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NCT Number: NCT06897553

ACT 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.

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Key information

Conditions

Neurological Disorders Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Brain Injuries Brain Injury Central Nervous System Diseases Craniocerebral Trauma Depression Depression/Anxiety Executive Function (Cognition) Mental Disorders Mental Health Nervous System Diseases Personal Satisfaction Post-COVID Psychological Well-Being Stress Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACT-based group therapy

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.

Primary outcomes

  1. 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)

    Measure of psychological burden to investigate efficacy. Scores range from 0 to 63 with higher values indicating higher burden.

  2. 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)

    Measure of psychological flexibility to investigate efficacy. Scores range from 0 to 36 with higher values indicating higher inflexibility.

  3. Wechsler Adult Intelligence Scale - Fourth Edition (Similarities subtest; Wechsler, 2008)

    Time frame: pre- and post-intervention (pre and post are presumably 8 weeks apart)

    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.

Secondary outcomes

  1. 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)

    Measure of depressive symptoms to investigate efficacy. Scores range from 0 to 27 with higher values indicating more severe depressive symptoms.

  2. 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)

    Measure of anxiety symptoms to investigate efficacy. Scores range from 0 to 21 with higher scores indicating higher anxiety.

  3. Valuing Questionnaire (Smout, 2014)

    Time frame: Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)

    Measure of valued living to investigate efficacy. Scores range from 0 to 60 with higher values indicating higher value-congruent living.

  4. 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)

    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.

  5. 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)

    Measure of functional impairments and disabilities.

  6. Regensburg Word Fluency Test (Aschenbrenner, 2001)

    Time frame: pre- and post-intervention (pre and post are presumably 8 weeks apart)

    Measure of verbal fluency.

  7. Stroop Test in Vienna Test System (Müller & Ziegler, 2001)

    Time frame: pre- and post-intervention (pre and post are presumably 8 weeks apart)

    Measure of cognitive flexibility and inhibition of irrelevant stimuli.

Other outcomes

  1. Group therapy session questionnaire (Zoubek, 2013; Plain German)

    Time frame: GTS-P Session and GTS-T during the intervention (weekly, after each session), GTS-P Total post-intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Franziska Supe, M.Sc.

CONTACT

[email protected]

+49 (0) 521 106 67533

Simon Ladwig, PhD

CONTACT

[email protected]

+49 (0) 521 106 67533

Sponsors and collaborators

Lead sponsor

Bielefeld University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2025
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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