Brain imaging in Posttraumatic Stress Disorder (PTSD): effects of paroxetine and Trauma-Focused Cognitive Behavioural Therapy (TF-CBT)

Brain imaging in Posttraumatic Stress Disorder (PTSD): effects of paroxetine and Trauma-Focused Cognitive Behavioural Therapy (TF-CBT) - Brain imaging in PTSD, effects after treatment

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33322

Enrollment

Registered

2009-11-24

Start date

2009-10-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

PTSD en stress disorder

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: CAPS score of * 50 (only for PTSD patients) Male and female, aged 18 years and above Written informed consent Eligible for exposure therapy Eligible for fMRI (no metals, pacemaker or claustrophobia)

Exclusion criteria

Exclusion criteria: Suicidal risk Presence of any of the following DSM IV diagnoses, at present or in the past: psychotic disorder incl. schizophrenia, a bipolar disorder, depression with psychotic features, a panic disorder with or without agoraphobia or excessive substance related disorder over the past 6 months Primary diagnosis of severe depressive disorder Presence of primary or co-morbid personality disorder An organic disorder Taking any psychotropic medications at present

Design outcomes

Primary

Measure	Time frame
Main study parameter included is the difference in structural and functional imaging results in patients with PTSD versus controls. Secondly, effective versus non-effective therapy (TF-CBT and paroxetine) will be compared with regard to structural and functional differences. Furthermore, neuro-immune, neuro-endocrine and neurocognitive data will be associated with structural and functional differences in patients and controls. Functional differences in the small subgroup of PTSD-patients receiving biofeedback as an adjunct to TF-CBT will be compared to PTSD-patients receiving regular TF-CBT as part of the main treatment study.	—

Measure

Time frame

Main study parameter included is the difference in structural and functional imaging results in patients with PTSD versus controls. Secondly, effective versus non-effective therapy (TF-CBT and paroxetine) will be compared with regard to structural and functional differences. Furthermore, neuro-immune, neuro-endocrine and neurocognitive data will be associated with structural and functional differences in patients and controls. Functional differences in the small subgroup of PTSD-patients receiving biofeedback as an adjunct to TF-CBT will be compared to PTSD-patients receiving regular TF-CBT as part of the main treatment study.

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Countries

Netherlands

Outcome results