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Trauma & Control: Self-Regulation of Brain Networks in PTSD

Trauma & Control: Self-Regulation of Brain Networks in PTSD - TraumaCtrl

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52214
Enrollment
32
Registered
2022-02-23
Start date
2022-01-01
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Posttraumatic stress disorder PTSD

Interventions

None listed

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: PTSD symptoms, according to DSM-5 criteria, as noted by participant's clinician

Exclusion criteria

Exclusion criteria: • History of episode of psychotic or manic symptoms. • Daily intake of benzodiazepines, or otherwise irregular intake of benzodiazepines (*when needed*) but unable to withhold intake from the day prior to each test session until the end of the each test session. An exception is made for low doses of short-acting benzodiazepines that are prescribed for insomnia (i.e. as sleep medication). • A relevant neurological disorder (e.g., stroke, epilepsy, Multiple Sclerosis) or severe physical disorder which is likely to impact assessment procedures or results. • Reports to be unable or unwilling to withhold recreational drug use and limit alcohol use to maximally two units per day from the day prior to each test session until the end of the each test session. • Reports to be unable or unwilling to discuss frequency and timing of smoking during and around study procedures, and adhere to an agreed smoking schedule (personally adjusted to balance feasibility, participant needs and reliability of study outcomes). • General learning disability, or known to have intelligence Quotient (IQ) 250 Kg. • For women: pregnancy • Contraindications for MRI scanning (e.g., pacemaker, implanted metal parts, metal in or around the body, deep brain stimulation, severe claustrophobia).

Design outcomes

Primary

MeasureTime frame
The primary outcome of the study is the behavioural effect of the application of self-regulation strategies learned from neurofeedback training on suppression-induced forgetting in the cognitive task. We expect that PTSD patients can apply learned self-regulation strategies to improve memory suppression.

Secondary

MeasureTime frame
Secondary outcome measures include an assessment of self-regulation performance based on fMRI data, as well as effects of the application self-regulation strategies on daily EMA survey outcomes.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)