Effects of a Contextual Adaptation of the Unified Protocol in Multiple Emotional Disorders in Individuals Exposed to Armed Conflict in Colombia

Abstract

ImportanceA transdiagnostic treatment, the Unified Protocol, is as effective as single diagnostic protocols in comorbid emotional disorders in clinical populations. However, its effects on posttraumatic stress disorder and other emotional disorders in individuals living in war and armed conflict contexts have not been studied.ObjectiveTo evaluate the efficacy of a cultural and contextual adaptation of the Unified Protocol (CXA-UP) on posttraumatic stress disorder, anxiety, and depression compared to waitlist control in individuals exposed to armed conflict in Colombia.Design, Setting, and ParticipantsFrom April 2017 to March 2020, 200 participants 18 years and older were randomly assigned to the CXA-UP or to a waitlist condition. CXA-UP consisted of 12 to 14 twice-a-week or weekly individual 90-minute face-to-face sessions. Outcomes were assessed at baseline, posttreatment, and 3 months following treatment. Analyses were performed and compared for all randomly allocated participants (intent-to-treat [ITT]) and for participants who completed all sessions and posttreatment measures (per protocol [PP]). The study took place at an outpatient university center and included individuals who were registered in the Colombian Victims Unit meeting DSM-5 diagnostic criteria for posttraumatic stress disorder, anxiety, or depression or were severely impaired by anxiety or depression. Individuals who were receiving psychological therapy, were dependent on alcohol or drugs, were actively suicidal or had attempted suicide in the previous 2 months, had psychosis or bipolar disorder, or were cognitively impaired were excluded.InterventionCXA-UP or waitlist.Main Outcomes and MeasuresPrimary outcomes were changes in anxiety, depression, and somatic scores on the Patient Health Questionnaire and Posttraumatic Stress Disorder Checklist for DSM-5.ResultsAmong the 200 participants (160 women [80.0%]; 40 men [20.0%]; mean [SD] age, 43.1 [11.9] years), 120 were randomized to treatment and 80 to waitlist. Results for primary outcomes in the ITT analysis showed a significant pretreatment-to-posttreatment reduction when comparing treatment and waitlist on the posttraumatic stress disorder checklist for DSM-5 scores (slope [SE], −31.12 [3.00]; P < .001; Cohen d, 0.90; 90% CI, 0.63-1.19), 9-item Patient Health Questionnaire (PHQ-9) (slope [SE],−11.94 [1.30]; P < .001; Cohen d, 0.77; 90% CI, 0.52-1.06), PHQ-anxiety (slope [SE], −6.52 [0.67]; P < .001; Cohen d, 0.82; 90% CI, 0.49-1.15), and PHQ-somatic (slope [SE], −8.31 [0.92]; P < .001; Cohen d, 0.75; 90% CI, 0.47-1.04).Conclusions and RelevanceIn this study, significant reductions and large effect sizes in all measures of different emotional disorders showed efficacy of a single transdiagnostic intervention in individuals exposed to armed conflicts.Trial RegistrationClinicalTrials.gov Identifier: NCT03127982

The promise of transdiagnostic treatment in rural primary care: The unified protocol.

“…Specifically, the UP was efficacious when translated and culturally adapted in the contexts of a randomized controlled trial for individuals from remote areas of Colombia who were exposed to violence (e.g., armed conflict) and met criteria for posttraumatic stress disorder (PTSD), anxiety, and/or depression. In contrast to previous studies with single-disorder protocols in lower income countries that yielded moderate effects without maintenance of treatment results at follow-up, this study by Castro-Camacho et al (2023) revealed significant reductions with large effect sizes in PTSD, PTSD checklist for Diagnostic and Statistical Manual of Mental Disorders, fifth edition scores: slope ( SE ), −31.12 [3.00]; p < .001; Cohen d , 0.90, depression, nine-item Patient Health Questionnaire: slope ( SE ), −11.94 [1.30]; p < .001; Cohen d , 0.77, and anxiety, Patient Health Questionnaire—anxiety: slope ( SE ), −6.52 [0.67]; p < .001; Cohen d , 0.82. Furthermore, the UP demonstrated feasibility when modified in a randomized controlled trial within an inpatient setting consisting of patients with suicidal thoughts and behaviors, in addition to low educational attainment, unemployment and homelessness (Bentley et al, 2017).…”

Multidimensional Emotional Disorder Inventory: reliability and validity in a Colombian non-clinical sample

“…This differentiation may not only manifest in divergent mean scores across MEDI dimensions but also in the elicitation of processes and symptoms specific to trauma-related disorders—a characteristic seldom encountered within a non-clinical population (Contractor et al, 2020 ). A study in Colombia examining the effects of a culturally adapted Unified Protocol on a heterogeneous clinical sample of emotional disorders demonstrated that indeed, the clinical population exhibits high scores on tests measuring symptoms associated with PTSD, particularly the PCL-5 (Castro-Camacho et al, 2023 ). Moreover, a case study also reported in this same study indicated that in vulnerable clinical populations (from low-income backgrounds), the presence of trauma is common due to typical conditions of insecurity and a history of internal armed conflict in Colombia (Castro-Camacho et al, 2018 ).…”

“…Further research into the validation of the MEDI in both clinical and non-clinical populations is warranted. Recently, in Colombia, there has been a growing interest in researching the efficacy (Castro-Camacho et al, 2023 ), effectiveness (Castro-Camacho et al, 2018 , 2019 ), prevention (Castro-Camacho et al, 2022 ), and dissemination of transdiagnostic treatments (Zarate‐Guerrero et al, 2022 ). Given the transdiagnostic structure of the MEDI, having a validated version for the Colombian population would be immensely beneficial.…”

Abordajes transdiagnósticos en los trastornos emocionales a nivel iberoamericano: una revisión crítica

“…Para obtener detalles exhaustivos sobre las adaptaciones realizadas, se recomienda consultar el trabajo de Castro-Camacho et al (2019). Recientemente un ensayo controlado aleatorizado de la versión adaptada del PU mostró disminuciones significativas con grandes tamaños del efecto en medidas de trastorno por estrés postraumático, ansiedad, depresión y quejas somáticas que se mantuvieron a los tres meses de seguimiento (Castro-Camacho et al, 2023).…”