A Pragmatic Pilot Study of Cognitive Behavioural Therapy for Insomnia Among People Living With HIV
2019年8月12日 更新者:Tyler Tulloch、Ryerson University
Insomnia is a problem for approximately 75% of people living with HIV, which is much higher than the 6% to 10% of people with insomnia in the general population.
It is currently unknown why the rate of insomnia is so high among people living with HIV, and because of this, they are often excluded from clinical trials examining the usefulness of cognitive behavioural therapy for insomnia (CBT-I), which is recommended as the first-line treatment for insomnia.
Insomnia is also associated with poorer immune functioning and lower medication adherence.
The purpose of this study is to examine whether CBT-I is useful at reducing insomnia among people living with HIV, and to examine whether this counselling is safe to provide to this population.
Other purposes are to explore whether reducing insomnia will lead to improved immune functioning and medication adherence, to collect feedback about people's experiences receiving CBT-I, to examine which psychological and behavioural factors are associated with insomnia severity among people living with HIV.
研究概览
详细说明
The prevalence of insomnia in the general population ranges from 6% to 10% (American Psychiatric Association, 2013), whereas its estimated prevalence among people living with HIV (PWH) is 73% (Rubinstein & Selwyn, 1998).
Cognitive, behavioural, physiological, and psychosocial explanations for this elevated prevalence have been proposed (Taibi, 2013), however, there is a lack of consensus in the literature.
Sleep disturbance is associated with disrupted immune functioning at the cellular level (Taylor, Lichstein, & Durrence, 2003), as well as increased risk of contracting infectious diseases (Patel et al., 2012); therefore, insomnia may be particularly problematic for PWH.
Cognitive behavioural therapy for insomnia (CBT-I; Edinger & Carney, 2008) is the first-line treatment for insomnia (Qaseem et al., 2016; Schutte-Rodin et al., 2008), and medium to large effect sizes have been reported (Okajima et al., 2011).
CBT-I is effective at treating insomnia among individuals with comorbid medical disorders such as chronic pain (Jungquist et al., 2012), fibromyalgia (Martínez et al., 2014), and cancer (Garland et al., 2014).
Surprisingly, no study to date has examined the efficacy of CBT-I among PWH.
The current study will evaluate the safety, feasibility, acceptability, and effects of CBT-I among 20 PWH using a pragmatic pilot study design.
An exit interview will be conducted to elicit participant feedback about the treatment and methods used.
Additional cross-sectional analyses will examine predictors of insomnia symptom severity and other sleep-related outcomes among a larger sample (n = 60).
This will be the first study to examine the impact of CBT-I among PWH.
研究类型
介入性
注册 (实际的)
10
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Ontario
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Toronto、Ontario、加拿大、M5B 2K3
- Department of Psychology, Ryerson University
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 18 years of age or older
- able to understand and communicate in English
- capable of providing informed consent
- presence of insomnia based on screener questionnaire cutoff score ≥ 15 on the Insomnia Severity Index
- HIV-seropositive
- willing to provide HIV viral load and CD4 count from blood work within the past two months
Exclusion Criteria:
- active suicidal ideation
- psychotic symptoms
- unmanaged bipolar disorder
- presence of a severe alcohol or substance use disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria
- hypnotic dependence
- presence of any breathing-related sleep disorders (obstructive sleep apnea hypopnea, central sleep apnea, and sleep-related hypoventilation), or circadian rhythm sleep-wake disorders
- working shift work or frequent time zone travel over the course of the study
- contingent or inconsistent hypnotic use, or anticipated change in hypnotic medication dose over the course of the study
- receiving psychotherapy for insomnia or any other mental disorder over the course of the study
- presence of an AIDS-defining opportunistic infection and/or a CD4 count < 200
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:CBT-I
This is a single arm study in which all participants receive the intervention (cognitive behavioural therapy for insomnia)
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Cognitive behavioural therapy for insomnia (CBT-I; Edinger & Carney, 2008) is a standard 4-session cognitive behavioural therapy for insomnia administered biweekly in individual format.
The first session involves presenting treatment rationale and introducing a behavioural treatment regimen consisting of a series of sleep habit parameters to follow, and determining a personalized "time in bed" prescription.
The second session involves reviewing past-week sleep diary, discussing the role of cognitions in insomnia, and discussing constructive worrying techniques and the use of thought records.
