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NCT Number: NCT06766526

Internet-based Support for Adjustment to Prostate Cancer

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.

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Key information

Conditions

Psychological Distress Anxiety Anxiety Disorders Depression - Major Depressive Disorder Dyssomnias Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Insomnia Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Prostate Cancer Prostatic Diseases Prostatic Neoplasms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Behavioral Sciences and Learning

Linköping, 58183, Sweden

Location status: Recruiting

Location contact

Anton Käll, Ph.D.

SUB_INVESTIGATOR

Gerhard Andersson, Ph.D.

CONTACT

[email protected]

+46-13285840

Gerhard Andersson, Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Kessler-10 (K10)

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

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

Secondary outcomes

  1. Fear of Cancer Recurrence Inventory, short form (FCRI)

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

    Measure of fear of the cancer recurring and/or spreading. Consists of 9 items. Higher scores indicate greater fear/anxiety levels. Scores can range between 0 and 36.

  2. Generalized Anxiety Disorder-7 item scale (GAD-7)

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

    Measure of symptoms of generalized anxiety disorder. Consists of seven items. Higher scores indicate greater anxiety. Scores can range between 0 and 21.

  3. Insomnia Severity Index (ISI)

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

    Measure of insomnia and sleep related-difficulties. Consists of seven items. Higher scores indicate greater sleep related-difficulties. Scores can range from 0 to 28.

  4. Brunnsviken Brief Quality of Life Scale (BBQ)

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

    Measure of quality of life. Consists of 12 items. Higher scores indicate a greater quality of life. Scores can range between 0 and 96.

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

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

    Measure of health-related quality of life. Consists of 30 items and three main subscales which each will serve as an outcome: Global health status, Functional status, and Symptom status. Higher scores indicate a greater health status within the domain. Scores can range between 0 and 100.

  6. The Illness Cognition Questionnaire (ICQ)

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

    Measure of cognitions about the illness (in this case prostate cancer). Consists of 18 items. Analyzed separately as three subscales: Acceptance, Perceived benefits, and Helplessness. Greater scores indicate greater acceptance, more perceived benefits, and greater helplessness, respectively. Will also be used as mediators in a mediation analysis with the rate of change in subscale sum scores used as mediators. Sum scores for each subscale can range between 6 and 24.

Other outcomes

  1. Client Satisfaction Questionnaire-8 item version (CSQ-8)

    Time frame: Measured after nine weeks of treatment.

    Measure of treatment satisfaction. Consists of eight items. Higher scores indicate greater treatment satisfaction. Scores can range between 8 and 32.

Study contacts

Contact information is provided by the study sponsor or research team.

Anton Käll, Ph.D.

CONTACT

[email protected]

Gerhard Andersson, Ph.D.

CONTACT

[email protected]

+46-13285840

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Collaborators

  • University Hospital, Linkoeping

Registry information

Official study title

Internet-based Support for Adjustment to Prostate Cancer (ISAC) - A Randomized Controlled Trial of ICBT for Distress Related to Prostate Cancer

Acronym: ISAC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2025
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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