Psychoeducation Group for Depression (PEG-D): Study protocol for a prospective, randomized, single-blind, crossover trial.

BACKGROUND

Considered a leading contributor to the global health burden, depression is characterized by its multifaceted nature. Recognizing the limitations of pharmacological treatments, non-pharmacological alternatives have been suggested to enhance full remission and increase quality of life.

AIM

To contribute to this field, we aim to develop and investigate the efficacy of a short psychoeducational program as an adjunctive treatment for depression.

METHODS/DESIGN: We propose a single-center, prospective, crossover, single blind, randomized controlled trial, with 190 patients diagnosed with Major Depressive Disorder-MDD (DSM-5-TR), and moderate or intense severity by Hamilton Depression Rating Scale -HAMD-17. Participants will be randomly assigned to one of two arms, Treatment as usual (TAU) + Psychoeducation (n = 96) or TAU (n = 96). The psychoeducational program will consist of six weekly group sessions (6-10 participants) with each session lasting 90 minutes, covering information and techniques for identifying and coping with depression. Reduction in depressive levels, measured by the Beck Depression Inventory-BDI-II, and an increase in their level of knowledge on depression will be considered our primary outcome. Secondary outcomes, such as improvement in functionality and quality of life, will be measured by the Global Functioning Rating Scale (GAF), Clinical Global Impression Scale, and cognitive and behavioral factors by the Cognitive and Behavioral Avoidance Scale-CBAS, and Thoughts Scale Depressants-DTS (EPD).

DISCUSSION

Developing and validating a structured psychoeducational program for depression is crucial for understanding the contribution of psychoeducation for depression and to facilitate the replication of findings, if positive. If our program demonstrates efficacy-superiority compared to TAU treatment, it might present as an interesting, cost-effective alternative as an adjunctive treatment. An expansion to other modalities, including open groups, euthymic patients, and online formats, might be considered, depending on our results.

TRIAL REGISTRATION

NCT06467474.