Please select the eligibility criteria that correspond 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: Inclusion Criteria:

* aged 18-65 years
* with a main diagnosis of non-psychotic non-chronic (\<2 years) major depressive episode (DSM-IV criteria) of moderate to severe intensity (Montgomery Asberg Depression Scale score \> 24)
* taking at least one antidepressant
* able to speak, read and understand French
* and able to give written informed consent

Exclusion Criteria:

* current psychotic features
* duration of current depressive episode \>2 years
* current organic mental disorder or mental retardation, or severe comorbid medical condition
* lifetime history of schizophrenia, or schizoaffective or bipolar disorder, manic, hypomanic, or mixed episodes according to DSM-IV criteria
* sensory or cognitive disabilities
* having a relationship or being employed by the sponsor or investigator.
* We will also exclude patients who are planning a long stay outside the region preventing compliance with the scheduled visits, and subjects participating in another trial.
B: Inclusion Criteria:

1. DSM-IV criteria for a current episode of chronic MDD, MDD superimposed on a pre-existing dysthymic disorder or recurrent MDD with incomplete remission between episodes in a patient with a current MDD and a total duration of at least 2 years.
2. Early onset of the disorder according to DSM-IV (onset before the age of 21)
3. Age between 18 and 65
4. A score of at least 20 on the 24-item HRSD at screening and, after a 2-week drug-free period, at baseline
5. Fluent in German language
6. Provide informed consent

Exclusion Criteria:

1. Acute risk for suicide (as opposed to suicidal thoughts) assessed according to clinical practice guidelines. Suicidal patients are eligible, as long as outpatient treatment is deemed safe by the clinician.
2. A history of psychotic symptoms, bipolar disorder, or organic brain disorders
3. A primary diagnosis of another axis I disorder including anxiety disorders (e.g. Posttraumatic Stress Disorder), or any severe substance-related abuse or dependence disorder as evaluated with the SCID-I
4. Antisocial, schizotypical, or borderline personality disorder (SCID-II);
5. Severe cognitive impairment
6. Absence of a response to previous adequate trial of CBASP, and/or SYSP
7. Other ongoing psychotherapy or medication
8. A serious medical condition (i.e. a history of seizures, severe head trauma, stroke or heart attack within six months before the study began)
C: Inclusion Criteria:

* Recurrent or chronic major depressive disorder

Exclusion Criteria:

* Current diagnosis of psychotic affective disorder
* History of nonaffective psychotic disorder
* Substance dependence last three months requiring detox
* Schizotypal, antisocial, or borderline personality disorder
D: * between the ages of 12 and 18 years 11 months
* currently in treatment for depression
* taking Prozac,Zoloft, Luvox, Lexapro, Celexa or Paxil (Oregon and Rhode Island sites only)
* still feeling depressed

Answer: A