이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

A Pragmatic Pilot Study of Cognitive Behavioural Therapy for Insomnia Among People Living With HIV

2019년 8월 12일 업데이트: 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.

연구 개요

상태

완전한

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

10

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Ontario
      • Toronto, Ontario, 캐나다, M5B 2K3
        • Department of Psychology, Ryerson University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: CBT-I
This is a single arm study in which all participants receive the intervention (cognitive behavioural therapy for insomnia)
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Insomnia symptom severity
기간: Two weeks post-treatment
Insomnia symptom severity is measured using the Insomnia Severity Index (ISI)
Two weeks post-treatment

2차 결과 측정

결과 측정
측정값 설명
기간
CD4+ (cluster of differentiation 4) cell count
기간: Within two months post-treatment
Obtained via self-report based on blood test results in past 3 months
Within two months post-treatment
HIV viral load
기간: Within two months post-treatment
Obtained via self-report based on blood test results in past 3 months
Within two months post-treatment
Combined antiretroviral therapy (cART) medication adherence
기간: Two weeks post-treatment
Measured using the Self-Rating Scale Item (SRSI) and Simplified Medication Adherence Questionnaire (SMAQ)
Two weeks post-treatment
Sleep efficiency
기간: Two weeks post-treatment
Sleep efficiency is the amount of time spent sleeping vs. awake in bed
Two weeks post-treatment
Total wake time
기간: Two weeks post-treatment
Total wake time is the total time spent awake between getting into bed at night
Two weeks post-treatment

기타 결과 측정

결과 측정
측정값 설명
기간
Health-related quality of life
기간: Two weeks post-treatment
Measured using the Medical Outcomes Study Short-Form Health Survey (SF-36)
Two weeks post-treatment
Depression symptom severity
기간: Two weeks post-treatment
Measured using the Centre for Epidemiological Studies in Depression Scale-Revised (CESD-R) and Depression Anxiety Stress Scales (DASS-21)
Two weeks post-treatment
Treatment acceptability
기간: Immediately post-treatment (final therapy session)
Measured using the Therapy Evaluation Questionnaire (TEQ)
Immediately post-treatment (final therapy session)
Intervention safety
기간: Two weeks post-treatment
Measured via qualitative exit interview, and includes any unwanted or adverse events associated with the intervention
Two weeks post-treatment
Dysfunctional beliefs about sleep
기간: Two weeks post-treatment
Measured using the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16)
Two weeks post-treatment
Sleep effort
기간: Two weeks post-treatment
Measured using the Glasgow Sleep Effort Scale (GSES)
Two weeks post-treatment
Self-efficacy for sleep
기간: Two weeks post-treatment
Measured using the Self-Efficacy for Sleep Scale (SE-S)
Two weeks post-treatment
Pre-sleep arousal
기간: Two weeks post-treatment
Measured using the Pre-Sleep Arousal Scale (PSAS-13)
Two weeks post-treatment
Fatigue
기간: Two weeks post treatment
Measured using the Fatigue Severity Scale (FSS)
Two weeks post treatment
Anxiety Symptom Severity
기간: Two weeks post treatment
Measured using the Depression Anxiety Stress Scales (DASS-21)
Two weeks post treatment
HIV-Related Fatigue
기간: Two weeks post treatment
Measured using the HIV-Related Fatigue Scale (HRFS)
Two weeks post treatment

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Tyler Tulloch, MA, Ryerson University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2016년 9월 1일

기본 완료 (실제)

2018년 11월 1일

연구 완료 (실제)

2018년 11월 1일

연구 등록 날짜

최초 제출

2016년 8월 29일

QC 기준을 충족하는 최초 제출

2016년 9월 1일

처음 게시됨 (추정)

2016년 9월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 8월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 8월 12일

마지막으로 확인됨

2019년 8월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • PSS (기타 보조금/기금 번호: Panaceo International Active Mineral Production GmbH)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

CBT-I에 대한 임상 시험

3
구독하다