Behavioral Health Evaluation and Intervention Program for Patients Undergoing Craniotomy

NCT ID: NCT05789862

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Brain Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Counseling Sessions

Intervention Type: BEHAVIORAL

Virtual sessions

Quality of Life Questionnaires

Intervention Type: BEHAVIORAL

Self administered questionnaires

Interventions

Counseling Sessions

Virtual sessions

Intervention Type: BEHAVIORAL

Quality of Life Questionnaires

Self administered questionnaires

Intervention Type: BEHAVIORAL

Other Intervention Names

Behavioral health counseling sessions; Health related quality of life assessment (HRQoL)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clarity Squared Behavioral, Inc

UNKNOWN

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shawn Hervey-Jumper, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Other Identifiers

NCI-2023-02189

Identifier Type: REGISTRY

Identifier Source: secondary_id

211013

Identifier Type: -

Identifier Source: org_study_id