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

12 de agosto de 2019 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

10

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Insomnia symptom severity
Periodo de tiempo: Two weeks post-treatment
Insomnia symptom severity is measured using the Insomnia Severity Index (ISI)
Two weeks post-treatment

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
CD4+ (cluster of differentiation 4) cell count
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Two weeks post-treatment
Measured using the Self-Rating Scale Item (SRSI) and Simplified Medication Adherence Questionnaire (SMAQ)
Two weeks post-treatment
Sleep efficiency
Periodo de tiempo: Two weeks post-treatment
Sleep efficiency is the amount of time spent sleeping vs. awake in bed
Two weeks post-treatment
Total wake time
Periodo de tiempo: Two weeks post-treatment
Total wake time is the total time spent awake between getting into bed at night
Two weeks post-treatment

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Health-related quality of life
Periodo de tiempo: Two weeks post-treatment
Measured using the Medical Outcomes Study Short-Form Health Survey (SF-36)
Two weeks post-treatment
Depression symptom severity
Periodo de tiempo: 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
Periodo de tiempo: Immediately post-treatment (final therapy session)
Measured using the Therapy Evaluation Questionnaire (TEQ)
Immediately post-treatment (final therapy session)
Intervention safety
Periodo de tiempo: 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
Periodo de tiempo: Two weeks post-treatment
Measured using the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16)
Two weeks post-treatment
Sleep effort
Periodo de tiempo: Two weeks post-treatment
Measured using the Glasgow Sleep Effort Scale (GSES)
Two weeks post-treatment
Self-efficacy for sleep
Periodo de tiempo: Two weeks post-treatment
Measured using the Self-Efficacy for Sleep Scale (SE-S)
Two weeks post-treatment
Pre-sleep arousal
Periodo de tiempo: Two weeks post-treatment
Measured using the Pre-Sleep Arousal Scale (PSAS-13)
Two weeks post-treatment
Fatigue
Periodo de tiempo: Two weeks post treatment
Measured using the Fatigue Severity Scale (FSS)
Two weeks post treatment
Anxiety Symptom Severity
Periodo de tiempo: Two weeks post treatment
Measured using the Depression Anxiety Stress Scales (DASS-21)
Two weeks post treatment
HIV-Related Fatigue
Periodo de tiempo: Two weeks post treatment
Measured using the HIV-Related Fatigue Scale (HRFS)
Two weeks post treatment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Tyler Tulloch, MA, Ryerson University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 2016

Finalización primaria (Actual)

1 de noviembre de 2018

Finalización del estudio (Actual)

1 de noviembre de 2018

Fechas de registro del estudio

Enviado por primera vez

29 de agosto de 2016

Primero enviado que cumplió con los criterios de control de calidad

1 de septiembre de 2016

Publicado por primera vez (Estimar)

2 de septiembre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de agosto de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

12 de agosto de 2019

Última verificación

1 de agosto de 2019

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • PSS (Otro número de subvención/financiamiento: Panaceo International Active Mineral Production GmbH)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre CBT-I

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