About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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 design
Single group
Treatments tested in this trial
ACT-based group therapy
BehavioralACT-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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
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.
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.
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.
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.
Other outcomes
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.
Sponsors and contacts
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