This is a pilot clinical trial to assess the feasibility, safety, and preliminary efficacy of ketamine-assisted group therapy for Spanish-speaking adults with depression
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
Ketamine-assisted psychotherapy delivered in a group format
Massachusetts General Hospital, Chelsea
Chelsea, Massachusetts, United States
RECRUITINGEvaluate feasibility of a culturally adapted group-based ketamine intervention for Spanish- speaking adults with depression in a community setting
(a) Assess the attendance and adherence rates of participants to the group-based ketamine intervention sessions; (b) Evaluate the feasibility of delivering the intervention sessions as planned, including the preparatory, dosing, and integration sessions; (c) Explore the perceptions and experiences of Spanish-speaking participants regarding the intervention.
Time frame: 1 week post-intervention
To assess the safety of a ketamine-assisted group psychotherapy intervention for Spanish-speaking participants with depression in a community setting.
(a) assess safety as obtained through vital monitoring; heart-rate variability (HRV) monitoring, EKG, as measured by a Fitbit. (b) evaluate physical and psychological adverse effects at each study visit.
Time frame: 1 week post-intervention
Investigate the preliminary efficacy of the group-based ketamine intervention on psychiatric symptoms, wellbeing, and health behaviors among Spanish-speaking participants with depression.
(a) Assess changes in psychiatric symptom scales pre- and post-intervention using validated assessment tools. (b) Measure changes in wellbeing (social wellbeing, personal wellbeing, spiritual health) pre- and post- intervention through self-report scales. Explore shifts in health behaviors pre-and post-intervention, through self-report and accelerometry measures.
Time frame: 1 and 12 weeks post-intervention
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