioral: Internet-based cognitive behavioral therapy

Non-directive support

Active Comparator group

Description:

The control group will receive weekly support via contact with a therapist, without receiving access to the treatment modules.

Treatment:

Behavioral: Non-directive support