Ensaio clínico randomizado controlado comparativo com mulheres com diagnóstico de Transtorno de Estresse Pós-traumático após abuso sexual entre terapia interpessoal e sertralina
Data
2024-08-09
Autores
Proença, Cecília Roberti 
Orientadores
Mello, Andrea Feijó de
Tipo
Tese de doutorado
Título da Revista
ISSN da Revista
Título de Volume
Resumo
Introdução: A violência sexual é um dos eventos traumáticos que mais frequentemente desencadeia o transtorno de estresse pós-traumático (TEPT), condição clínica que pode se tornar crônica e debilitante se não for tratada precocemente e de forma efetiva. Embora a maioria das diretrizes recomende inibidores seletivos de recaptação de serotonina e psicoterapias focadas no trauma como opções de tratamento, nem todos os pacientes respondem a essas abordagens, além de muitos não tolerarem a exposição às memórias traumáticas. Já existem estudos na literatura que evidenciam a eficácia de terapias não focadas no trauma, como a terapia interpessoal (TIP), que explora as consequências interpessoais do trauma, em vez de confrontar o trauma em si.
Objetivo: O presente estudo visa comparar a eficácia da terapia interpessoal adaptada para o TEPT (TIP-TEPT) com a sertralina em mulheres que sofreram violência sexual recente, por meio de um ensaio clínico. Visa também explorar as trajetórias de resposta terapêutica em busca de fatores preditores, principalmente o abuso sexual infantil.
Método: Este estudo consistiu em um ensaio clínico randomizado e controlado com duração de 14 semanas, envolvendo mulheres diagnosticadas com TEPT decorrente de violência sexual sofrida até seis meses antes da inclusão. As participantes foram randomizadas para receber um dos dois tratamentos, sertralina ou TIP-TEPT. Após o período de intervenção, as participantes foram acompanhadas até completar um ano da inclusão. Foram aplicados instrumentos de avaliação para mensurar os sintomas de TEPT, ansiedade e depressão. A Escala de TEPT Administrada por Clínicos-5 (CAPS-5) foi a principal medida de desfecho. Além disso, a análise de trajetória de classe latente foi utilizada para avaliar preditores de resposta ao tratamento ao final do ensaio clínico e após um ano de acompanhamento.
Resultados: Foram incluídas 74 mulheres, 35 no braço sertralina e 39 no braço TIP. Ambos os tratamentos reduziram significativamente os sintomas de TEPT, ansiedade e depressão, sem diferenças nos resultados entre os grupos. A média da CAPS-5 diminuiu de 42,5 (DP = 9,4) para 27,1 (DP = 15,9) com a sertralina e de 42,6 (DP = 9,1) para 29,1 (DP = 15,5) com a TIP-TEPT. A taxa de abandono do ensaio clínico foi alta, 37,8%, sem diferença significativa entre os grupos (p = 0,40). O modelo não condicional de duas classes, resposta e não resposta, foi o modelo que melhor explicou as trajetórias das pacientes ao longo do estudo. O abuso sexual na infância foi avaliado como fator preditor, sendo associado negativamente à resposta terapêutica.
Conclusões: Este ensaio mostrou melhora significativa dos sintomas de TEPT, independente da variável tempo, em ambos os braços do estudo, sem diferenças entre a TIP-TEPT e o tratamento com sertralina, sugerindo que psicoterapias não baseadas em exposição podem beneficiar pacientes com TEPT. A identificação do abuso sexual na infância como fator preditor de resposta terapêutica, independente da abordagem terapêutica, é um alerta para os clínicos avaliarem os pacientes de forma individualizada, personalizando o tratamento a ser oferecido.
