TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors
M.D. Anderson Cancer Center
Summary
This clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and/or anxiety.
Description
Primary Objective: To examine the feasibility, safety, effect size estimates of psilocybin-assisted psychotherapy for cancer survivor patients with depression and/or anxiety. Feasibility will be measured as: At least 20% of eligible patients consent (inclusion rate), at least 60% of consented patients completing the two doses of treatment (treatment completion rate), and at least 80% and 65% consenting patients completing assessments at the 2- and 6-month follow-ups (adherence rates), respectively. Secondary Objectives: 1. Determine whether psilocybin-assisted psychotherapy improves measure…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subjects must have solid or hematological malignancy that does not involve the brain. 2. Documentation of current malignancy that was treated and the patient has no evidence of disease in the previous 6 months 3. Age ≥ 18 years. 4. Have a DSM-V psychiatric diagnosis, as determined by the SCID (Structured Clinical Interview for DSM), of one or more of the following Axis I psychiatric disorders that is judged to have been precipitated by the psychological stress of the cancer diagnosis: Generalized Anxiety Disorder; Acute Stress Disorder; Posttraumatic Stress Disorder; Ma…
Interventions
- DrugPsilocybin
Participants will recive treatment by mouth on an outpatient basis.
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas