- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07589621
Safety Behavior Fading Versus Progressive Muscle Relaxation for Appearance Concerns
Safety Behavior Fading Versus Progressive Muscle Relaxation for Appearance Concerns: A Randomized Clinical Trial of Digital Interventions
The current study aims to explore the efficacy of a text message based safety behavior fading intervention compared to a progressive muscle relaxation intervention for appearance concerns.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Appearance-related safety behavior fading intervention procedures will follow methodology previously used in the Cougle Lab. The safety behavior fading intervention is designed to target a decrease or elimination of appearance-related safety behaviors. Individuals randomly assigned to the safety behavior fading condition will receive instructions to decrease or eliminate their endorsed appearance-related safety behaviors. In addition, they will receive daily reminders via text message to decrease these behaviors, along with a safety behavior monitoring checklist in which the participant indicates the extent to which they decreased and/or eliminated each safety behavior over the previous day. The daily reminder will include the following language: "Hi! This is a friendly reminder to avoid using your checklist behaviors. Please tap the link below to access today's checklist: [link to checklist]." Text messages will be delivered using EZtexting a text messaging platform used for research and marketing. Note that no identifying information will be included in this platform. Each participants phone number will be accompanied with a anonymized ID code. Individuals randomly assigned to the progressive muscle relaxation condition will be instructed to try and practice it daily for the 28 days. They will also receive daily text messages to remind them to practice relaxation and they can log which of the 10 different muscle groups they tensed and released in the past day.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Tallahassee, Florida, Estados Unidos, 32308
- Florida State University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- being between the ages of 18 and 65 years old
- having an internet-capable smart-phone
- scoring at or above the empirical cutoff for appearance concerns measured by the Social Appearance Anxiety Scale (i.e., 52)
Exclusion Criteria:
- changes in psychotropic medication in the last 4 weeks
- failing attention checks in baseline data collection
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Safety Behavior Fading
Individuals randomly assigned to the safety behavior fading condition will receive instructions to decrease or eliminate their endorsed appearance-related safety behaviors. In addition, they will receive daily reminders via text message to decrease these behaviors, along with a safety behavior monitoring checklist in which the participant indicates the extent to which they engaged in each safety behavior over the previous day. |
Participants are asked to reduce or eliminate safety behaviors via text message reminders and checklists to monitor progress.
Otros nombres:
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Comparador activo: Progressive Muscle Relaxation
Participants in this condition will be instructed to try and practice progressive muscle relaxation daily for 28 days. To match safety behavior fading they will also receive daily text messages to remind them to practice relaxation and they can log which of the 10 different muscle groups they tensed and released in the past day. |
Participants are asked to practice relaxation daily via text message reminder and checklists to monitor progress. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Social Appearance Anxiety Scale (SAAS)
Periodo de tiempo: Day 0, Day 28, Day 56
|
Self-report scale that measures appearance anxiety symptoms. Scores range from 16 to 80 with higher scores indicating higher levels of appearance concerns. |
Day 0, Day 28, Day 56
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Appearance Behaviors Checklist past-week version (author constructed)
Periodo de tiempo: Day 0, Day 28, Day 56
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Self-report scale used to measure frequency of engaging in appearance-related safety behaviors. This scale will be used as a manipulation check. Each item is rated on a 0 to 10 scale. Total scores range from 0 to 130 with higher scores indicating greater engagement in appearance-related safety behaviors |
Day 0, Day 28, Day 56
|
|
Appearance Anxiety Inventory (AAI; Veale et al., 2014)
Periodo de tiempo: Day 0, Day 28, Day 56
|
Self-report scale that measures of body dysmorphic symptoms. Scores range from 0 to 40 with higher scores indicating higher levels of body dysmorphic symptoms. |
Day 0, Day 28, Day 56
|
|
Social Phobia Inventory (SPIN; Connor et al., 2000)
Periodo de tiempo: Day 0, Day 28, Day 56
|
Self-report scale that measures social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety. |
Day 0, Day 28, Day 56
|
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Eating Disorder-15 (ED-15; Tatham et al., 2015).
Periodo de tiempo: Day 0, Day 28, Day 56
|
Self-report scale that measures eating disorder symptoms. Scores range from 0 to 90 with higher scores indicating higher levels of eating pathology. |
Day 0, Day 28, Day 56
|
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The Eating Disorder Inventory-Body Dissatisfaction (EDI; Garner et al., 1983).
Periodo de tiempo: Day 0, Day 28, Day 56
|
Self-report scale for measuring body dissatisfaction for use in clinical outcome studies. Each item is rated on a 0-5 scale with a total score range of 9-54 with higher scores indicating greater drive for thinness, bulimia, and body dissatisfaction. |
Day 0, Day 28, Day 56
|
|
Credibility and Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000).
Periodo de tiempo: Day 0
|
Self-report scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies. Three items are rated on a 0-10 scale and one item is rated on a 0-100 scale with higher scores meaning greater expectancy and credibility. |
Day 0
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Center for Epidemiologic Studies Depression Scale-10 (CESD; Andreson, 1994)
Periodo de tiempo: Day 0, Day 28, Day 56
|
Self-report measure of depression symptom severity. Each item is rated on a 0 to 3 scale. Total scores range from 0 to 30 with higher scores indicating greater depression severity. |
Day 0, Day 28, Day 56
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Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006)
Periodo de tiempo: Day 0, Day 28, Day 56
|
Self-report measure of anxiety symptom severity. Each item is rated on a 0 to 3 scale. Total scores range from 0 to 28 with higher scores indicating greater anxiety severity. |
Day 0, Day 28, Day 56
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Appearance Preference Task
Periodo de tiempo: Day 0, Day 28, Day 56
|
Computerized forced-choice task measuring appearance importance relative to other favorable characteristics. The APT randomly presents a series of 33 word pairs and asks the participant to select the concept that is more important to them. Each pair consists of a positive appearance-related adjective and a positive character trait unrelated to appearance (e.g., beautiful-responsible). Higher scores indicate greater endorsement of appearance words. |
Day 0, Day 28, Day 56
|
|
Social Interaction Scale (Author Constructed)
Periodo de tiempo: Day 0, Day 28, Day 56
|
Single-item self-report scale that the extent to which individuals engage with their social support networks. This question asks: "what percentage of your time awake did you spend interacting with others this past week (0% =No time at all, 100% =all of the time)?" |
Day 0, Day 28, Day 56
|
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Body Dysmorphic Disorder Symptom Scale-Cognitive Subscale (Wilhelm et al., 2016)
Periodo de tiempo: Day 0, Day 28, Day 56
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Self-report scale that measures cognitions related to body dysmorphic disorder. Scores range from 0 to 190 with higher scores indicating higher levels of maladaptive cognitions related to body dysmorphic disorder. |
Day 0, Day 28, Day 56
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Desordenes mentales
- Signos y Síntomas Digestivos
- Trastornos fóbicos
- Desórdenes de ansiedad
- Trastornos somatomorfos
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Fobia, Social
- Trastornos de la alimentación y la alimentación
- Trastornos dismórficos corporales
- Terapéutica
- Terapias de la mente-cuerpo
- Terapias complementarias
- Psicoterapia
- Disciplinas y actividades de comportamiento
- Hipnosis
- Entrenamiento autogénico
Otros números de identificación del estudio
- STUDY00007433
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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