Introduction: Sexual violence is one of the traumatic events most commonly associated with post-traumatic stress disorder (PTSD), a clinical condition that can become chronic and debilitating if not treated early and effectively. While most guidelines recommend selective serotonin reuptake inhibitors and trauma-focused psychotherapies as treatment options, not all patients respond to these approaches, and many do not tolerate being exposed to traumatic memories. Literature suggests the effectiveness of non-trauma-focused therapies, such as Interpersonal Psychotherapy (IPT), which focuses on interpersonal consequences rather than trauma itself. Objective: This study aims to compare the efficacy of Interpersonal Psychotherapy Adapted for PTSD (IPT-PTSD) with sertraline in women who have experienced recent sexual violence, in a randomized clinical trial, exploring therapeutic response trajectories and investigating the role of childhood sexual abuse as a response predictor. Method: This study consisted of a 14-week randomized and controlled clinical trial involving women diagnosed with PTSD resulting from sexual violence, experienced up to six months before inclusion. Participants were randomized assigned to receive either sertraline or IPT-PTSD. Following the intervention period, participants were monitored until one year after inclusion. PTSD, anxiety, and depressive symptoms were evaluated with assessment tools. The Clinician-Administered PTSD Scale-5 (CAPS-5) served as the primary outcome measure. Additionally, latent class trajectory analysis was used to assess predictors of treatment response at the end of the clinical trial and after one year of follow-up. Results: 74 women were included, with 39 allocated to IPT-PTSD and 35 to sertraline group. Both treatments significantly reduced PTSD, anxiety, and depression symptoms, with no differences between groups. CAPS-5 mean scores decreased from 42.5 (SD = 9.4) to 27.1 (SD = 15.9) with sertraline and from 42.6 (SD = 9.1) to 29.1 (SD = 15.5) with IPT-PTSD. Attrition rate in the clinical trial was high, 37,8%, without significant difference between groups (p = 0.40). The unconditional two-class model, “response and non-response”, best explained patient trajectories throughout the study. Childhood sexual abuse was identified as a predictor, negatively associated with therapeutic response. Conclusions: This trial found significant improvement in PTSD symptoms, regardless of time, in both study arms, with no differences between IPT-PTSD and sertraline treatment, suggesting that non-exposure-based psychotherapies may benefit PTSD patients. Identifying childhood sexual abuse as a predictor of therapeutic response, regardless of the therapeutic approach, alert clinicians to assess patients individually, personalizing treatment options.
Introduction: Sexual violence is one of the traumatic events most commonly associated with post-traumatic stress disorder (PTSD), a clinical condition that can become chronic and debilitating if not treated early and effectively. While most guidelines recommend selective serotonin reuptake inhibitors and trauma-focused psychotherapies as treatment options, not all patients respond to these approaches, and many do not tolerate being exposed to traumatic memories. Literature suggests the effectiveness of non-trauma-focused therapies, such as Interpersonal Psychotherapy (IPT), which focuses on interpersonal consequences rather than trauma itself. Objective: This study aims to compare the efficacy of Interpersonal Psychotherapy Adapted for PTSD (IPT-PTSD) with sertraline in women who have experienced recent sexual violence, in a randomized clinical trial, exploring therapeutic response trajectories and investigating the role of childhood sexual abuse as a response predictor. Method: This study consisted of a 14-week randomized and controlled clinical trial involving women diagnosed with PTSD resulting from sexual violence, experienced up to six months before inclusion. Participants were randomized assigned to receive either sertraline or IPT-PTSD. Following the intervention period, participants were monitored until one year after inclusion. PTSD, anxiety, and depressive symptoms were evaluated with assessment tools. The Clinician-Administered PTSD Scale-5 (CAPS-5) served as the primary outcome measure. Additionally, latent class trajectory analysis was used to assess predictors of treatment response at the end of the clinical trial and after one year of follow-up. Results: 74 women were included, with 39 allocated to IPT-PTSD and 35 to sertraline group. Both treatments significantly reduced PTSD, anxiety, and depression symptoms, with no differences between groups. CAPS-5 mean scores decreased from 42.5 (SD = 9.4) to 27.1 (SD = 15.9) with sertraline and from 42.6 (SD = 9.1) to 29.1 (SD = 15.5) with IPT-PTSD. Attrition rate in the clinical trial was high, 37,8%, without significant difference between groups (p = 0.40). The unconditional two-class model, “response and non-response”, best explained patient trajectories throughout the study. Childhood sexual abuse was identified as a predictor, negatively associated with therapeutic response. Conclusions: This trial found significant improvement in PTSD symptoms, regardless of time, in both study arms, with no differences between IPT-PTSD and sertraline treatment, suggesting that non-exposure-based psychotherapies may benefit PTSD patients. Identifying childhood sexual abuse as a predictor of therapeutic response, regardless of the therapeutic approach, alert clinicians to assess patients individually, personalizing treatment options.
Descrição
Citação
PROENÇA, Cecília Roberti. Ensaio clínico randomizado controlado comparativo com mulheres com diagnóstico de Transtorno de Estresse Pós-traumático após abuso sexual entre terapia interpessoal e sertralina. 2024. 132 f. Tese (Doutorado em Psiquiatria e Psicologia Médica) – Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, 2024.