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Treatment study psychotrauma: Medication versus psychotherapy. Behandelstudie psychotrauma: Medicatie versus psychotherapie.

The effectiveness of Paroxetine versus Trauma-Focused Cognitive Behavioural Therapy in the treatment of PTSD.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29379
Enrollment
234
Registered
2010-03-01
Start date
2009-09-01
Completion date
Unknown
Last updated
2024-02-28

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

1. Trauma-focused cognitive behavioural therapy (TF-CBT), consisting of 12 weeksly sessions
2. Paroxetine (Seroxat) treatment lasts for 24 weeks. Treatment will be initiated at 20 mg daily for four weeks and can be increased by increments of 10mg/daily each four weeks up to a maximum of 60 m

Sponsors

Academic Medical Center, University of Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with a diagnosis of chronic PTSD (> 3 months); 2. CAPS score of 45 and higher; 3. Male and female, aged 18 years and above; 4. Written informed consent; 5. Eligible for exposure therapy.

Exclusion criteria

Exclusion criteria: 1. Suicidal risk; 2. Presence of any of the following DSM IV diagnoses: Psychotic disorder incl. schizophrenia, a bipolar disorder, depression with psychotic features, or excessive substance related disorder over the past 6 months; 3. Female patients of childbearing potential must have a negative pregnancy test; 4. Primary diagnosis of severe depressive disorder; 5. Presence of primary or co-morbid personality disorder; 6. An organic disorder; 7. Intolerance to paroxetine or any other SSRI, taking psychotropic medications.

Design outcomes

Primary

MeasureTime frame
1. The change in Clinician Administered PTSD Scale (CAPS) at 1 week, 3 months, 6 months, 12 and 18 months after treatment; 2. (Unit) costs associated with an improved PTSD outcome in terms of CAPS scores at 1 week, 3 months, 6 months and 12 and 18 months after treatment.

Secondary

MeasureTime frame
At 1 week, and 3, 6, 12 and 18 months post-intervention the following secondary outcomes will be assessed as well: 1. Other psychopathology; 2. Quality of life; 3. Anxiety and depression and costs; 4. Neurocognitive, neuroimmune and genetic measures.

Contacts

Public ContactM. Olff

Meibergdreef 5, PA3-118

m.olff@amc.uva.nl+31 (0)20 8913662

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)