Clinical trial NCT06897553: ACT for Mental Health in Neurological Disorders
Official title: Acceptance and Commitment Therapy- Based Group Therapy for Mental Health in Neurological Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurological Disorders
Mental Health
Executive Function (Cognition)
Depression/Anxiety
Stress
Brain Injury
Post-COVID
Keywords: Acceptance and Commitment Therapy (ACT)
group therapy
neurological disorders
brain injury
anxiety
stress
depression
executive functioning
abstraction ability
Post-COVID
Lead sponsor: Bielefeld University
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study design is adaptive based on the recruitment rate. The study starts with only an intervention condition, in a pre/post design. If recruitment allows for, participants will first enter a waiting list condition over eight weeks and then commence the group therapy (intervention condition). Three assessments take place at start of waiting, start of group therapy (pre) and end of group therapy (post).
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Depression and Anxiety Stress Scales-21 (Lovibond, 1995)
timeFrame: Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)
measure: Acceptance and Action Questionnaire-Acquired Brain Injury (Sylvester, 2011)
timeFrame: Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)
measure: Wechsler Adult Intelligence Scale - Fourth Edition (Similarities subtest; Wechsler, 2008)
timeFrame: pre- and post-intervention (pre and post are presumably 8 weeks apart)
Secondary outcomes:
measure: Patient Health Questionnaire-9 (Kroenke, 2001)
timeFrame: Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)
measure: Generalized Anxiety Disorder Scale-7 (GAD-7; Spitzer et al., 2007)
timeFrame: Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)
measure: Valuing Questionnaire (Smout, 2014)
timeFrame: Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)
measure: Self-as-context scale (Zettle, 2018)
timeFrame: Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)
measure: World Health Organization Disability Assessment Schedule 2.0 (V.S. Üstün, 2010; Plain German)
timeFrame: Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)
measure: Regensburg Word Fluency Test (Aschenbrenner, 2001)
timeFrame: pre- and post-intervention (pre and post are presumably 8 weeks apart)
measure: Stroop Test in Vienna Test System (Müller & Ziegler, 2001)
timeFrame: pre- and post-intervention (pre and post are presumably 8 weeks apart)
Other outcomes:
measure: Group therapy session questionnaire (Zoubek, 2013; Plain German)
timeFrame: GTS-P Session and GTS-T during the intervention (weekly, after each session), GTS-P Total post-intervention
Locations:
city: Bielefeld
country: Germany
facility: Neuropsychologische Hochschulambulanz Bielefeld
Study officials:
affiliation: Bielefeld University
name: Katja Werheid, Prof
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.