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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Waiting List and ACT group therapy | Experimental | Eight weeks of waiting list are followed by eight weeks of ACT group therapy, see study design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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 | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Katja Werheid, Prof | Bielefeld University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuropsychologische Hochschulambulanz Bielefeld | Recruiting | Bielefeld | 33602 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. |
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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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IPD will be available latest six months after completion of data collection, presumably January, 1st, 2027. Data will be deleted after ten years.
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| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D000092862 | Psychological Well-Being |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
| D001523 | Mental Disorders |
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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).
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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) |
| GTS-P Session and GTS-T during the intervention (weekly, after each session), GTS-P Total post-intervention |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |