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- Ensaio Clínico NCT05523453
Examinando os efeitos de um foco terapêutico em memórias positivas na saúde pós-trauma
Exame e refinamento de um novo tratamento para transtorno de estresse pós-traumático: técnica de processamento de memórias positivas (PPMT)
O transtorno de estresse pós-traumático (TEPT) tem consequências devastadoras para a saúde. As intervenções de TEPT baseadas em evidências abordam o fardo substancial do TEPT sobre a saúde de indivíduos e sociedades; no entanto, vários indivíduos que recebem essas intervenções desistem e nem todos experimentam melhora nos sintomas de TEPT. Além disso, essas intervenções atuais de TEPT visam principalmente memórias de traumas. Notavelmente, evidências crescentes sugerem que os sintomas de TEPT também estão relacionados a dificuldades na codificação e recuperação de memórias positivas.
Assim, o estudo proposto examinará os efeitos e os alvos subjacentes a uma nova técnica de TEPT focada em narrar e detalhar memórias positivas - Técnica de Processamento de Memórias Positivas (PPMT). Metodologicamente, 70 indivíduos serão designados aleatoriamente para PPMT vs. Aconselhamento de Apoio (SC) para este estudo.
Os objetivos do estudo proposto incluem (1) examinar os efeitos da PPMT na gravidade dos sintomas de TEPT e na desregulação dos sistemas de estresse (ou seja, despertar alfa amilase salivar [sAA] e cortisol); (2) examinar os mecanismos subjacentes aos efeitos do PPMT; e (3) refino de PPMT. A hipótese é que o braço PPMT relatará maiores reduções na gravidade do TEPT e nas taxas de sAA/cortisol. Além disso, existe a hipótese de que o afeto aprimorado relacionado à PPMT mediará a associação entre o braço do estudo (PPMT vs. SC) e as alterações na gravidade do TEPT. Por fim, será obtido feedback dos participantes do estudo sobre a viabilidade, formato e conteúdo do PPMT para refinar o PPMT.
O estudo proposto pode contribuir com evidências preliminares sobre a importância potencial de direcionar memórias positivas em intervenções de TEPT.
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Texas
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Denton, Texas, Estados Unidos, 76203
- University of North Texas
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Descrição
Critério de inclusão:
- 18-65 anos
- Disposto/capaz de fornecer consentimento informado
- Mês passado DSM-5 diagnóstico de transtorno de estresse pós-traumático (TEPT)
- Conhecimento prático de inglês
Critério de exclusão:
- Intenção ou tentativas suicidas ativas
- psicose ativa
- Atualmente recebendo terapia de saúde mental (últimos 3 meses)
- Mudanças de dosagem em medicamentos psiquiátricos (últimos 3 meses)
- Atualmente grávida
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Técnica de Processamento de Memórias Positivas (PPMT)
Os participantes recebem 5 sessões de 60 minutos da Técnica de Processamento de Memórias Positivas (PPMT) para PTSD seguindo os procedimentos de tratamento descritos no manual de terapia PPMT.
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O PPMT é composto por 5 sessões focadas na identificação e processamento de memórias positivas.
Nas Sessões 1-5, os participantes narram detalhes de uma memória positiva e processam a memória positiva para evocar valores, afetos, pontos fortes e pensamentos positivos.
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Comparador Ativo: Aconselhamento de Apoio (SC)
Os participantes recebem 5 sessões de aconselhamento de suporte (SC) de 60 minutos.
SC inclui uma discussão do diário de monitoramento diário e exploração de questões e preocupações atuais.
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SC é um tratamento ativo e inespecífico de 5 sessões administrado semanalmente, que inclui uma discussão do diário de monitoramento diário e exploração de questões e preocupações atuais.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Prazo: Baseline
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The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
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Baseline
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Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Prazo: Week 1 post-baseline during therapy session
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The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
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Week 1 post-baseline during therapy session
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Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Prazo: Week 2 post-baseline during therapy session
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The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
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Week 2 post-baseline during therapy session
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Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Prazo: Week 3 post-baseline during therapy session
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The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
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Week 3 post-baseline during therapy session
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Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Prazo: Week 4 post-baseline during therapy session
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The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
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Week 4 post-baseline during therapy session
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Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Prazo: Week 5 post-baseline during therapy session
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The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
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Week 5 post-baseline during therapy session
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Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Prazo: 1 week after the last therapy session, at week 6 post-baseline
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The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
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1 week after the last therapy session, at week 6 post-baseline
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Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Prazo: 3-months posttreatment completion, at week 18 post-baseline
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The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
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3-months posttreatment completion, at week 18 post-baseline
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Awakening Salivary Alpha Amylase to Cortisol Ratio
Prazo: 3 times each day for 2 consecutive days prior to first therapy session
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Via a passive drool procedure, participants provided 3 whole saliva samples each day for 2 consecutive days both prior to PPMT/SC: (1) immediately upon awakening, (2) 30 minutes post-awakening, and (3) 60 minutes post-awakening.
For each marker, for each day, area under the curve with respect to ground (AUCg) was calculated.
The two-day average AUCg of sAA was then divided by the two-day average AUCg of cortisol to create the ratio variable.
Higher sAA/cortisol ratio indicates greater stress system dysregulation and sympathetic nervous system dominance.
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3 times each day for 2 consecutive days prior to first therapy session
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Awakening Salivary Alpha Amylase to Cortisol Ratio
Prazo: 3 times each day for 2 consecutive days after the last therapy session
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Via a passive drool procedure, participants provided 3 whole saliva samples each day for 2 consecutive days one week following PPMT/SC: (1) immediately upon awakening, (2) 30 minutes post-awakening, and (3) 60 minutes post-awakening.
For each marker, for each day, area under the curve with respect to ground (AUCg) was calculated.
The two-day average AUCg of sAA was then divided by the two-day average AUCg of cortisol to create the ratio variable.
Higher sAA/cortisol ratio indicates greater stress system dysregulation and sympathetic nervous system dominance.
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3 times each day for 2 consecutive days after the last therapy session
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Positive and Negative Affect Schedule
Prazo: Baseline
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The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Baseline
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Positive and Negative Affect Schedule
Prazo: Week 1 post-baseline during therapy session
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The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Week 1 post-baseline during therapy session
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Positive and Negative Affect Schedule
Prazo: Week 2 post-baseline during therapy session
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The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Week 2 post-baseline during therapy session
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Positive and Negative Affect Schedule
Prazo: Week 3 post-baseline during therapy session
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The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Week 3 post-baseline during therapy session
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Positive and Negative Affect Schedule
Prazo: Week 4 post-baseline during therapy session
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The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Week 4 post-baseline during therapy session
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Positive and Negative Affect Schedule
Prazo: Week 5 post-baseline during therapy session
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The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Week 5 post-baseline during therapy session
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Positive and Negative Affect Schedule
Prazo: 1 week after the last therapy session, at week 6 post-baseline
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The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
1 week after the last therapy session, at week 6 post-baseline
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Positive and Negative Affect Schedule
Prazo: 3-months posttreatment completion, at week 18 post-baseline
|
The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
3-months posttreatment completion, at week 18 post-baseline
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ateka Contractor, PHD, University of North Texas Health Science Center
Publicações e links úteis
Publicações Gerais
- Contractor AA, Blumenthal H, Rosenfield D, Shea MT, Taylor DJ, Fentem A, Vingren JL. Study protocol and rationale for a pilot randomized clinical trial comparing processing of positive memories technique with supportive counseling for PTSD. Contemp Clin Trials. 2024 Mar;138:107455. doi: 10.1016/j.cct.2024.107455. Epub 2024 Jan 20.
- Rodenbaugh MM, Almeida I, Solakoglu L, Jin L, Contractor AA. Client and therapist experiences with the Processing of Positive Memories Technique (PPMT) in a randomized controlled trial: insights for protocol refinement. Eur J Psychotraumatol. 2026 Dec;17(1):2692887. doi: 10.1080/20008066.2026.2692887. Epub 2026 Jul 29.
- Contractor AA, Rosenfield D, Almeida IM, Wang S, Taylor DJ, Weiss NH, Shea MT. Comparison of the processing of positive memories technique and supportive counseling for posttraumatic stress disorder: A randomized controlled trial. Behav Res Ther. 2026 Aug;203:105087. doi: 10.1016/j.brat.2026.105087. Epub 2026 May 19.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- R15MH129773-01A1 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
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