BACKGROUND: Psychological responses have been reported for some patients after the insertion of an implantable cardioverter defibrillator (ICD). This study tested the effects of a psychoeducational intervention on anxiety, depressive symptoms, functional status, and health resource use during the first year after ICD implantation. METHODS:ICD patients (n = 246) were randomized to usual care (UC), group (GRP), or telephone counseling (TC) intervention that included education, symptom management, and coping skill training. Participants were 58 +/- 11 years, 73% men, and 23% minorities. Anxiety (State-Trait Anxiety Inventory [STAI]), depressive symptoms (Beck Depression Inventory II [BDI-II]), and functional status (Duke Activity Status Inventory [DASI]) were measured at baseline and after 1, 3, 6, and 12 months. Health resource use and disability days were tracked. Analyses were repeated-measures analysis of covariance to assess Group x Time effects,chi(2)for percentage with clinically significant anxiety and depression at each time point, and logistic regression. RESULTS: All groups experienced decreased anxiety and depressive symptoms over the 12 months; GRP intervention had lower STAI (P = 0.03) than UC at 3 months. Logistic regression revealed group differences for predicted probability of having depressive symptoms at 12 months (UC = 0.31, GRP = 0.17, TC = 0.13, P = 0.03). UC had greater calls to providers at 1 and 6 months (P < 0.05) and more sick/disability days at 12 months (P = 0.01) than intervention groups. CONCLUSIONS: A psychoeducational intervention reduced anxiety and depressive symptoms early after ICD implant, lowered probability of depressive symptoms at 1 year, and decreased disability days/calls to providers. These findings support further study and clinical use of both group and telephone interventions to yield better psychological outcomes after ICD implant.
RCT Entities:
BACKGROUND: Psychological responses have been reported for some patients after the insertion of an implantable cardioverter defibrillator (ICD). This study tested the effects of a psychoeducational intervention on anxiety, depressive symptoms, functional status, and health resource use during the first year after ICD implantation. METHODS:ICDpatients (n = 246) were randomized to usual care (UC), group (GRP), or telephone counseling (TC) intervention that included education, symptom management, and coping skill training. Participants were 58 +/- 11 years, 73% men, and 23% minorities. Anxiety (State-Trait Anxiety Inventory [STAI]), depressive symptoms (Beck Depression Inventory II [BDI-II]), and functional status (Duke Activity Status Inventory [DASI]) were measured at baseline and after 1, 3, 6, and 12 months. Health resource use and disability days were tracked. Analyses were repeated-measures analysis of covariance to assess Group x Time effects,chi(2)for percentage with clinically significant anxiety and depression at each time point, and logistic regression. RESULTS: All groups experienced decreased anxiety and depressive symptoms over the 12 months; GRP intervention had lower STAI (P = 0.03) than UC at 3 months. Logistic regression revealed group differences for predicted probability of having depressive symptoms at 12 months (UC = 0.31, GRP = 0.17, TC = 0.13, P = 0.03). UC had greater calls to providers at 1 and 6 months (P < 0.05) and more sick/disability days at 12 months (P = 0.01) than intervention groups. CONCLUSIONS: A psychoeducational intervention reduced anxiety and depressive symptoms early after ICD implant, lowered probability of depressive symptoms at 1 year, and decreased disability days/calls to providers. These findings support further study and clinical use of both group and telephone interventions to yield better psychological outcomes after ICD implant.
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