Internet-based Support for Adjustment to Prostate Cancer

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Kessler-10 (K10) [Срок оценки: At pretreatment, weekly during the treatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.]

Вторичные конечные точки (6)

• Fear of Cancer Recurrence Inventory, short form (FCRI) [Срок оценки: 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) [Срок оценки: At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.]
• Insomnia Severity Index (ISI) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.]
• The Illness Cognition Questionnaire (ICQ) [Срок оценки: At pretreatment, weekly during the treatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швеция · 1 центр

• Department of Behavioral Sciences and Learning — Linköping

Идентификаторы

NCT: NCT06766526 · ISAC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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