Better Sleep in Psychiatric Care - ADHD. (BSIP-ADHD)
21 de octubre de 2019 actualizado por: Susanna Jernelöv, Karolinska Institutet
Better Sleep in Psychiatric Care - ADHD. A Randomized Naturalistic Study of a Psychological Group Treatment for Sleep Problems in Psychiatric Patients With Attention Deficit Hyperactivity Disorder.
Cognitive Behavioral Therapy (CBT) is treatment of choice for insomnia (CBT-i).
Many patients in psychiatric care have sleep problems including insomnia, but are rarely given the choice to participate in CBT to improve their sleep.
Patients with ADHD is a patient group with high levels of sleep difficulties.
Sleep problems in this patient group can be both more general such as insomnia, but can also be related to the ADHD itself and to the use of ADHD medication.
In a previous pilot study, the investigators developed a version of CBT-i that would target sleep problems in this population.
The basis was CBT-i, but with more emphasis on sleep promoting behaviors specific to ADHD (e.g.
appropriate timing of ADHD-medication), techniques that would also alleviate sleep phase problems, (e.g. the systematic use of light and darkness), and techniques to target more general sleep disturbing habits (e.g.
not winding down before bed time), that are also common in patients with ADHD.
This treatment was well tolerated and gave moderate effects on insomnia severity in the pilot study.
In a naturalistic randomized controlled trial, the investigators now evaluate the effects of this psychological treatment on sleep and symptoms of ADHD in patients at the ADHD-clinics, Northern Stockholm Psychiatry, Sweden.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
58
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
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Stockholm, Suecia, 113 21
- Department of ADHD, Northern Stockholm Psychiatry
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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:
- Being a patient at the ADHD-clinics Northern Stockholm Psychiatry
- Experiencing sleep problems (subjective report)
Exclusion Criteria:
- None
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: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Behavioral: Adjusted CBT-i for ADHD
Cognitive Behavioral group intervention for sleep problems in ADHD, based on Cognitive Behavioral Therapy for insomnia and behavioral treatment for Sleep Phase Disorders.
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This is a version of CBT for insomnia (CBT-i) developed during the pilot phase of this Project.
Traditional CBT-i is adjusted for use in the adult ADHD population.
This behavioral intervention adresses not only traditional aspects of insomnia, but also sleep phase problems and other aspects of sleep specifically relevant to the ADHD-population.
Treatment is given as 10 weekly group sessions with telephone calls from the therapist between sessions to increase adherence and adress individual patient needs.
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Otro: Treatment as Usual
Treatment as Usual.
(After about ten weeks, participants in this condition are offered the experimental group treatment.)
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Usual care at the ADHD-clinic.
This mostly entails managing pharmacological treatment for ADHD, comorbid psychiatric problems and/or sleep problems.
The clinic also provides different group treatments, for instance mindfulness groups and groups for developing behavioral strategies for managing ADHD symptoms, and individual therapy.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Insomnia Severity Index
Periodo de tiempo: Changes from base-line to 10 weeks and 3 months
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7-item, self-rated questionnaire measuring change in insomnia severity.
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Changes from base-line to 10 weeks and 3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Actigraphy
Periodo de tiempo: Continuously from treatment start (week 1) to the last week of treatment (week 10)
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An actigraph is placed on the participant's arm for one week.
It measures participants' activity in the form of movements.
It can be used for acquiring data on sleep and daytime activity, including calculated sleep latency, total sleep time, sleep efficiency, wake after sleep onset, variability in sleep timing and daytime activity.
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Continuously from treatment start (week 1) to the last week of treatment (week 10)
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Sleep diary
Periodo de tiempo: Changes from base-line to 10 weeks and 3 months
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Daily self-ratings on a number of sleep parameters, resulting in several measures including sleep latency, wake after sleep onset, total sleep time, sleep efficiency, subjective sleep quality and variability in sleep timing
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Changes from base-line to 10 weeks and 3 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Brunnsviken brief quality of life scale
Periodo de tiempo: Changes from base-line to 10 weeks and 3 months
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12-items self-rating questionnaire measuring quality of life.
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Changes from base-line to 10 weeks and 3 months
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Adult ADHD Self-Report Scale
Periodo de tiempo: Changes from base-line to 10 weeks and 3 months
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18-items self-report questionnaire measuring ADHD-symptoms.
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Changes from base-line to 10 weeks and 3 months
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Dysfunctional Beliefs and Attitudes about Sleep
Periodo de tiempo: Changes from base-line to 10 weeks and 3 months
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10-items self-rating questionnaire measuring sleep related cognitions.
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Changes from base-line to 10 weeks and 3 months
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Sleep Problems Acceptance Questionnaire
Periodo de tiempo: Changes from base-line to 10 weeks and 3 months
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8-items self-rating questionnaire measuring acceptance of sleep problems.
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Changes from base-line to 10 weeks and 3 months
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Sleep habits and behaviors
Periodo de tiempo: Changes from base-line to 10 weeks and 3 months
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Self-rating questionnaire regarding the use of sleep promoting behaviors.
The questionnaire was constructed for the current project and consists of two parts.
The first part includes 16 statements such as "Last week I got out of bed within 15 minutes of waking up" to be answered by number of days the last week this was true (i.e. from 0 to 7).
The other part is to be answered on a 6-point Likert scale from "Not at all true" to "Entirely true", with 7 statements like "I get out of bed the same time every morning".
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Changes from base-line to 10 weeks and 3 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Susanna Jernelöv, PhD, LP, Karolinska Institutet
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
- Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
- Adler LA, Spencer T, Faraone SV, Kessler RC, Howes MJ, Biederman J, Secnik K. Validity of pilot Adult ADHD Self- Report Scale (ASRS) to Rate Adult ADHD symptoms. Ann Clin Psychiatry. 2006 Jul-Sep;18(3):145-8. doi: 10.1080/10401230600801077.
- Lindner P, Frykheden O, Forsstrom D, Andersson E, Ljotsson B, Hedman E, Andersson G, Carlbring P. The Brunnsviken Brief Quality of Life Scale (BBQ): Development and Psychometric Evaluation. Cogn Behav Ther. 2016 Apr;45(3):182-95. doi: 10.1080/16506073.2016.1143526. Epub 2016 Feb 17.
- Espie CA, Inglis SJ, Harvey L, Tessier S. Insomniacs' attributions. psychometric properties of the Dysfunctional Beliefs and Attitudes about Sleep Scale and the Sleep Disturbance Questionnaire. J Psychosom Res. 2000 Feb;48(2):141-8. doi: 10.1016/s0022-3999(99)00090-2.
- Bothelius K, Jernelov S, Fredrikson M, McCracken LM, Kaldo V. Measuring Acceptance of Sleep Difficulties: The Development of the Sleep Problem Acceptance Questionnaire. Sleep. 2015 Nov 1;38(11):1815-22. doi: 10.5665/sleep.5170.
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 diciembre de 2016
Finalización primaria (Actual)
21 de noviembre de 2018
Finalización del estudio (Actual)
21 de noviembre de 2018
Fechas de registro del estudio
Enviado por primera vez
6 de enero de 2017
Primero enviado que cumplió con los criterios de control de calidad
9 de enero de 2017
Publicado por primera vez (Estimar)
10 de enero de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de octubre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
21 de octubre de 2019
Última verificación
1 de octubre de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2016/1988-31
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
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. .
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