Online support for men adjusting to prostate cancer
Internet-based Support for Adjustment to Prostate Cancer (ISAC) - A Randomized Controlled Trial of ICBT for Distress Related to Prostate Cancer
This study is testing if an online therapy program can help men dealing with emotional challenges after being diagnosed with prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Linkoeping University Government |
| Locations | 1 site (Linköping) |
| Trial ID | NCT06766526 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of internet-based cognitive behavior therapy (ICBT) in alleviating psychological distress and related psychiatric symptoms in men diagnosed with prostate cancer. Participants will be randomly assigned to either an eight-week tailored ICBT intervention or an attention control group, both receiving weekly support from a trained therapist. The primary focus is on reducing psychological distress, with additional health-related outcomes also being assessed. Recruitment will take place across Sweden, targeting men who are not currently undergoing medical treatment for prostate cancer.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 or older who have been diagnosed with prostate cancer and are experiencing psychological symptoms related to their diagnosis.
Not a fit: Patients currently undergoing medical treatment for prostate cancer or those with severe psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental health and quality of life for men coping with prostate cancer.
How similar studies have performed: Previous studies have shown that internet-based cognitive behavioral therapy can be effective for various psychological issues, suggesting potential success for this tailored approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Linköping
- Department of Behavioral Sciences and Learning — Linköping, Sweden (Recruiting)
Study contacts
- Principal investigator: Gerhard Andersson, pHD — Linkoeping University
- Study coordinator: Gerhard Andersson, Ph.D.
- Email: gerhard.andersson@liu.se
- Phone: +46-13285840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.