Background: Dignity therapy is a brief psychotherapy developed for patients living with a life-limiting illness. Objective: To determine the influence of dignity therapy on depression and anxiety in inpatients with a terminal illness and experiencing a high level of distress in a palliative care unit. Methods: A nonblinded phase II randomized controlled trial of 80 patients who were randomly assigned to one of two groups: intervention group (dignity therapy + standard palliative care [SPC]) or control group (SPC alone). The main outcomes were depression and anxiety scores, as measured with the Hospital Anxiety and Depression Scale, and assessed at baseline (T1), day 4 (T2), day 15 (T3), and day 30 (T4) of follow-up. This study is registered with www.controlled-trials.com/ISRCTN34354086. Results: Of the final 80 participants, 41 were randomly assigned to SPC and 39 to dignity therapy. Baseline characteristics were similar between the two groups. Dignity therapy was associated with a decrease in depression scores (median, 95% confidence interval [CI]: - 4.00, - 6.00 to - 2.00, p < 0.0001; - 4.00, - 7.00 to - 1.00, p = 0.010; - 5.00, - 8.00 to - 1.00, p = 0.043, for T2, T3, and T4, respectively). Dignity therapy was similarly associated with a decrease in anxiety scores (median, 95% CI: - 3.00, - 5.00 to - 1.00, p < 0.0001; - 4.00, - 7.00 to - 2.00, p = 0.001; - 4.00, - 7.00 to - 1.00, p = 0.013, for T2, T3, and T4, respectively). Conclusion: Dignity therapy resulted in a beneficial effect on depression and anxiety symptoms in end-of-life care. The therapeutic benefit of dignity therapy was sustained over a 30-day period. Having established its efficacy, future trials of dignity therapy may now begin, comparing it with other psychotherapeutic approaches within the context of terminal illness.
