Internet-based Support for Adjustment to Prostate Cancer (ISAC) - A Randomized Controlled Trial of ICBT for Distress Related to Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Kessler-10 (K10)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Kessler-10 (K10)
时间窗: 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.
次要结局
- 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.)
- The Illness Cognition Questionnaire (ICQ)(At pretreatment, weekly during the treatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.)
研究者
Gerhard Andersson
Professor
Linkoeping University