NCT01168284 - 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)

Astin JA, Beckner W, Soeken K, Hochberg MC, Berman B
Psychological interventions for rheumatoid arthritis: a meta-analysis of randomized controlled trials. Arthritis Rheum. 2002 Jun 15;47(3):291-302.
Chesney MA, Neilands TB, Chambers DB, Taylor JM, Folkman S
A validity and reliability study of the coping self-efficacy scale. Br J Health Psychol. 2006 Sep;11(Pt 3):421-37.
Hall S, Reid E, Ukoumunne OC, Weinman J, Marteau TM
Brief smoking cessation advice from practice nurses during routine cervical smear tests appointments: a cluster randomised controlled trial assessing feasibility, acceptability and potential effectiveness. Br J Cancer. 2007 Apr 10;96(7):1057-61.

A Coping Effectiveness Training Intervention for Caregivers of Children With Autism Spectrum Disorders: A Feasibility Study

Clinical trial NCT01168284 - References