ACT for Mental Health in Neurological Disorders

NCT06897553 | Recruiting

• 1 other identifier: I-2025-01-13
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Patient Health Questionnaire-9 (Kroenke, 2001)

  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)

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

• Valuing Questionnaire (Smout, 2014)

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

• Self-as-context scale (Zettle, 2018)

  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)

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

Other Outcomes (1)

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

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

Study Arms (1)

Waiting List and ACT group therapy

EXPERIMENTAL

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

Behavioral: ACT-based group therapy

Interventions

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.

Waiting List and ACT group therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bielefeld University: lead

Study Sites (1)

Neuropsychologische Hochschulambulanz Bielefeld

Bielefeld, 33602, Germany

RECRUITING

Related Publications (2)

• 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.

  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.

  BACKGROUND

MeSH Terms

Conditions

Nervous System Diseases; Psychological Well-Being; Depression; Anxiety Disorders; Brain Injuries

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Katja Werheid, Prof

  Bielefeld University

  STUDY CHAIR

Central Study Contacts

Simon Ladwig, PhD

CONTACT

+49 (0) 521 106 67533; simon.ladwig@uni-bielefeld.de

Franziska Supe, M.Sc.

CONTACT

+49 (0) 521 106 67533; franziska-marie.supe@uni-bielefeld.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow (Post-Doc)

Model Details: 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).

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 27, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

DE (1)