ACT for Mental Health in Neurological Disorders

Официальное название

Acceptance and Commitment Therapy- Based Group Therapy for Mental Health in Neurological Disorders

Обзор

The goal of this clinical trial is to examine the efficacy of this manual for mental health in people with mixed neurological disorders, including post-COVID. These conditions are often associated with cognitive impairment, which may hamper the effects of psychoterapy. Executive functioning and especially the ability to abstract thinking may be useful for individuals using Acceptance and Commitment Therapy. Therefore, the main questions research questions are: * Is this intervention effective in improving mental health? * Do executive functions predict the extent of social participation and mental health at the end of therapy? Participants will take part in 8 weekly group therapy sessions of 100 minutes each.

Подробное описание

Mental health issues, especially depression, anxiety, and stress, are common in people with neurological disorders and post-COVID but often neglected and hence, remain untreated. Acceptance and Commitment Therapy (ACT) is a promising approach to assist people in adapting to their conditions by improving "psychological flexibility".

A previous study translated an adapted group psychotherapy manual for stroke survivors into German and demonstrated its feasibility. This pilot study also gave first indications on the manual's efficacy in reducing symptoms of anxiety, depression, and stress. The aim of this study is to investigate the efficacy of this ACT-based group therapy. People with neurological disorders may have impairments in executive functions, which can affect the psychotherapeutic process. Since ACT often uses metaphors and imagery, executive functions, particularly the ability to abstract, could influence the efficacy of the therapy and are therefore being investigated in this study. The program includes 8 weekly sessions with a session length of 100 minutes.

Вмешательства

• Поведенческое ACT-based group therapy
  ACT-based group therapy based on the manual "Living Well with Neurological Conditions" published by Hill et al. (2017; NHS Fundation Trust; available: https://goo.gl/aX6qB5). The manual was translated into German and adapted by shortening sessions, simplifying language and adapting exercises based on clinical experience. The publication of the feasibility study for the adapted manual is currently in preparation. The group therapy includes eight weekly sessions with a duration of 100 minutes each

Первичные конечные точки

• Depression and Anxiety Stress Scales-21 (Lovibond, 1995) [Срок оценки: Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)]
• Acceptance and Action Questionnaire-Acquired Brain Injury (Sylvester, 2011) [Срок оценки: Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)]
• Wechsler Adult Intelligence Scale - Fourth Edition (Similarities subtest; Wechsler, 2008) [Срок оценки: pre- and post-intervention (pre and post are presumably 8 weeks apart)]

Вторичные конечные точки (7)

• Patient Health Questionnaire-9 (Kroenke, 2001) [Срок оценки: Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)]
• Generalized Anxiety Disorder Scale-7 (GAD-7; Spitzer et al., 2007) [Срок оценки: Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)]
• Valuing Questionnaire (Smout, 2014) [Срок оценки: Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)]
• Self-as-context scale (Zettle, 2018) [Срок оценки: Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)]
• World Health Organization Disability Assessment Schedule 2.0 (V.S. Üstün, 2010; Plain German) [Срок оценки: Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)]
• Regensburg Word Fluency Test (Aschenbrenner, 2001) [Срок оценки: pre- and post-intervention (pre and post are presumably 8 weeks apart)]
• Stroop Test in Vienna Test System (Müller & Ziegler, 2001) [Срок оценки: pre- and post-intervention (pre and post are presumably 8 weeks apart)]

Критерии участия

Критерии включения

• Value above a cut-off of the DASS-21 subscales (depression > 10, anxiety > 6, and stress > 10)
• Sufficient cognition and language ability (clinical rating)
• Sufficient therapy motivation (clinical rating)

Критерии исключения

• Behavioral disorders (e.g., high irritability or apathy in clinical rating)
• Other severe mental disorder (dementia, psychosis, personality disorders, intellectual disability)
• Simultaneous psychotherapy or neuropsychological therapy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• Neuropsychologische Hochschulambulanz Bielefeld — Bielefeld

Публикации

• Hill G, Hynd N, Price J, Evans S, Moffitt J, Brechin D. Living Well with Neurological Conditions: An eight-week series of group workshops informed by Acceptance and Commitment Therapy (ACT); 2017. Available from: URL: https://goo.gl/aX6qB5.
• Bowers H, Hill G, Webster A, Bowman AR. Living well with neurological conditions: Clinical outcomes, insights and reflections on three years of Acceptance and Commitment Therapy group intervention. The Neuropsychologist 2021; 1(12):33-42.

Идентификаторы

NCT: NCT06897553 · I-2025-01-13

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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