Cognitive-behavioral Therapy vs. Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder Part II (COUNTERACT-2)
Cognitive and Neural Mechanisms of Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder Part II: Mediation Effects
This study is a randomized controlled trial assessing the efficacy of cognitive- behavioral therapy (CBT-AR) and nutrition counseling for avoidant/restrictive food intake disorder (ARFID) for children and adolescents (ages 10-18 years).
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Jennifer J. Thomas, PhD
- Número de telefone: 617-643-6306
- E-mail: jjthomas@mgh.harvard.edu
Locais de estudo
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Recrutamento
- Eating Disorders Clinical and Research Program
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Contato:
- Stefania Yee
- Número de telefone: 617-724-0799
- E-mail: syee5@mgh.harvard.edu
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Males and Females ages 10-18 years old
- Current ARFID assessed via Feeding and Eating Disorders Model from the "Enhanced" Structured Interview for DSM-5 (SCID-5)
- Normal TSH or free T4 levels to rule out thyroid disease as cause of symptoms inclusionary for randomization
- Negative celiac screening panel indicating no active celiac disease as cause of symptoms inclusionary for randomization
- Fluency and literacy in English
Exclusion Criteria:
- Patient requires weight restoration treatment (e.g., < 5th percentile of BMI, height, or weight for sex and age; patient has fallen off individual growth trajectory; patient's medical providers have recommended weight restoration) such that 15 sessions of CBT-AR is not appropriate
- Pregnancy, breastfeeding, or recent initiation/cessation of estrogen-containing systemic contraceptives within 8 weeks of the pre-treatment study visit (as these could impact neuroimaging)
- Current/history of psychosis via Mini-International Neuropsychiatric Interview child/adolescent version (MINI KID)
- Substance/alcohol use disorder (active within the past month) via MINI KID
- Medical instability requiring inpatient care according to the American Psychiatric Association 2006 treatment guidelines for eating disorders
- Laboratory abnormalities indicating a need for higher level of care (assessed by complete blood count and comprehensive metabolic panel) exclusionary for randomization
- Complete lack of oral intake (suggesting a need for inpatient care)
- Tube feeding (suggesting a need for tube weaning) Significant weight/shape concern-motivating eating pathology as evidenced by a global Eating Disorders Examination Questionnaire (EDE-Q) score greater than 4
- Active suicidal ideation with intent or plan via the 5-item Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)
- Contraindications to MRI
- History of major gastrointestinal tract surgery or serious medical condition (e.g., cancer)
- Medical history of intellectual disability
- Illiteracy
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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Experimental: CBT-AR
See intervention description |
Comportamental: Cognitive-Behavioral Therapy for Avoidance Restrictive Food Intake Disorder (CBT-AR)
CBT-AR is a four-stage modular treatment for ARFID delivered by a mental health clinician. The four stages include: 1) Psychoeducation and early change; 2) Treatment planning; 3) Addressing maintaining mechanisms; and 4) Relapse prevention. For participants ages 10-15 years, patients/guardians attend the sessions. For patients ages 16 and up, the therapy is individual. |
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Experimental: Nutrition Counseling
See intervention description |
Nutrition counseling will be provided by skilled registered dietitians at the MGH Translational and Clinical Research Center (TCRC). Sessions focus on the foods necessary for a healthy diet, how to meet nutritional needs, how to incorporate healthy exercise, and support for making these changes. For participants ages 10-15 years, patients/guardians attend the sessions. For patients ages 16 and up, the therapy is individual. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pica, ARFID, and Rumination Disorder Interview
Prazo: Change from baseline measured at Pre-Treatment to Mid-Treatment to 15 weeks of treatment measured at Post-Treatment.
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A semi-structured clinical interview assessing the symptoms and severity of Pica, ARFID, and Rumination Disorder. This interview is used to determine the presence and severity of each ARFID profile. Scores for each severity measure are assessed on a scale from 0 to 6, with higher scores indicating greater severity. |
Change from baseline measured at Pre-Treatment to Mid-Treatment to 15 weeks of treatment measured at Post-Treatment.
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Pica, ARFID, and Rumination Disorder ARFID Questionnaire
Prazo: Change from baseline measured at Pre-Treatment to Mid-Treatment to 15 weeks of treatment measured at Post-Treatment.
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A 32-item revised version of the Pica, ARFID, and Rumination Disorder Interview used to assess ARFID severity and presence of Pica or Rumination Disorder. Each item is assessed on a scale from 0 to 6, with higher scores indicating greater severity. |
Change from baseline measured at Pre-Treatment to Mid-Treatment to 15 weeks of treatment measured at Post-Treatment.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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General Nutrition Knowledge Questionnaire
Prazo: Completed at Pre-Treatment Assessment (Baseline/Week 0), Mid-Treatment Assessment (Week 8 +/- 2 sessions), and Post-Treatment Assessment (Week 16 up to Week 19)
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A revised version of the General Nutrition Knowledge Questionnaire (GNKQ) used to evaluate knowledge of nutrition. Scores are gathered through a series of multiple-choice questions. The lowest score possible is 0, indicating low knowledge of nutrition, and the highest score possible is 14, indicating high knowledge of nutrition. |
Completed at Pre-Treatment Assessment (Baseline/Week 0), Mid-Treatment Assessment (Week 8 +/- 2 sessions), and Post-Treatment Assessment (Week 16 up to Week 19)
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4-Day Food Record
Prazo: Completed at Pre-Treatment Assessment (Baseline/Week 0), Mid-Treatment Assessment (Week 8 +/- 2 sessions), and Post-Treatment Assessment (Week 16 up to Week 19)
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A record of participant diet for four days prior to the Pre-Treatment Assessment and for another four days prior to the Post-Treatment Assessment. Dietary information is calculated from the recorded foods. |
Completed at Pre-Treatment Assessment (Baseline/Week 0), Mid-Treatment Assessment (Week 8 +/- 2 sessions), and Post-Treatment Assessment (Week 16 up to Week 19)
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
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Última atualização enviada que atendeu aos critérios de controle de qualidade
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Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026P002222
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
The investigators will upload de-identified data to the NIMH National Data Archive at the conclusion of the study
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