The third and fourth sessions are used to assist in adjusting "time in bed" prescriptions, to positively reinforce efforts, and to help problem-solve any problems they might have encountered.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Insomnia symptom severity
大体时间:Two weeks post-treatment
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Insomnia symptom severity is measured using the Insomnia Severity Index (ISI)
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Two weeks post-treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
CD4+ (cluster of differentiation 4) cell count
大体时间:Within two months post-treatment
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Obtained via self-report based on blood test results in past 3 months
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Within two months post-treatment
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HIV viral load
大体时间:Within two months post-treatment
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Obtained via self-report based on blood test results in past 3 months
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Within two months post-treatment
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Combined antiretroviral therapy (cART) medication adherence
大体时间:Two weeks post-treatment
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Measured using the Self-Rating Scale Item (SRSI) and Simplified Medication Adherence Questionnaire (SMAQ)
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Two weeks post-treatment
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Sleep efficiency
大体时间:Two weeks post-treatment
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Sleep efficiency is the amount of time spent sleeping vs. awake in bed
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Two weeks post-treatment
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Total wake time
大体时间:Two weeks post-treatment
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Total wake time is the total time spent awake between getting into bed at night
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Two weeks post-treatment
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Health-related quality of life
大体时间:Two weeks post-treatment
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Measured using the Medical Outcomes Study Short-Form Health Survey (SF-36)
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Two weeks post-treatment
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Depression symptom severity
大体时间:Two weeks post-treatment
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Measured using the Centre for Epidemiological Studies in Depression Scale-Revised (CESD-R) and Depression Anxiety Stress Scales (DASS-21)
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Two weeks post-treatment
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Treatment acceptability
大体时间:Immediately post-treatment (final therapy session)
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Measured using the Therapy Evaluation Questionnaire (TEQ)
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Immediately post-treatment (final therapy session)
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Intervention safety
大体时间:Two weeks post-treatment
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Measured via qualitative exit interview, and includes any unwanted or adverse events associated with the intervention
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Two weeks post-treatment
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Dysfunctional beliefs about sleep
大体时间:Two weeks post-treatment
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Measured using the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16)
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Two weeks post-treatment
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Sleep effort
大体时间:Two weeks post-treatment
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Measured using the Glasgow Sleep Effort Scale (GSES)
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Two weeks post-treatment
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Self-efficacy for sleep
大体时间:Two weeks post-treatment
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Measured using the Self-Efficacy for Sleep Scale (SE-S)
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Two weeks post-treatment
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Pre-sleep arousal
大体时间:Two weeks post-treatment
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Measured using the Pre-Sleep Arousal Scale (PSAS-13)
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Two weeks post-treatment
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Fatigue
大体时间:Two weeks post treatment
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Measured using the Fatigue Severity Scale (FSS)
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Two weeks post treatment
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Anxiety Symptom Severity
大体时间:Two weeks post treatment
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Measured using the Depression Anxiety Stress Scales (DASS-21)
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Two weeks post treatment
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HIV-Related Fatigue
大体时间:Two weeks post treatment
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Measured using the HIV-Related Fatigue Scale (HRFS)
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Two weeks post treatment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Tyler Tulloch, MA、Ryerson University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Garland SN, Johnson JA, Savard J, Gehrman P, Perlis M, Carlson L, Campbell T. Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients. Neuropsychiatr Dis Treat. 2014 Jun 18;10:1113-24. doi: 10.2147/NDT.S47790. eCollection 2014.
- Jungquist CR, Tra Y, Smith MT, Pigeon WR, Matteson-Rusby S, Xia Y, Perlis ML. The durability of cognitive behavioral therapy for insomnia in patients with chronic pain. Sleep Disord. 2012;2012:679648. doi: 10.1155/2012/679648. Epub 2012 Aug 9.
- Martinez MP, Miro E, Sanchez AI, Diaz-Piedra C, Caliz R, Vlaeyen JW, Buela-Casal G. Cognitive-behavioral therapy for insomnia and sleep hygiene in fibromyalgia: a randomized controlled trial. J Behav Med. 2014 Aug;37(4):683-97. doi: 10.1007/s10865-013-9520-y. Epub 2013 Jun 7.
- Patel SR, Malhotra A, Gao X, Hu FB, Neuman MI, Fawzi WW. A prospective study of sleep duration and pneumonia risk in women. Sleep. 2012 Jan 1;35(1):97-101. doi: 10.5665/sleep.1594.
- Qaseem A, Kansagara D, Forciea MA, Cooke M, Denberg TD; Clinical Guidelines Committee of the American College of Physicians. Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016 Jul 19;165(2):125-33. doi: 10.7326/M15-2175. Epub 2016 May 3.
- Rubinstein ML, Selwyn PA. High prevalence of insomnia in an outpatient population with HIV infection. J Acquir Immune Defic Syndr Hum Retrovirol. 1998 Nov 1;19(3):260-5. doi: 10.1097/00042560-199811010-00008.
- Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008 Oct 15;4(5):487-504.
- Taibi DM. Sleep disturbances in persons living with HIV. J Assoc Nurses AIDS Care. 2013 Jan-Feb;24(1 Suppl):S72-85. doi: 10.1016/j.jana.2012.10.006.
- Taylor DJ, Lichstein KL, Durrence HH. Insomnia as a health risk factor. Behav Sleep Med. 2003;1(4):227-47. doi: 10.1207/S15402010BSM0104_5.
- Edinger JD, Carney, CE. Overcoming insomnia: A cognitive-behavioral therapy approach. Therapist Guide. New York: Oxford University Press, 2008.
- Okajima I, Komada Y, Inoue Y. A meta-analysis on the treatment effectiveness of cognitive behavioral therapy for primary insomnia. Sleep and Biological Rhythms 9(1): 24-34, 2011.
- American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental Disorders (5th ed.). Washington, DC: Author.
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年9月1日
初级完成 (实际的)
2018年11月1日
研究完成 (实际的)
2018年11月1日
研究注册日期
首次提交
2016年8月29日
首先提交符合 QC 标准的
2016年9月1日
首次发布 (估计)
2016年9月2日
研究记录更新
最后更新发布 (实际的)
2019年8月14日
上次提交的符合 QC 标准的更新
2019年8月12日
最后验证
2019年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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VA Office of Research and DevelopmentVA Finger Lakes Healthcare System招聘中
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Indiana UniversityIndiana Clinical and Translational Sciences Institute终止
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University of RochesterNational Institute of Nursing Research (NINR); National Institute of Neurological Disorders... 和其他合作者完全的