Background: Although there is an evidence to support the efficacy of cognitive behavioral therapy (CBT) in improving quality of life and decreasing psychological distress in patients with cardiovascular diseases but involving patient’s and relatives in the CBT and its effect on patient’s general health, has not been evaluated.

Aim: The aim was to determine whether involving the relatives in CBT for patients with Atrial Fibrillation (AF) enhances treatment outcomes relative to treatment as usual group (TAU).

Method: In a randomized controlled trial, 78 patients diagnosed with AF were randomly assigned to experimental (EXP) or TAU groups. In the EXP group, patients and relative participated in a 6-week program while the patient in the TAU group received standard care. Short Form 36(SF-36), Hospital Anxiety and Depression Scale (HADS),Euro-QoL 5-Dimension Self-Report Questionnaire (EQ-5D) and Sense of Coherence (SOC-13) were completed at  baseline and at 12-month follow-up. 

Results: In all 78 patients completed the assessment at 12 months. The two groups were similar for sociodemographic and clinical variables at baseline. The EXP group reported significantly higher scores in EQ-5D (F= 6.18, p = 0.01) and SOC (F= 4.15, p = 0.04) than TAU group. Compared with TAU group, patients in EXP group reported significantly lower depression (F= 4.58, p = 0.04). Thirteen percent of Indirect effect of the intervention on improving patient’s quality of life in the EXP group was related to the SOC improvement (z = 11.83, p < .01).

Conclusions: This study provides evidence that patients and their relatives’ involvement is more effective in improving quality of life and decreasing psychological distress than those who receiving standard care. Our results also indicate that interventions should initially focus on increasing patient’s sense of coherence.