Clinical trial NCT06766526: Internet-based Support for Adjustment to Prostate Cancer
Official title: Internet-based Support for Adjustment to Prostate Cancer (ISAC) - A Randomized Controlled Trial of ICBT for Distress Related to Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychological Distress
Depression - Major Depressive Disorder
Insomnia
Anxiety
Prostate Cancer
Keywords: Psychological distress
Prostate cancer
Cancer
ICBT
Cognitive behavior therapy
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: University Hospital, Linkoeping
First posted: 2025-01-09
Enrollment: 180
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After recruitment finished, participants will be randomized to either tailored ICBT treatment or a control condition.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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.

Primary outcomes:
measure: Kessler-10 (K10)
timeFrame: At pretreatment, weekly during the treatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
Secondary outcomes:
measure: Fear of Cancer Recurrence Inventory, short form (FCRI)
timeFrame: At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
measure: Generalized Anxiety Disorder-7 item scale (GAD-7)
timeFrame: At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
measure: Insomnia Severity Index (ISI)
timeFrame: At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
measure: Brunnsviken Brief Quality of Life Scale (BBQ)
timeFrame: At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
measure: The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)
timeFrame: At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
measure: The Illness Cognition Questionnaire (ICQ)
timeFrame: At pretreatment, weekly during the treatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
Other outcomes:
measure: Client Satisfaction Questionnaire-8 item version (CSQ-8)
timeFrame: Measured after nine weeks of treatment.
Locations:
city: Linköping
country: Sweden
facility: Department of Behavioral Sciences and Learning
Study officials:
affiliation: Linkoeping University
name: Gerhard Andersson, pHD
role: PRINCIPAL_INVESTIGATOR
References: