NCT01691378 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Brenner LA, Forster JE, Hoffberg AS, Matarazzo BB, Hostetter TA, Signoracci G, Simpson GK
Window to Hope: A Randomized Controlled Trial of a Psychological Intervention for the Treatment of Hopelessness Among Veterans With Moderate to Severe Traumatic Brain Injury. J Head Trauma Rehabil. 2018 Mar/Apr;33(2):E64-E73. doi: 10.1097/HTR.0000000000000351.
Matarazzo BB, Hoffberg AS, Clemans TA, Signoracci GM, Simpson GK, Brenner LA
Cross-cultural adaptation of the Window to Hope: a psychological intervention to reduce hopelessness among U.S. veterans with traumatic brain injury. Brain Inj. 2014;28(10):1238-47. doi: 10.3109/02699052.2014.916419. Epub 2014 Jun 19.

Window to Hope-Evaluating a Psychological Treatment for Hopelessness Among Veterans With Traumatic Brain Injury

Clinical trial NCT01691378 - References