ACT for Mental Health in Neurological Disorders

Bielefeld University

Status: Enrolling

Conditions: Executive Function (Cognition); Post-COVID; Brain Injury; Depression/Anxiety; Neurological Disorders; Stress; Mental Health

Treatments: Behavioral: ACT-based group therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06897553

I-2025-01-13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Waiting List and ACT group therapy

Experimental group

Description:

Eight weeks of waiting list are followed by eight weeks of ACT group therapy, see study design.

Treatment:

Behavioral: ACT-based group therapy