Neurological DisordersNCT06897553
ACT for Mental Health in Neurological Disorders
A study testing ACT-based group therapy in people with Neurological Disorders and Mental Health, run by Bielefeld University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurological Disorders, Mental Health, Executive Function (Cognition)
- What is being tested?
- ACT-based group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Neuropsychologische Hochschulambulanz Bielefeld
Bielefeld, 33602
Simon Ladwig, PhD, +49 (0) 521 106 67533, simon.ladwig@uni-bielefeld.de
About this study
Official title: 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.
Read the 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
- Being tested
- ACT-based group therapy
- Keywords
- Acceptance and Commitment Therapy (ACT), group therapy, neurological disorders, brain injury, anxiety, stress, depression, executive functioning, abstraction ability, Post-COVID
- Medical subject headings
- Nervous System Diseases, Psychological Well-Being, Depression, Anxiety Disorders, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-based group therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Waiting List and ACT group therapy | Experimental | Eight weeks of waiting list are followed by eight weeks of ACT group therapy, see study design. Receives: Behavioral: ACT-based group therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: pre- and post-intervention (pre and post are presumably 8 weeks apart)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: pre- and post-intervention (pre and post are presumably 8 weeks apart)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 Dec 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neurological DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bielefeld University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Ladwig, Bielefeld University
- Investigators
- Katja Werheid, Prof, Study chair, Bielefeld University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897553
- Sponsor's protocol ID
- I-2025-01-13
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared on public repository like Mendeley Data, while ensuring that no individual may be identified by the data.
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 at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy- Based Group Therapy for Mental Health in Neurological Disorders
- ClinicalTrials.gov ID
- NCT06897553
- Acronym / sponsor ID
- I-2025-01-13
- Conditions
- Neurological Disorders, Mental Health, Executive Function (Cognition), Depression/Anxiety, Stress, Brain Injury
- Keywords
- Acceptance and Commitment Therapy (ACT), group therapy, neurological disorders, brain injury, anxiety, stress, depression, executive functioning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Bielefeld UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Waiting List and ACT group therapy | Experimental | Behavioral: ACT-based group therapyEight weeks of waiting list are followed by eight weeks of ACT group therapy, see study design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT-based group therapyACT-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. | Behavioural | Waiting List and ACT group therapy |
Primary outcome
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.
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.
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.
7 secondary outcomes
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)
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)
Valuing Questionnaire (Smout, 2014)
Time frame: Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)
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)
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)
Regensburg Word Fluency Test (Aschenbrenner, 2001)
Time frame: pre- and post-intervention (pre and post are presumably 8 weeks apart)
Stroop Test in Vienna Test System (Müller & Ziegler, 2001)
Time frame: pre- and post-intervention (pre and post are presumably 8 weeks apart)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- BackgroundHill 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.
- BackgroundBowers 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.
- Individual participant dataSharing planned: Yes. IPD will be shared on public repository like Mendeley Data, while ensuring that no individual may be identified by the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katja Werheid, Prof study chair
Bielefeld University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT-based group therapy in people with Neurological Disorders and Mental Health, run by Bielefeld University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Ladwig, PhD (+49 (0) 521 106 67533, simon.ladwig@uni-bielefeld.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06897553, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.