Internet-based Support for Adjustment to Prostate Cancer

NCT ID: NCT06766526

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-05

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Psychological Distress Depression - Major Depressive Disorder Insomnia Anxiety Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

After recruitment finished, participants will be randomized to either tailored ICBT treatment or a control condition.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tailored ICBT

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.

Group Type EXPERIMENTAL

Internet-based cognitive behavioral therapy

Intervention Type BEHAVIORAL

An eight week ICBT treatment. The treatment is modular and tailored to the problem profile of the participant. One module will be administered every week during the treatment phase.

Non-directive support

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

Group Type ACTIVE_COMPARATOR

Non-directive support

Intervention Type BEHAVIORAL

Participants randomized to this condition will receive weekly support and contact with a therapist via the treatment platform. They will not have access to the treatment modules during the treatment phase.

Interventions

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Internet-based cognitive behavioral therapy

An eight week ICBT treatment. The treatment is modular and tailored to the problem profile of the participant. One module will be administered every week during the treatment phase.

Intervention Type BEHAVIORAL

Non-directive support

Participants randomized to this condition will receive weekly support and contact with a therapist via the treatment platform. They will not have access to the treatment modules during the treatment phase.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Linkoeping

OTHER

Sponsor Role collaborator

Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Gerhard Andersson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gerhard Andersson, pHD

Role: PRINCIPAL_INVESTIGATOR

Linkoeping University

Locations

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Department of Behavioral Sciences and Learning

Linköping, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Gerhard Andersson, Ph.D.

Role: CONTACT

+46-13285840

Anton Käll, Ph.D.

Role: CONTACT

Facility Contacts

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Gerhard Andersson, Ph.D.

Role: primary

+46-13285840

Related Links

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https://www.iterapi.se/sites/isac/

Website used for the treatment.

Other Identifiers

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ISAC

Identifier Type: -

Identifier Source: org_study_id

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