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The treatment of anxiety and depressive symptoms after acquired brain injury.

Clinical and cost-effectiveness of Acceptance and Commitment Therapy for depression and anxiety after acquired brain injury.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23617
Enrollment
94
Registered
2018-03-26
Start date
2018-08-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired brain injury (ABI), Anxiety, Depression Niet aangeboren hersenletsel (NAH), Angst, Depressie

Interventions

The participants receive Acceptance and Commitment Therapy or psycho-education combined with relaxation training. Both interventions consist of eight sessions which will last 60 till 90 minutes.

Sponsors

Maastricht University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - having sustained any type of stroke or traumatic brain injury which is objectified by a neurologist; - the depression subscale of the Hospital Anxiety and Depression Scale (HADS) is above 7 and/or the anxiety subscale of the HADS is above 7; - being 18 years or older; - stable use of medication (such as antidepressants) for the duration of the study and use of antidepressants should be stable four weeks prior to the beginning of the study; - access to the internet and a computer because treatment materials such as patient videos are shown via the internet; - the Dutch language, cognitive and communicative skills are sufficient to benefit from treatment based on clinical judgement; and - giving informed consent.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - history of brain injury or disease (objectified by neurologist and classified as moderate or severe) or any neurological disorder (such as: idiopathic epilepsy, brain tumor, meningioma, multiple sclerosis, Huntington’s disease, Parkinson’s disease, meningitis, or encephalitis) other than a stroke and traumatic brain injury; - pre-morbid disability as assessed with the Barthel Index (score<19/20); - severe co-morbidity that might affect outcome (e.g., cancer or major psychiatric illnesses for which treatment is given at the moment of inclusion); - ongoing mood and/or anxiety disorder based on the DSM 5 for which pharmacological and/or psychological treatment was necessary during the onset of the brain injury; - attendance in a previous ACT intervention for comparable problems in the year proceeding entry in the current study.

Design outcomes

Primary

MeasureTime frame
Primary outcome measure for clinical effectiveness is the Hospital Anxiety and Depression Scale (HADS) measuring depressive and anxiety symptoms. Primary outcome measure for the cost effectiveness will be the five-dimensional five-level EuroQol (EQ-5D-5L) and a cost-questionnaire specifically designed for this study.

Secondary

MeasureTime frame
Secondary outcome measures are the Depression Anxiety Stress Scale (DASS-21), Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P), Short Form Survey (SF12), Acceptance and Action Questionnaire II (AAQ-II), Acceptance and Action Questionnaire after brain injury (AAQ-ABI), Valued Living Questionnaire (VLQ) and the Cognitive Fusion Questionnaire (CFQ-7).

Contacts

Public ContactJohanne Rauwenhoff

Maastricht University

johanne.rauwenhoff@maastrichtuniversity.nl0433884098

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)