Internet-based Support for Adjustment to Prostate Cancer

NCT06766526 | Recruiting

• 1 other identifier: ISAC
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Distress; Depression - Major Depressive Disorder; Insomnia; Anxiety; Prostate Cancer

Keywords

Psychological distress; Prostate cancer; Cancer; ICBT; Cognitive behavior therapy

Outcome Measures

Primary Outcomes (1)

• Kessler-10 (K10)

  Measure of psychological distress. Consists of 10 items. Higher scores indicate greater psychological distress. Scores can range between 10 and 50.

  At pretreatment, weekly during the treatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.

Secondary Outcomes (6)

• Fear of Cancer Recurrence Inventory, short form (FCRI)

  At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.

• Generalized Anxiety Disorder-7 item scale (GAD-7)

  At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.

• Insomnia Severity Index (ISI)

  At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.

• Brunnsviken Brief Quality of Life Scale (BBQ)

  At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.

• The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)

  At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.

Other Outcomes (1)

• Client Satisfaction Questionnaire-8 item version (CSQ-8)

  Measured after nine weeks of treatment.

Study Arms (2)

Tailored ICBT

EXPERIMENTAL

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.

Behavioral: Internet-based cognitive behavioral therapy

Non-directive support

ACTIVE COMPARATOR

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

Behavioral: Non-directive support

Interventions

Internet-based cognitive behavioral therapy 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.

Tailored ICBT

Non-directive support 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.

Non-directive support

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Linkoeping University: lead
• University Hospital, Linkoeping: collaborator

Study Sites (1)

Department of Behavioral Sciences and Learning

Linköping, 58183, Sweden

RECRUITING

Related Links

• Website used for the treatment.

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Gerhard Andersson, pHD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerhard Andersson, Ph.D.

CONTACT

+46-13285840; gerhard.andersson@liu.se

Anton Käll, Ph.D.

CONTACT

anton.kall@liu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: After recruitment finished, participants will be randomized to either tailored ICBT treatment or a control condition.

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 9, 2025
• Study Start: January 5, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

SE (1)