Waking Hypnosis in the Treatment of MS-related Fatigue: Pilot and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Fatigue Self Efficacy
研究概览
简要总结
The proposed study is a single-center, single-blind three-group randomized (1:1:1) controlled trial (RCT) comparing two hypnosis interventions to waitlist control efficacy for MS-related fatigue.
详细描述
This project will test the efficacy of two different hypnosis approaches for improving MS-related fatigue that have shown to be beneficial for individuals with cancer and other medical conditions in the management of their symptoms. One of these methods, the active-alert hypnosis has helped people to manage fatigue and may have important advantages over the more traditional relaxation hypnotic approaches in the treatment of fatigue, since the hypnotic inductions and the self-hypnosis methods use activation instead of relaxation. Therefore, the goals of this study are to determine if a comparison study of these two hypnotic conditions is feasible, and, if so, to determine which treatment may be more effective for helping individuals with MS gain more control over fatigue. Additionally, it will explore the mechanisms of these two approaches to hypnosis treatment to determine which might be most helpful to individuals with MS and fatigue.
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
- Single (Outcomes Assessor)
盲法说明
Research assistant administering the telephone assessments is blinded to participant treatment intervention while the clinician conducting the treatment sessions is blinded to participant responses provided during telephone assessments. The only instance where we may unblind staff members to assessment or treatment data (depending on what the staff member is responsible for) will be at the end of the study, after data collection has been completed. At that point, the staff member conducting telephone assessments may be allowed to know which interventions participants were assigned to, and the clinician conducting treatment sessions may be allowed to access assessment data if a staff member were to assist in data cleaning or data analysis. Participants are blind to study hypotheses and will not be told which intervention is expected to yield what results. Participants may be unblinded if/when we disseminate findings (e.g., in a published manuscript) related to this study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MS;
- •Adults 18 years of age or older;
- •Bothersome fatigue (defined as the presence of chronic, problematic fatigue that, in the opinion of the patient, has interfered with their daily activities for ≥ 3 months and average Fatigue Severity Scale score > to 4 at screening);
- •Ability to read, speak, and understand English and/or Spanish.
排除标准
- •Exclusion criteria will be evidence for significant psychopathology that would interfere with study participation, including current suicidal ideation with intent, active psychosis or hallucinations, or severe cognitive impairment.
研究组 & 干预措施
Active-Alert Hypnosis
干预措施: Active-Alert Hypnosis (Behavioral)
Traditional Hypnosis
干预措施: Traditional Hypnosis (Behavioral)
Wait-List Control
Participants in this arm will continue their usual care for fatigue. The therapist will notify participants assigned to Usual Care via the participant's preferred mode of communication (phone, U.S. mail, or email). People assigned to usual care will be encouraged to continue using the health care services available to them to address their fatigue. The study therapist will emphasize the importance of completing the outcome assessments. Following the completion of their final assessment (3 month follow-up); these individuals will be offered their choice of the two hypnosis treatments.
结局指标
主要结局
Fatigue Self Efficacy
时间窗: 4 months: 3 month follow-up
Multiple Sclerosis-Fatigue Self-Efficacy scale
Fatigue Severity
时间窗: 4 months: 3 month follow-up
Fatigue Severity Scale (FSS) score
Fatigue Self Efficacy
时间窗: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Multiple Sclerosis-Fatigue Self-Efficacy scale
Fatigue Self Efficacy
时间窗: Third week: mid-treatment (after second session)
Multiple Sclerosis-Fatigue Self-Efficacy scale
Fatigue Self Efficacy
时间窗: Fifth week: post-treatment (after fourth session)
Multiple Sclerosis-Fatigue Self-Efficacy scale
Fatigue Severity
时间窗: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Fatigue Severity Scale (FSS) score
Fatigue Severity
时间窗: Third week: mid-treatment (after second session)
Fatigue Severity Scale (FSS) score
Fatigue Severity
时间窗: Fifth week: post-treatment (after fourth session)
Fatigue Severity Scale (FSS) score
次要结局
- Psychological and Physical Function(4 months: 3 month follow-up)
- Sleep Quality(4 months: 3 month follow-up)
- Attitudes towards hypnosis(4 months: 3 month follow-up)
- Illness Perception(4 months: 3 month follow-up)
- Activity Level(4 months: 3 month follow-up)
- Suggestibility(Fifth week: post-treatment (after fourth session))
- Treatment Outcome Expectancy(Assessed via telephone within a 1-week period at baseline (prior to randomization))
- Psychological and Physical Function(Assessed via telephone within a 1-week period at baseline (prior to randomization))
- Psychological and Physical Function(Third week: mid-treatment (after second session))
- Psychological and Physical Function(Fifth week: post-treatment (after fourth session))
- Activity Level(Assessed via telephone within a 1-week period at baseline (prior to randomization))
- Activity Level(Third week: mid-treatment (after second session))
- Activity Level(Fifth week: post-treatment (after fourth session))
- Suggestibility(Within a 1-week period at baseline (prior to randomization))
- Attitudes towards hypnosis(Assessed via telephone within a 1-week period at baseline (prior to randomization))
- Illness Perception(Third week: mid-treatment (after second session))
- Attitudes towards hypnosis(Third week: mid-treatment (after second session))
- Attitudes towards hypnosis(Fifth week: post-treatment (after fourth session))
- Sleep Quality(Assessed via telephone within a 1-week period at baseline (prior to randomization))
- Sleep Quality(Third week: mid-treatment (after second session))
- Sleep Quality(Fifth week: post-treatment (after fourth session))
- Illness Perception(Assessed via telephone within a 1-week period at baseline (prior to randomization))
- Illness Perception(Fifth week: post-treatment (after fourth session))
研究者
M. Elena Mendoza
Principal Investigator
University of Washington