Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Outcome of Treatment of Traumatised Refugees With Trauma-Focused Cognitive Behavioural Therapy and / or Antidepressants - a Randomised Controlled Trial
Brief Summary: The purpose of the study is to investigate the effect of treatment of traumatized refugees with a diagnosis of Post-Traumatic Stress Disorder (PTSD). The existing evidence point towards antidepressants of the type SSRI and trauma-focused cognitive Behavioural Therapy being the most effective treatments of PTSD, but very little evidence of treatment effects exist for the group of multitraumatized refugees. This study therefore seeks to investigate the treatment effect of 6 months drug therapy with antidepressants (Sertraline and/ or Mianserine) and/or trauma-focused cognitive behavioral therapy. A total of 200 individual will undergo treatment. They will be randomized to 4 different groups: antidepressants, psychotherapy, a combination og drug and psychotherapy and a waiting list. Outcome measures include symptoms, life quality and function. Patients with a diagnosis of drug abuse or psychosis will not be included. The hypothesis is that a combination of antidepressants and psychotherapy will be more effective than either of the two treatment regimes on their own.


Options:
A: Arm Label: CBT no choice; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Cognitive behavioral therapy (CBT) | Arm Label: CBT choice; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Cognitive behavioral therapy (CBT) | Arm Label: sertraline no choice; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sertraline | Arm Label: sertraline choice; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sertraline | Intervention Type: DRUG; Name: Sertraline; Assigned to Arm(s): sertraline choice, sertraline no choice | Intervention Type: BEHAVIORAL; Name: Cognitive behavioral therapy (CBT); Assigned to Arm(s): CBT choice, CBT no choice
B: Arm Label: N-Acetylcysteine; Type: EXPERIMENTAL; Interventions: Drug: N-acetylcysteine | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: N-acetylcysteine; Assigned to Arm(s): N-Acetylcysteine | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: psychotherapy; Type: EXPERIMENTAL; Interventions: Behavioral: trauma-focused cognitive behavioural therapy | Arm Label: Drug; Type: EXPERIMENTAL; Interventions: Drug: Sertraline | Arm Label: Waiting list; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Combination; Type: EXPERIMENTAL; Interventions: Drug: Sertraline, Behavioral: trauma-focused cognitive behavioural therapy | Intervention Type: DRUG; Name: Sertraline; Assigned to Arm(s): Combination, Drug | Intervention Type: BEHAVIORAL; Name: trauma-focused cognitive behavioural therapy; Assigned to Arm(s): Combination, psychotherapy
D: Arm Label: GR205171; Type: EXPERIMENTAL; Interventions: Drug: NK1 Antagoist (GR205171), Procedure: Psychophysiology (Trauma Script), Procedure: Psychophysiology (Verbal Threat), Procedure: Psychophysiology (Fear Conditioning), Procedure: Psychophysiology (Affective Modulation), Procedure: Psychophysiology (Heart rate variability), Procedure: Lumbar Puncture, Procedure: 24-hour plasma sampling, Procedure: MRI | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Procedure: Psychophysiology (Trauma Script), Procedure: Psychophysiology (Verbal Threat), Procedure: Psychophysiology (Fear Conditioning), Procedure: Psychophysiology (Affective Modulation), Procedure: Psychophysiology (Heart rate variability), Procedure: Lumbar Puncture, Procedure: 24-hour plasma sampling, Procedure: MRI | Intervention Type: DRUG; Name: NK1 Antagoist (GR205171); Assigned to Arm(s): GR205171 | Intervention Type: PROCEDURE; Name: Psychophysiology (Trauma Script); Assigned to Arm(s): GR205171, placebo | Intervention Type: PROCEDURE; Name: Psychophysiology (Verbal Threat); Assigned to Arm(s): GR205171, placebo | Intervention Type: PROCEDURE; Name: Psychophysiology (Fear Conditioning); Assigned to Arm(s): GR205171, placebo | Intervention Type: PROCEDURE; Name: Psychophysiology (Affective Modulation); Assigned to Arm(s): GR205171, placebo | Intervention Type: PROCEDURE; Name: Psychophysiology (Heart rate variability); Assigned to Arm(s): GR205171, placebo | Intervention Type: PROCEDURE; Name: Lumbar Puncture; Assigned to Arm(s): GR205171, placebo | Intervention Type: PROCEDURE; Name: 24-hour plasma sampling; Assigned to Arm(s): GR205171, placebo | Intervention Type: PROCEDURE; Name: MRI; Assigned to Arm(s): GR205171, placebo

Answer: C