Accelerated Resolution Therapy for Early Maladaptive Grief

Официальное название

Accelerated Resolution Therapy for Early Maladaptive Grief: A Clinical Trial

Обзор

The purpose study is to test the effects of accelerated resolution therapy (ART) on pre-loss grief and prolonged grief disorder among older adult family caregivers (FCGs). Additionally, to better understand predictors of response to ART, and cognitive processes that occur among grieving individuals following ART.

Подробное описание

Accelerated Resolution Therapy (ART) is an evidence-based treatment for post-traumatic distress in civilians and veterans that may be useful in alleviating maladaptive grief prior to bereavement and could prevent prolonged grief disorder following bereavement. Researchers are proposing to test the efficacy of ART, a low-risk, brief therapy with a strong theoretical rationale for treatment success in maladaptive grief and supported by the promising results of a recently completed preliminary trial. Additional aims of the study are to examine changes in cognitive appraisal and integration of loss following ART using a mixed methods approach and to evaluate personal, social, and psychological factors predictors of response.

During the proposed double blinded, randomized, controlled two arm clinical trial, older adult family caregivers will receive either ART or an educational program that is matched for time and attention. Each participant will receive four sessions of either the ART intervention or the control intervention. Data collection will occur at screening/enrollment (T1), at the end of the 4-session intervention period (T2) and at 6-months (T3) and 13-months post bereavement (T4). A subgroup of 20 participants randomly assigned to ART will participate in semi-structured interviews to enhance understanding of cognitive appraisal and integration of loss.

This trial will provide critical information on the efficacy of the ART intervention as a potential first-line treatment option for pre-loss grief and preventative option for prolonged grief disorder, and contribute new information about characteristics of individuals most likely to benefit from ART.

Вмешательства

• Поведенческое Accelerated Resolution Therapy
  A brief psychotherapeutic intervention delivered by trained therapists in a maximum of 4 sessions. Sessions will focus on providing relief from the distress related to an anticipated loss and to shift focus from distress and loss back to the relationship.
• Другое Information and Support
  4 sessions of a standardized social work intervention. Standard of care including education and active listening.

Первичные конечные точки

• Changes in pre-loss grief [Срок оценки: Baseline, 4 weeks]
• Changes in prolonged grief disorder [Срок оценки: 6 and 13 months post-bereavement]
• Changes in clinical measure of prolonged grief disorder [Срок оценки: 6 and 13 months post-bereavement]

Критерии участия

Критерии включения

• Primary caregiver of immediate family member who has a life expectancy of less than 12 months
• Score of 30 or higher on the PG-12-R, indicating clinically significant pre-loss grief
• Denial of suicidal ideation or intent, with no evidence of psychotic behavior.

Критерии исключения

• Since becoming a family caregiver (FCG), they have engaged in another trauma based psychotherapeutic regimen (EMDR, prolonged exposure therapy, trauma focused cognitive behavioral therapy) that could influence response to accelerated resolution therapy (ART).
• Self-reported or clinically assessed major psychiatric disorder (e.g., bipolar disorder, schizophrenia).
• Score of > 2 on the adapted CAGE questionnaire indicating alcohol /drug dependence.
• Cognitive impairment (SPMSQ > 4 errors).

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

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 4 центра

• Mayo Clinic Arizona — Phoenix
• Suncoast Hospice — Clearwater
• Mayo Clinic Florida — Jacksonville
• Mayo Clinic — Rochester

Идентификаторы

NCT: NCT05624879 · 22-005315 · R01AG077656

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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