Study Results
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View full resultsBasic Information
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COMPLETED
NA
13 participants
INTERVENTIONAL
2022-03-23
2023-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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CALM
CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone
CALM Intervention
The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints:
* Within one week before initiating the CALM intervention therapy
* Within one week after its completion,
* 3 months after the CALM intervention is complete
* After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components
Interventions
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CALM Intervention
The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints:
* Within one week before initiating the CALM intervention therapy
* Within one week after its completion,
* 3 months after the CALM intervention is complete
* After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components
Eligibility Criteria
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Inclusion Criteria
* At least 2 weeks post-surgical cranial resection or cranial biopsy (if applicable)
* Score \> 20 on the TICS
* Report elevated depression (PHQ-9 score ≥ 10) OR death anxiety symptoms (DADDS score ≥ 15)
* Ability to read, speak, and understand English
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
* Inability to meet with interventionist via an electronic device for telehealth intervention sessions
* Inability to understand and provide informed consent
* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the participant's risk
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Ashlee Loughan, PhD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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References
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Loughan AR, Lanoye A, Willis K, Braun SE, Davies A, Rodin G, Thacker L, Fox A, Kleva C, Zarrella G, Mazzeo S, Svikis D, Swartz L. Managing Cancer and Living Meaningfully in adults with brain metastases: A NIH ORBIT model phase II feasibility and proof-of-concept trial. Neurooncol Pract. 2024 Oct 15;12(2):271-280. doi: 10.1093/nop/npae097. eCollection 2025 Apr.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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MCC-21-18040
Identifier Type: -
Identifier Source: org_study_id
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