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Abstract:
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Complicated grief is a psychiatric disorder that affects many patients for long durations, with substantial impact on quality of life, functioning, and productivity. A psychotherapy, complicated grief treatment (CGT) has been shown to be efficacious in two previous randomized clinical trials. However there is an important need to assess efficacy for medication (citalopram; CIT), either as a stand-alone treatment, or in conjunction with CGT. Of primary interest is comparing: Aim 1. CIT vs. Placebo and Aim 2. CIT + CGT vs. Placebo + CGT. Of secondary interest is to assess benefits for CGT under naturalistic conditions, especially when administered with medication, that is, Aim 3. CIT + CGT vs. CIT + no CGT and Aim 4. CGT vs. no CGT. Finally, there is also interest in understanding the interaction between "CIT vs. Placebo" and "CGT vs. no CGT". In order to efficiently address these aims, a 2x2 factorial randomized trial was designed, implemented and completed. In this talk, we present the rationale for the design, how this impacted the analyses, and the specific approaches taken to account for missing data.
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