ACT for Mental Health in Neurological Disorders

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stress; Brain Injury; Neurological Disorders; Mental Health; Post-COVID; Depression/Anxiety; Executive Function (Cognition)
• Intervention / Treatment: Behavioral: ACT-based group therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simon Ladwig, PhD; Phone Number: +49 (0) 521 106 67533; Email: simon.ladwig@uni-bielefeld.de
• Study Contact Backup: Name: Franziska Supe, M.Sc.; Phone Number: +49 (0) 521 106 67533; Email: franziska-marie.supe@uni-bielefeld.de

Study Locations

• Germany
  • Bielefeld, Germany, 33602
    • Recruiting
    • Neuropsychologische Hochschulambulanz Bielefeld
    • Contact: Simon Ladwig, PhD; Phone Number: +49 (0) 521 106 67533; Email: simon.ladwig@uni-bielefeld.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Waiting List and ACT group therapy; Eight weeks of waiting list are followed by eight weeks of ACT group therapy, see study design.

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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression and Anxiety Stress Scales-21 (Lovibond, 1995)	Measure of psychological burden to investigate efficacy. Scores range from 0 to 63 with higher values indicating higher burden.	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)	Measure of psychological flexibility to investigate efficacy. Scores range from 0 to 36 with higher values indicating higher inflexibility.	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)	Measure of individual's ability to recognize and articulate the commonalities between different objects, reflecting their abstraction ability. This will be used to examine the influence of the ability of abstract thinking. Scores range from 0 to 36 with higher values indicating higher ability of abstraction.	pre- and post-intervention (pre and post are presumably 8 weeks apart)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9 (Kroenke, 2001)	Measure of depressive symptoms to investigate efficacy. Scores range from 0 to 27 with higher values indicating more severe depressive symptoms.	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)	Measure of anxiety symptoms to investigate efficacy. Scores range from 0 to 21 with higher scores indicating higher anxiety.	Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)
Valuing Questionnaire (Smout, 2014)	Measure of valued living to investigate efficacy. Scores range from 0 to 60 with higher values indicating higher value-congruent living.	Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)
Self-as-context scale (Zettle, 2018)	Measure of self as context to investigate efficacy. Scores range from 10 to 70 with higher values indicating a perspective closer to self-as-context.	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)	Measure of functional impairments and disabilities.	Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)
Regensburg Word Fluency Test (Aschenbrenner, 2001)	Measure of verbal fluency.	pre- and post-intervention (pre and post are presumably 8 weeks apart)
Stroop Test in Vienna Test System (Müller & Ziegler, 2001)	Measure of cognitive flexibility and inhibition of irrelevant stimuli.	pre- and post-intervention (pre and post are presumably 8 weeks apart)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Group therapy session questionnaire (Zoubek, 2013; Plain German)	Measure of treatment acceptance and satisfaction for patients regarding each session (GTS-P Session), for patients regarding the entire therapy (GTS-P Total), and for therapists regarding the each session (GTS-T). GTS-P Session scores from 0 to 24 with higher values indicating higher acceptance. GTS-P Total scores from 0 to 8 with higher values indicating higher acceptance. GTS-T scores from 0 to 48 with higher values indicating higher acceptance.	GTS-P Session and GTS-T during the intervention (weekly, after each session), GTS-P Total post-intervention

Collaborators and Investigators

• Sponsor: Bielefeld University
• Investigators: Study Chair: Katja Werheid, Prof, Bielefeld University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: depression; anxiety; stress; brain injury; Acceptance and Commitment Therapy (ACT); executive functioning; Post-COVID; group therapy; neurological disorders; abstraction ability
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Wounds and Injuries; Behavioral Symptoms; Craniocerebral Trauma; Trauma, Nervous System; Depression; Brain Injuries; Nervous System Diseases
• Other Study ID Numbers: I-2025-01-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be shared on public repository like Mendeley Data, while ensuring that no individual may be identified by the data.
• IPD Sharing Time Frame: IPD will be available latest six months after completion of data collection, presumably January, 1st, 2027. Data will be deleted after ten years.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No