Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effectiveness of the First French Psychoeducational Program on Unipolar Depression: Study Protocol for a Randomized Controlled Trial.
Brief Summary: Background. Major Depressive Disorder (MDD) is highly prevalent and was associated with greater morbidity, mortality (including suicide), and healthcare costs. By 2030, MDD will become the leading cause of disability in high-income countries. Notably, among patients with a previous experience of a major depressive episode, it was indeed estimated that up to 85% of those patients will suffer from relapse. Two main factors were associated with a significantly higher risk of relapse: poor medication adherence and low self-efficacy in disease management. Interestingly, these issues could become the targets of psychoeducational programs for chronic diseases. Indeed psychoeducational program for depression are recommended in international guidelines, but have not yet been proposed in France.

Methods/Design: The investigators propose to evaluate the first French psychoeducational program for depression named "ENVIE" in a multicenter randomized controlled trial. Its aim is to educate patients on the latest knowledge on depression and effective treatments through didactic and interactive sessions. Patients will experiment the latest innovating psychological skills (from acceptance and commitment therapy) to cope with depressive symptoms and maintain motivation in behavioral activation. In total, 332 unipolar non-chronic (\< 2 years) outpatients with moderate to severe depression, without psychotic features, will be randomly allocated to the add-on ENVIE program (N=166) or to a waiting list (N=166). The follow-up will last 15 months and include 5 assessment visits (enrollment, 3, 6, 9, 12, 15 months).

Discussion. If the proposed trial shows the effectiveness of the intervention, but also an increased remission rate in depressed outpatients at 15-months post-inclusion, in addition to improved treatment adherence in patients, it will further promotes arguments in favor of a wide dissemination of psychoeducational programs for depression.


Options:
A: Arm Label: Control group; Type: OTHER; Interventions: Other: Treatment as usual | Arm Label: Interventional group; Type: EXPERIMENTAL; Interventions: Behavioral: ENVIE psychoeducational program | Intervention Type: OTHER; Name: Treatment as usual; Assigned to Arm(s): Control group | Intervention Type: BEHAVIORAL; Name: ENVIE psychoeducational program; Assigned to Arm(s): Interventional group
B: Arm Label: CBASP; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Cognitive Behavioral Analysis System of Psychotherapy | Arm Label: SYSP; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: System of Supportive Psychotherapy | Intervention Type: BEHAVIORAL; Name: Cognitive Behavioral Analysis System of Psychotherapy; Assigned to Arm(s): CBASP | Intervention Type: BEHAVIORAL; Name: System of Supportive Psychotherapy; Assigned to Arm(s): SYSP
C: Arm Label: Cognitive therapy plus medications; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Therapy, Drug: Medications | Arm Label: Medications alone; Type: EXPERIMENTAL; Interventions: Drug: Medications | Intervention Type: BEHAVIORAL; Name: Cognitive Therapy; Assigned to Arm(s): Cognitive therapy plus medications | Intervention Type: DRUG; Name: Medications; Assigned to Arm(s): Cognitive therapy plus medications, Medications alone
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Fluoxetine, Drug: Citalopram | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Venlafaxine | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: Fluoxetine, Behavioral: Cognitive Behavioral Therapy (CBT), Drug: Citalopram | Arm Label: 4; Type: EXPERIMENTAL; Interventions: Drug: Venlafaxine, Behavioral: Cognitive Behavioral Therapy (CBT) | Intervention Type: DRUG; Name: Fluoxetine; Assigned to Arm(s): 1, 3 | Intervention Type: DRUG; Name: Venlafaxine; Assigned to Arm(s): 2, 4 | Intervention Type: BEHAVIORAL; Name: Cognitive Behavioral Therapy (CBT); Assigned to Arm(s): 3, 4 | Intervention Type: DRUG; Name: Citalopram; Assigned to Arm(s): 1, 3

Answer: A