Clinical trial · Interventional
Internet-based Support for Adjustment to Prostate Cancer
Internet-based Support for Adjustment to Prostate Cancer (ISAC) - A Randomized Controlled Trial of ICBT for Distress Related to Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Depression - Major Depressive Disorder | — | UNRESOLVED | — |
| Insomnia | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Psychological Distress | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Internet-based cognitive behavioral therapy | Behavioral | — | UNRESOLVED |
| Non-directive support | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tailored ICBT
- 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.
- interventionNames
- Behavioral: Internet-based cognitive behavioral therapy
- type
- ACTIVE_COMPARATOR
- label
- Non-directive support
- description
- The control group will receive weekly support via contact with a therapist, without receiving access to the treatment modules.
- interventionNames
- Behavioral: Non-directive support
Primary outcomes (1)
- measure
- Kessler-10 (K10)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available