The purpose of this study is to determine if any improvements in depressive symptoms are maintained in the medium and longer-term (up to 3 months)
The duration of the study is 3 months Participants enrolled in the Almond Therapy group will have up to 9 in person visits, including the baseline visits, participants will receive Esketamine on 8 of these visits. There are 12 remote therapy sessions conducted via telephone or video, participants will also receive supportive text messages. In addition, participants will have 4 telephone calls from an independent assessor to ask questions about their mental health (MADRS). Participants enrolled in the Treatment as Usual group will have up to 9 in person visits, including the baseline visits, participants will receive Esketamine on 8 of these visits. Participants will continue to receive the therapy their treating physician felt was appropriate at the time of enrolment in the study. In addition, participants will have 4 telephone calls from an independent assessor to ask questions about their mental health (MADRS). Participants will receive intranasal Esketamine 56mg or 84 mg once weekly for 4 weeks and 56 mg or 84 mg once every 2 weeks for 8 weeks as per Product Monograph
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Participants will receive 12 remote session conducted by video or phone. Therapy sessions consist of modules selected using a shared decision making process, tailored so that it is personally meaningful to each participants. Participants will also receive supportive text messages on selective days over the 3 months.
Participants will receive 56 mg or 84 mg once a week for 4 weeks followed by 56 mg or 84 mg once every two weeks for 8 weeks
Participants will continue to received the therapy that their treating physician felt was appropriate at the time of enrolment in the study. These can include cognitive behavioural therapy, supportive psychotherapy or mindfulness, support groups, physical activity or relaxation.
Change in Montgomery Asberg Depression Rating Scale (MADRS)
The MADRS is a clinician rated 10-item scale where individuals score from 0-6 based on the severity of their symptoms with higher scores indicative of greater severity
Time frame: Baseline, Day 26, 54 and 89
Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5
A 20-item self-administered measure that assesses the presence and severity of PTSD symptoms derived from the symptoms of PTSD in DSM-5. Participants will be asked to rate how bothered they have been by each item in the 4 weeks on a 5-point Likert scale ranging from (0=Not at all to 4=Extremely). The PCL-5 is easily scored by summing all of the items for a total symptom severity score ranging between 0-80. Clinically meaningful PTSD symptoms are present if items are rated as a minimum of 2 = "Moderate" or higher.
Time frame: Baseline, Day 26, 54 and 82
Change in Patient Health Questionnaire (PHQ-9)
A 9-item self-administered questionnaire to determine the presence and severity of depression which scores each of the 9 DSM-IV criteria as "0"(not at all), to "3" (nearly everyday
Time frame: Baseline, Day 12, 26, 40, 54, 68 and 82
Change in Generalized Anxiety Disorder Questionnaire (GAD-7)
A 7-item self-administered questionnaire to measure the severity of the levels of anxiety. Each item can be scored 0-3, giving a total score of 0-21.
Time frame: Baseline, Day 12, 26, 40, 54, 68 and 82
Change in Rosenberg Self-Esteem Questionnaire (RSES)
A 10-item self administered questionnaire to measure change in self esteem following psychological intervention. Each item scoring from 1-4, and higher scores indication greater self-esteem
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Time frame: Baseline, Day 26, 54 and 82
Change in Quality of Life 8 Dimensional Questionnaire (AQoL-8D)
Self administered questionnaire measuring quality of life across 8 domains: independent living, happiness, mental health, coping, relationships, self-worth, pain and senses
Time frame: Baseline, Day 26, 54 and 82