Clinical trial · Interventional
Behavioral Health Evaluation and Intervention Program for Patients Undergoing Craniotomy
A Comprehensive Behavioral Health Evaluation and Intervention Program for Patients Undergoing Craniotomy for Brain Tumor
NCT05789862CI-TRIAL-00094288withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor portfolio adjustment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Counseling Sessions | Behavioral | — | UNRESOLVED |
| Quality of Life Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Virtual behavioral health
- description
- 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.
- interventionNames
- Behavioral: Counseling Sessions
- Behavioral: Quality of Life Questionnaires
Primary outcomes (1)
- measure
- Proportion of participants who completed program
- timeFrame
- Up to 9 months
- description
- The proportion of enrolled patients that complete all three virtual behavioral health counseling sessions from time of study enrollment to the final behavioral health counseling session, approximately 6-9 months following the participants surgical operation, will be reported.
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.