OBJECTIVES: Caregivers's patients with Alzheimer's disease (AD) experience physical and psychical stress due to the caring. This study evaluated the benefits of a Psychosocial Intervention Program (PIP) on caregivers' burden METHODS: A epidemiological, prospective, randomized, multicenter study was conducted by psychiatrists who recruited 115 primary caregivers's of patients with AD (DMS-IV criteria and MMSE score = 10 – 26) and at least 2 impaired instrumental activities of daily living (IADL score) by Lawton & Brody Test. Caregivers were randomized to receive either PIP (intervention group (IG), n=60) or standard care (control group (CG), n=55). PIP consisted on individual sessions (scheduled every 1-2 weeks during 4 months) of teaching strategies to reduce caregiver burnout. Caregivers stress, quality of life (QoL) and perceived health were measured using validated scales (Zarit, SF-36, GHQ-28) at baseline, after a 4-month and a 10-month follow-up period RESULTS: The profile of patient with AD was a 77-years-old woman, with moderate dementia (MMSEscore=18.74) and high impairment of daily living activities (mean IADLscore=2.17). The caregiver profile was a 60-years-old woman, wife or adult daughter, who is being careing for 3 years and care daily time was >12 hours, without refund. Changes in caregiver burden (baseline Zaritscore – final Zaritscore) showed an improvement in the IG (-8.09 points) and a worsening grouping the CG (+2.08 points), with statistically significance (p=0.0083). The IG showed significant improvements in all the well-being perception areas measured by the SF-36scores and significantly lower score in the GHQ-28score (p=0.0004). Caregivers and therapists considered PIP “useful/very useful” in a 97.7% and 88,6 % respectively at the end of PIP, and in a 93,2% and 86,3% at 6 moths after PIP ending. CONCLUSION: Caregivers' psychosocial training can minimize caregiver distress and may help to develop strategies for coping problems. PIP improves QoL and the perceived health of caregivers of patients with AD.