PurposeThe family of leukemia patients, due to their caring role, often feel psychological distress. This paper describes the efficacy of a designed family-need-based program on relieving depression, anxiety, and stress of family caregivers of leukemia patients by meeting the specific psychological needs of caregivers.MethodsIn this clinical trial, 64 family caregivers of leukemia patients referring to a medical center in Iran were recruited by convenience sampling and divided into study and control groups randomly. The study group attended a designed need-based program. The control group did not receive the intervention. Stress, anxiety, and depression before, right after, and one month after the intervention in family caregivers were compared using DASS-42. Data were analyzed using descriptive and inferential statistics; the significance level adopted was 5%.ResultsBefore the intervention, the mean score of depression, anxiety, and stress scale in both study and control groups showed no considerable difference (P > 0.05). After the intervention, the mean score of DASS-42 revealed a significant difference between the two groups and the study group did better on outcomes (P < 0.001).ConclusionThis family-need-based program can decrease the level of stress, anxiety, and depression of the family caregivers of leukemia patients and may potentially alleviate the psychological distress of family caregivers over their caring role.Trial registration number: IRCT2013093011895N2. Date of registration: 2014-05-06