Behavioral Health Evaluation and Intervention Program for Patients Undergoing Craniotomy

Study Purpose

This is a single center non-randomized, single-arm feasibility trial of the implementation of virtual behavioral health counseling sessions alongside standard-of-care treatment.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age 18 years of age or older. 2. Able to understand study procedures and to comply with them for the entire length of the study. 3. Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it. 4. Documented diagnosis of a brain tumor. 5. PHQ-9 screening score of >= 5. 6. No prior surgical intervention, other than biopsy, for brain tumor. 7. Scheduled for craniotomy for brain tumor resection.

Exclusion Criteria:

1. Contraindication to any study-related procedure or assessment. 2. PHQ-9 scores of: 1. < 5. 2. >= 20. 3. >= 1 point on Question number 9

- thoughts of self-harm or suicidality.

3. Require urgent or emergent surgical intervention or admission to the hospital prior to the scheduled surgery. 4. Prior surgical intervention for brain tumor. 5. Prior suicide attempt. 6. Prior hospitalization for psychiatric treatment. 7. Currently undergoing mental or behavioral health-related counseling or psychotherapy, other than currently taking an anti-depressant medication.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05789862
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of California, San Francisco
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Shawn Hervey-Jumper, MD
Principal Investigator Affiliation	University of California, San Francisco
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Tumor

Additional Details

PRIMARY OBJECTIVE:

I. Determine the feasibility of implementing behavioral health counseling sessions alongside standard of care treatment for brain tumor participants scheduled to undergo craniotomy for treatment.

SECONDARY OBJECTIVE:

I. To assess the acceptance of virtual behavioral health counseling sessions during the initial management of a newly diagnosed brain tumor.

II. To explore the rates of pre- and post-surgical mental health disorders in participants newly diagnosed with a brain tumor.

III. To explore pre- and post-surgical quality of life with virtual behavioral health counseling sessions during the initial management of a newly diagnosed brain tumor.

OUTLINE: Participants will be given the opportunity to participate in virtual behavioral health counseling sessions at three time points relative to the scheduled tumor resection operation. All participants will receive questionnaires related to mental health, quality of life, and satisfaction with the study intervention. Participants who do not want to participate in the counseling sessions will be provided the option to complete the assessment tools related to mental health and quality of life only. Participants will be assessed over the course of 9 months related to standard-of-care treatment at the following time points: before the operation (baseline), 4 to 6 weeks following the operation, and 6 to 9 months following the operation. At each time point, the participants will fill out the questionnaires and engage in the virtual counseling sessions.

Arms & Interventions

Arms

Experimental: Virtual behavioral health

Participants will be assessed at 3 time points over the course the standard-of-care treatment before and after a scheduled craniotomy. At each time point, the participants will be asked to complete the questionnaires and engage in virtual counseling sessions.

Interventions

Behavioral: - Counseling Sessions

Virtual sessions

Behavioral: - Quality of Life Questionnaires

Self administered questionnaires

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California, San Francisco, San Francisco, California

Status

Address

University of California, San Francisco

San Francisco, California, 94122

Site Contact

Jacob Young, MD

[email protected]

877-827-3222