ACT for Mental Health in Neurological Disorders

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Behavioral 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

Primary outcome measures

• Depression and Anxiety Stress Scales-21 (Lovibond, 1995) [Time frame: 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) [Time frame: 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) [Time frame: pre- and post-intervention (pre and post are presumably 8 weeks apart)]

Secondary outcome measures (7)

• Patient Health Questionnaire-9 (Kroenke, 2001) [Time frame: 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) [Time frame: Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)]
• Valuing Questionnaire (Smout, 2014) [Time frame: Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)]
• Self-as-context scale (Zettle, 2018) [Time frame: 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) [Time frame: Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)]
• Regensburg Word Fluency Test (Aschenbrenner, 2001) [Time frame: pre- and post-intervention (pre and post are presumably 8 weeks apart)]
• Stroop Test in Vienna Test System (Müller & Ziegler, 2001) [Time frame: pre- and post-intervention (pre and post are presumably 8 weeks apart)]

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Germany · 1 center

• Neuropsychologische Hochschulambulanz Bielefeld — Bielefeld

Publications

• 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.

Identifiers

NCT: NCT06897553 · I-2025-01-13

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