CALM Therapy for Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Depression+1 More
CALM Therapy - Behavioral
Eligibility
18+
All Sexes
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Study Summary

This study is evaluating whether a type of therapy called CALM can help people with a primary malignant brain tumor.

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Eligible Conditions

  • Depression

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether CALM Therapy will improve 4 secondary outcomes in patients with Depression. Measurement will happen over the course of baseline compared at 3 month.

Month 6
reduction of anxiety score using the Death and Dying Distress Scale (DADDS)
Month 3
reduction of depressive symptoms using the PROMIS-Depression scale in PBT participants
reduction of depressive symptoms using the PROMIS-Depression scale in PCNST participants
baseline to 6 months
feasibility of implementing CALM remotely

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Arm 1
1 of 1
Experimental Treatment

This trial requires 100 total participants across 1 different treatment group

This trial involves a single treatment. CALM Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Arm 1
Behavioral
Remote CALM therapy for participants with newly or recurrent PCNST

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 and 6 months compared to baseline
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 and 6 months compared to baseline for reporting.

Closest Location

National Institutes of Health Clinical Center - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You are an adult and you are English-speaking. show original
Subjects must be enrolled on the Neuro-Oncology Branch Natural History Study 16C0151. show original
Subjects with histological or imaging confirmation of PCNST who are undergoing standard of care or experimental treatment.
Subjects who have a life expectancy of at least 3 months from time of study entry to allow for participation in the 3 required sessions.
The ability of the subject to understand and the willingness to sign a written informed consent document as determined by the assessment of the treating physicians.

Patient Q&A Section

What is the latest research for brain cancer?

"There is new discoveries in brain cancer epidemiology, prognostic markers, tumor biology, and new targeted treatments as well as pharmacotherapy (e.g., the anti-epidermal growth factor receptor protein inhibitors)." - Anonymous Online Contributor

Unverified Answer

Can brain cancer be cured?

"Although a cure is unlikely, the potential value of a cure in the treatment of [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer) is of interest to many patients and clinicians. For those who have had a resection or radiotherapy, the probability of cure is high. For patients who are untreated, a cure is only possible with significant surgery." - Anonymous Online Contributor

Unverified Answer

How many people get brain cancer a year in the United States?

"Although the number of current smokers is expected to decrease significantly and the prevalence of other risk factors to decrease by about 15%, there is a trend toward an increase in the number of new cases of brain cancer annually. About 13% of the newly diagnosed cases will be due to malignant neoplasms of the brain or central nervous system." - Anonymous Online Contributor

Unverified Answer

What is brain cancer?

"Brain cancer is a rare disease. Around 2.5% of all cancers occur in the brain. The most common form, glioma, is the most lethal type of brain tumor. Symptoms depend on which part of the brain the tumor arises from.\n" - Anonymous Online Contributor

Unverified Answer

What causes brain cancer?

"Brain cancer is most common amongst middle-aged adults and carries a poor prognosis, especially when metastatic. The main risk factors involve the brain but include a variety of insults, including environmental pollutants and genetic mutations.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for brain cancer?

"There are no standard treatments for [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer), but treatment is often based on the stage and specific type of cancer. This can vary significantly between different types of brain tumors and is more predictable with malignant tumours than benign brain tumours." - Anonymous Online Contributor

Unverified Answer

What are the signs of brain cancer?

"Most signs are easily understandable. In the case of head pain or sudden headaches, please get to a hospital. Brain cancer is more likely if your pain/headaches last more than a week. If you have pain or a lump in your neck go to a doctor. A recent unexplained decrease in a person's hearing or vision should be reported to a doctor. An unexplained change in sensation, such as numbness, loss of coordination, or tingling, should be reported to a doctor." - Anonymous Online Contributor

Unverified Answer

How serious can brain cancer be?

"As the number of patients suffering from [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer) increases, the number of deaths from brain cancer will remain fairly constant. Even assuming that the number of new patients is stable, however, the survival rate of brain cancer patients will drop to lower levels and the mortality rate will continue to climb steadily over the next few years. We don’t know how seriously brain cancer will persist in the next few years. We don’t know when or if new drugs or treatments will become available which may help brain cancer patients. We don’t know how long the average patient’s life expectancy from brain cancer will be if none of the existing treatments help." - Anonymous Online Contributor

Unverified Answer

Does brain cancer run in families?

"Brain cancers are not only an orphan disease in some countries and regions. The occurrence of brain cancer differs depending on the genetic background of families. The underlying risk factors for brain cancer development may also differ in different populations. More importantly, the impact of screening and treatment is not the major factor in the reduction in brain cancer incidence." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving calm therapy?

"We need to establish the validity of these findings, including whether other treatments with the reported efficacy also decrease the risk of death and relapse of glioma patients. We should also validate the clinical effectiveness of this intervention using more stringent randomized studies." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets brain cancer?

"Most patients who get [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer) are younger than 60 years old. While the prevalence of cancers in the brain increases with age, only about 5% of brain cancer patients are older than 70. In general, brain cancer occurs at a young age compared to most other cancers. Only about 13% of patients are 70 years old or older. 3. The risk for cancer may be lower for patients with higher education and occupational or recreational activity before diagnosis. This observation is consistent with the finding that a patient diagnosed early in life had a worse survival. Although this correlation may be explained by more aggressive treatment for patients with earlier diagnosis, it raises an intriguing possibility about the pathogenesis of brain cancer." - Anonymous Online Contributor

Unverified Answer

Is calm therapy typically used in combination with any other treatments?

"Results from a recent paper have significant indications of the efficacy of the use of peaceful, peaceful environment, non-stressful work and rest, and calm therapy." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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