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Table 2 Protocol – eligibility criteria

From: Evaluation of a spirituality informed e-mental health tool as an intervention for major depressive disorder in adolescents and young adults – a randomized controlled pilot trial

Inclusion criteria:

• 13 to 24 years of age

• Suspicion he/she might be suffering from depression

• Stabilized on anti-depressants, if applicable

• Currently under the care of a health care professional

• Agreeable to having the study team contact the health professional prior to enrollment, at completion of study and if it was evident additional support was needed for the participant during the course of the study

• Interested in study participation

Exclusion criteria:

• High suicide risk

• History of multiple suicide attempts

• Recent death in the family

• History of Bipolar disorder, Psychotic disorder or Psychotic episodes

• Personality disorder traits that may impede participation in the study

• History of Attention Deficit Hyperactivity disorder (ADHD) (permitted if stabilized for at least 2 months on a long-acting medication, signs/symptoms/behaviours are well controlled, and participant agrees to continue)

• DSM-IV-TR diagnosis of substance dependence (except nicotine and caffeine) within the past 12-months

• Uncontrolled medical conditions in the last 3 months (assessed by qualified physician)

• Change in use of pharmacotherapy or herbal treatment for depression (St. John’s Wort) in the last 3 months OR during the first 2 months of trial participation (Eligible if no change in medication or dosage in the last 3 months and it is foreseeable that their current treatment will continue unchanged for the first 2 months of participation)

• Change in the use of medications that have mood altering effects in the last 3 months OR during the first 2 months of trial participation

• History of treatment resistance to ≥ 2 antidepressant medications when treated for an adequate period with a therapeutic dose

• Patients currently undergoing a specific psychotherapeutic treatment that has been shown to be effective for depression (such as Cognitive Behavioral Therapy (CBT) or Interpersonal Therapy (IPT)) or planning to start such therapy in the next two months