Internet-based Support for Adjustment to Prostate Cancer

NCT06766526 · Linkoeping University

Recruiting

In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title

Internet-based Support for Adjustment to Prostate Cancer (ISAC) - A Randomized Controlled Trial of ICBT for Distress Related to Prostate Cancer

About this study

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.

Eligibility criteria

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.

Study design

Enrollment target: 180 participants

Allocation: randomized

Masking: none

Age groups: adult, older_adult

Timeline

Starts: 2025-01-05

Estimated completion: 2026-12

Last updated: 2025-02-24

Interventions

Behavioral: Internet-based cognitive behavioral therapyBehavioral: Non-directive support

Primary outcomes

• Kessler-10 (K10) (At pretreatment, weekly during the treatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.)

Sponsor

Linkoeping University · other_gov

With: University Hospital, Linkoeping

Contacts & investigators

ContactGerhard Andersson, Ph.D. · contact · gerhard.andersson@liu.se · +46-13285840

ContactAnton Käll, Ph.D. · contact · anton.kall@liu.se

InvestigatorGerhard Andersson, pHD · principal_investigator, Linkoeping University

All locations (1)

Department of Behavioral Sciences and LearningRecruiting

Linköping, Sweden

View on ClinicalTrials.gov ↗Find similar trials