Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT06777693
Eligibility Criteria:
Inclusion Criteria:
* Clinically significant symptoms of anxiety or depression based on self-report and clinical interview
* Score on the MMSE-NR above 26 and competent to give informed consent as evaluated by a structural clinical assessment
* Stable use of psychotropic medication for the last month. Periodic use of z-hypnotics is not exclusion criteria but will be restricted to a limited and pre-planned dosage per week. Stabilization of psychotropic medication can be offered to eligible patients before participation.
* Prepared to share their challenges and work on maladaptive emotion regulation strategies in a group setting.
* Able to attend most sessions.
Exclusion Criteria:
* Conditions requiring specialized treatment such as active psychosis and/or mania, untreated or unstable bipolar disorder, psychosis spectrum disorders or severe depressive episode
* Acutely increased risk of suicide or deliberate self-harm
* Dementia or amnestic mild cognitive impairment
* Substance abuse including psychoactive drugs
* Habitual use of prescribed anxiolytics or opiods. Help with gradual reduction and elimination before inclusion in treatment will be offered to potential participants
* Uncorrected hearing loss
* Symptoms of personality disorders that hinder participation in the group
* Simultaneously participating in other psychotherapy
* Living with ongoing highly social burden where greater flexibility in treatment is needed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT06777693
Study Brief:
Protocol Section:
NCT06777693