ACT for Mental Health in Neurological Disorders

NCT ID: NCT06897553

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Waiting List and ACT group therapy

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

Group Type: EXPERIMENTAL

ACT-based group therapy

Intervention Type: BEHAVIORAL

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. Three to six individuals participate in a group. The therapy is delivered by at least one licensed psychotherapists. A co-therapist might be included based on individual needs of the group members.

Interventions

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. Three to six individuals participate in a group. The therapy is delivered by at least one licensed psychotherapists. A co-therapist might be included based on individual needs of the group members.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bielefeld University

OTHER

Sponsor Role: lead

Responsible Party

Simon Ladwig

Research Fellow (Post-Doc)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katja Werheid, Prof

Role: STUDY_CHAIR

Bielefeld University

Locations

Neuropsychologische Hochschulambulanz Bielefeld

Bielefeld, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Simon Ladwig, PhD

Role: CONTACT

simon.ladwig@uni-bielefeld.de

+49 (0) 521 106 67533

Franziska Supe, M.Sc.

Role: CONTACT

franziska-marie.supe@uni-bielefeld.de

+49 (0) 521 106 67533

Facility Contacts

Simon Ladwig, PhD

Role: primary

simon.ladwig@uni-bielefeld.de

+49 (0) 521 106 67533

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

Other Identifiers

I-2025-01-13

Identifier Type: -

Identifier Source: org_study_id