Feasibility of Cognitive Behavioural Therapy for Functional Memory Symptoms After Concussion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 20
- 主要终点
- Patient adherence
研究概览
简要总结
This study aims to evaluate the feasibility of novel cognitive behavioural therapy (CBT)-based intervention designed to improve functional memory symptoms after concussion. Participants will be randomized to CBT or an attention-matched control intervention (cognitive rehabilitation). The primary outcomes for this trial are feasibility metrics, including recruitment, patient-perceived credibility of treatment, patient adherence to treatment, therapists' compliance with the treatment protocol, and retention.
详细描述
Background: Although objectively measurable memory impairments typically resolve within weeks after sustaining a concussion, many people continue to perceive memory problems one year later. There are no known effective treatments for this condition. A promising new approach may be to target psychological mechanisms that perpetuate excessively negative perceptions of memory ability.
Methods: A pilot randomized controlled trial to evaluate the feasibility of a new cognitive behavioural therapy (CBT)-based treatment program specifically designed to improve persistent memory complaints after concussion. The main inclusion criteria will be (i) concussion in the past 6 to 24 months, (ii) research diagnosis of Functional Cognitive Disorder. Participants will be randomized (1:1) into one of two groups: CBT or cognitive rehabilitation. Individuals in both groups will participate in 11 x 50-minute sessions delivered over Zoom videoconference, co-facilitated by clinical psychology graduate students under the supervision of a registered clinical psychologist.
Aims: To evaluate the feasibility and potential efficacy of CBT for functional memory symptoms after concussion.
Approach: Prespecified feasibility criteria on recruitment, patient-perceived credibility of treatment, patient adherence to treatment, therapists' compliance with the treatment protocol, and retention will determine the success of the pilot trial. The investigators further hypothesize that CBT will be associated with greater reductions in memory concern compared to the control intervention.
Implications: The results of this pilot study will inform a larger, more definitive clinical trial focused on testing efficacy.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants will be blinded to their group assignment and treatment arms, but not to the type of intervention they are receiving. It is not possible to blind study therapists, as they have to administer the therapy.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old
- •Fluent in English
- •Have regular access to the internet
- •Sustained a concussion according to the World Health Organization Neurotrauma Task Force definition between 6 and 24 months ago
- •Meet diagnostic criteria for Functional Cognitive Disorder
排除标准
- •Performance validity test failure
- •Unstable/serious medical condition (e.g., cancer, multiple sclerosis, etc.),
- •Unstable severe/mental illness (e.g., schizophrenia requiring hospital admission in the past year)
- •Probable alcohol or drug use disorder
- •Taking a medication with a known side effect of memory impairment (e.g., benzodiazepines, opiates, or topiramate)
- •Contraindication(s) for MRI
结局指标
主要结局
Patient adherence
时间窗: Week 12
\>70% of participants attend at least 8 sessions
Therapists compliance
时间窗: Week 12
Therapists cover 95% of essential element content
Treatment credibility
时间窗: Week 2
\>50% of enrolled participants rate the intervention as above midpoint on credibility
Memory concern
时间窗: Week 12
Satisfaction subscale of the Multifactorial Memory Questionnaire \[range=0-72; higher scores indicate greater satisfaction with memory\]
Recruitment
时间窗: Week 0
\>50% of eligible participants agree to enroll
Retention
时间窗: Week 12
\>80% of randomized participants complete the primary outcome measure immediately post-intervention
次要结局
- Catastrophizing(Week 12)
- Reliance on others(Week 12)
- Patient Global Impression of Change(Week 12)
- Avoidance(Week 12)
研究者
Noah Silverberg
Principal Investigator
University of British Columbia