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Идёт набор NCT05986604

NIA_Improving Function and Well-being by Improving Patient Memory: Transdiagnostic Sleep and Circadian Treatment

Без фазы С лечением Sleep Disorder Circadian Dysregulation Memory Impairment

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Memory Support Intervention, Transdiagnostic Intervention for Sleep and Circadian Dysfunction.
Кому может быть актуально
Состояния в реестре: Sleep Disorder, Circadian Dysregulation, Memory Impairment. Базовые параметры: от 50 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

NIA_Improving Sleep and Circadian Functioning, Daytime Functioning, and Well-being for Midlife and Older Adults by Improving Patient Memory for a Transdiagnostic Sleep and Circadian Treatment

Обзор

Mental illness is often chronic, severe, and difficult to treat. Though there has been significant progress towards establishing effective and efficient interventions for psychological health problems, many individuals do not gain lasting benefits from these treatments. The Memory Support Intervention (MSI) was developed utilizing existing findings from the cognitive science literature to improve treatment outcomes. In this study, the investigators aim to conduct an open trial that includes individuals 50 years and older to assess if a novel version of the Memory Support Intervention improves sleep and circadian functioning, reduces functional impairment, and improves patient memory for treatment.

Подробное описание

Life expectancy has increased drastically in the United States. Longer life is too often associated with illness, discomfort, disability, and dependency. Progress toward promoting health and well-being as we age must include the identification of novel treatment targets that are safe, powerful, inexpensive, and deployable. The proposed research will test one such target-patient memory for the contents of treatment.

Over 5 years, we will recruit adults who are 50 years and older and who are experiencing sleep and circadian problems (n = 178, including 20% for attrition). Participants will be randomly allocated to TranS-C plus the MSI ("TranS-C+MSI") or TranS-C alone via eight 50-minute, weekly, individual sessions. Assessments will be conducted at baseline, post-treatment, and at 6- and 12-month follow-up (6FU and 12FU).

Specific Aim 1: To evaluate if adding the MSI to TranS-C (a) improves sleep and circadian functioning, (b) improves daytime functioning, (c) improves well-being and (d) improves patient memory by comparing the effects of TranS-C+MSI vs. TranS-C alone. Hypothesis 1. Compared to TranS-C alone, people who receive TranS-C+MSI will improve more on all outcomes at post-treatment, 6FU and 12FU.

Specific Aim 2: To evaluate if patient memory for treatment mediates the relation between treatment condition and sleep and circadian functioning. Hypothesis 2. TranS-C+MSI will be associated with better memory for treatment relative to TranS-C alone, and in turn, better memory for treatment will be associated with better sleep and circadian functioning immediately following treatment and at 6FU and 12FU.

Specific Aim 3: To evaluate if subgroups hypothesized to derive added benefit from memory support moderate (a) patient memory for treatment and (b) treatment outcome. Hypothesis 3. Treatment effects for TranS-C+MSI will be larger at post-treatment for those who are older, have fewer years of education, poorer baseline cognitive functioning and more severe baseline sleep disruption and sleep-related impairment.

Exploratory analyses will compare the treatments on (a) patient adherence as well as patient-rated treatment credibility and utilization of treatment elements and (b) provider-rated acceptability, appropriateness, and feasibility.

Вмешательства

  • Поведенческое Memory Support Intervention
    The Memory Support Intervention is designed to improve patient memory for treatment and involves a series of specific procedures that support the encoding and retrieval stages of episodic memory. The memory support strategies are proactively, strategically and intensively integrated into treatment-as-usual to support encoding. Memory support is delivered alongside each 'treatment point', defined as a main idea, principle, or experience that the treatment provider wants the patient to remember or
  • Поведенческое Transdiagnostic Intervention for Sleep and Circadian Dysfunction
    TranS-C aims to provide one protocol to treat a range of sleep and circadian problems because sleep and circadian problems are often not so neatly categorized and because the existing research provides few guidelines to treat more complex patients.

Первичные конечные точки

  • Patient-Reported Outcomes Measurement Information System - Sleep Disturbance [Срок оценки: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
  • Sheehan Disability Scale [Срок оценки: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
  • Satisfaction with Life Scale [Срок оценки: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
Вторичные конечные точки (12)
  • Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment [Срок оценки: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
  • Positive and Negative Affect Scale [Срок оценки: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
  • WHODAS 2.0 [Срок оценки: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
  • Cognitive Failures Questionnaire [Срок оценки: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
  • Epworth Sleepiness Scale [Срок оценки: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
  • Memory for Treatment: Cumulative recall [Срок оценки: Week 4 of treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 8-10 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up]]
  • Thoughts and Applications Task [Срок оценки: Week 4 of treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 8-10 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up]]
  • Adapted Utilization Scale [Срок оценки: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
  • Composite Sleep Health Score [Срок оценки: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
  • Mean sleep efficiency (Daily Sleep Diary) [Срок оценки: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
  • Mean total wake time (Daily Sleep Diary) [Срок оценки: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
  • Mean for total sleep time (Daily Sleep Diary) [Срок оценки: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]

Критерии участия

Критерии включения

  • Aged 50 years and older;
  • English language fluency;
  • Experiencing a mobility impairment;
  • Low income;
  • Exhibit a sleep or circadian disturbance as determined by endorsing 4 "quite a bit" or 5 "very much" (or the equivalent for reverse scored items) on one or more PROMIS-SD questions.
  • 25-30 on the Montreal Cognitive Assessment, as a negative screen for cognitive impairment.
  • Able/willing to give informed consent.

Критерии исключения

  • Severe untreated sleep disordered breathing (AHI>30) or moderate untreated sleep disordered breathing with severe daytime sleepiness (AHI of 15-30 and Epworth Sleepiness Scale >10);
  • Medical conditions that prevent a participant from comprehending and following the basic tenants of treatment (e.g., dementia) or that interfere with sleep in a manner that can't be addressed by a cognitive behavioral treatment (e.g., the Structured Clinical Interview for Sleep Disorders will be used to screen for narcolepsy, REM sleep behavior disorder) or that may preclude full participation (e.g., receipt of end of life care);
  • Homelessness;
  • Night shift work >2 nights per week in the past 3 months;
  • Substance abuse/dependence only if it makes participation in the study unfeasible;
  • Suicide risk sufficient to preclude treatment on an outpatient basis.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of California, Berkeley — Berkeley

Публикации

  • Milner AE, Hache RE, Oliver S, Sarfan LD, Spencer JM, Cogan A, Jiang Y, Agnew ER, Zieve GG, Martin JL, Zeidler MR, Dong L, Carpenter JK, Varghese J, Bol K, Bajwa Z, Tighe CA, Harvey AG. Integrating the Memory Support Intervention into the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C): can improving memory for treatment in midlife and older adults improve patient outcom PMID 39363383

Идентификаторы

NCT: NCT05986604 · TranS-C+MSI vs. TranS-C Alone

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