Augmented cognitive behavioral therapy for post stroke depressive symptoms: a randomized controlled trial

OBJECTIVE: To evaluate the effectiveness of individually tailored cognitive behavioral therapy (CBT) for reducing depressive symptoms with or without anxiety post stroke.

DESIGN: Multi-center, assessor-blinded, randomized controlled trial.

SETTING: Six ambulatory rehabilitation settings in The Netherlands.

PARTICIPANTS: Patients who had a Hospital Anxiety and Depression Scale - subscale Depression (HADS-D) score > 7 at least three months post stroke.

INTERVENTIONS: Sixty-one participants were randomly allocated to either augmented CBT or computerized cognitive training (CCT). The CBT intervention was based on the principles of recognizing, registering, and altering negative thoughts and cognitions. CBT was augmented with goal-directed real-life activity training given by an occupational or movement therapist.

MAIN OUTCOME MEASURES: HADS-D was the primary outcome and measures of participation and quality of life were secondary outcomes. Outcome measurements were performed at baseline, directly post treatment, and at four and eight months follow-up. Analysis was performed with linear mixed models using group (CBT vs CCT) as between-subjects factor and time (4 assessments) as within-subjects factor.

RESULTS: Mixed model analyses showed a significant and persistent time effect for HADS-D (MD:-4.6, 95%CI=-5.7;-3.75, p<0.00) as well as for participation and quality of life in both groups. There was no significant group x time effect for any of the outcome measures.

CONCLUSIONS: Our augmented CBT intervention was not superior to computerized cognitive training for the treatment of mood disorders after stroke. Future studies should determine whether both interventions are better compared to natural history.