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Efficacy of an Autobiographical Memory Specificity Training for the Reduction of Depressive Symptomatology (PESCAR)

1 de febrero de 2022 actualizado por: University of Valencia
The effect of Autobiographical Memory Specificity Training on memory specificity, positive affect and depression symptomatology

Descripción general del estudio

Descripción detallada

The general objective of this study is to analyze the efficacy of an online-delivered Autobiographical Memory Specificity Training to increase memory specificity, positive affect and to reduce depression symptomatology. It will be tested in two conditions (training group vs. control group) with low-to-moderate depressive symptomatology. It is hypothesized that the training group (over control group) will increase the specificity and positive affect of autobiographical memories, and this will lead to a reduction of depressive symptomatology.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

42

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: María Folgado, PhD candidate
  • Número de teléfono: 645722322
  • Correo electrónico: maria.folgado@uv.es

Copia de seguridad de contactos de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 55 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Age between 18 and 55 (following Serrano et al., 2007 recommendations)
  • Deficit in memory specificity: scores on Autobiographical Memory Test (AMT) < (or equal) 70%
  • Diagnosis of mild to moderate depression: scores on Patient Health Questionnaire (PHQ9) between 5 to 14

Exclusion Criteria:

  • being currently under psychological treatment
  • present any medical illness or physical, psychological and/or cognitive incapacity that could impede the participation
  • Not having the necessary technological means, i.e. access to a mobile phone with internet connection.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
Experimental: Memory Training Group
This group will receive an online two-week intervention to train the specificity of autobiographical memories. During the two-week intervention and the following two weeks, participants will complete ecological-momentary assessments (EMA) to monitor the amount of positive and specific memories recalled during the day. EMA is an Experience Sampling Method assessment system that allows data to be collected from participants in their natural environment at various points in time (McDevitt-Murphy et al., 2018). For this study, we designed an EMA to monitor essential project variables throughout the intervention (2 weeks; from Day 0 to Day 15) and then as a follow-up (2 weeks after; from Day 16 to Day 30).
An autobiographical memory specificity training has been developed by authors, based on previous training within the frame of Cognitive Bias Modification Interventions (CBM-I; Barry et al., 2019; Hitchcock et al., 2017). The training group will receive a self-guided intervention, which consists of an initial session (lasting 30 minutes approximately) and two-week training, conducted online. Participants will be provided with an online platform for following the intervention in a self-guided modality. The first session aims to give information about autobiographical memory functioning, to train in specificity recall through concrete processing steps and to explain the functioning of the self-guided modality. Then, during the next two weeks, participants will use the online platform once a day for practising the recall of autobiographical memories during 15-20 min approximately.
Sin intervención: Control Group
This group will receive no intervention to train the specificity of autobiographical memories. During four weeks (from Day 0 to Day 30), participants will complete ecological-momentary assessments (EMA) to monitor the amount of positive and specific memories recalled during the day.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Autobiographical memory specificity. The Autobiographical Memory Test (AMT, Williams & Broadbent, 1986)
Periodo de tiempo: Screening for eligibility criteria; Change in AMT from pre- intervention (Day 0) to post-intervention (Day 15)
AMT is the preferred measure to evaluate the degree of specificity of autobiographical memory. During the AMT application, nine verbal cue words of different valence (three positive, three negative and three neutral) will be presented to the participants to perform a recall task of specific personal memories (Dritschel et al., 2014). The specificity of the memories is scored by evaluators following specified criteria (Williams et al., 2007), and then, an overall estimate of the level of specificity of autobiographical memories can be calculated. The assessment will be conducted online, following previous works with the written version of the AMT (Takano et al., 2017). The spanish adaptation (Ros et al., 2018) has shown adequate psychometric properties in young and older populations.
Screening for eligibility criteria; Change in AMT from pre- intervention (Day 0) to post-intervention (Day 15)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Depressive symptomatology. The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001, Spanish adaptation Diez-Quevedo et al., 2001)
Periodo de tiempo: Change in PHQ-9 from pre- intervention (Day 0) to post-intervention (Day 15); Change in PHQ-9 from post- intervention (Day 15) to follow-up (Day 30)
PHQ-9 is a nine-item self-report measure of depressive symptoms. Participants answer the statements using a four-point Likert scale (0= Not at all to 3=Nearly every day) (Kroenke, Spitzer & Williams, 2001). The Spanish version has shown comparable diagnostic validity to the original English version, presenting levels of 88% of sensitivity and 88% of specificity (Diez-Quevedo et al., 2001).
Change in PHQ-9 from pre- intervention (Day 0) to post-intervention (Day 15); Change in PHQ-9 from post- intervention (Day 15) to follow-up (Day 30)
Savoring. Ways of Savoring Checklist (WOSC, Bryant & Veroff, 2007; Jose, Lim, & Bryant, 2012)
Periodo de tiempo: Change in WOSC from pre- intervention (Day 0) to post-intervention (Day 15); Change in WOSC from post- intervention (Day 15) to follow-up (Day 30)
An abbreviated 19-item os WOSC assess the use of thoughts and behaviours that facilitate savoring by amplifying positive feelings (11 items; for example, "I thought about sharing the memory of this later with other people") and the use of thoughts and behaviours that inhibit savoring by dampening positive emotions (eight items; for example, "I told myself why I didn't deserve this good thing"). Participants indicated to what extent statements described their thoughts and behaviours during positive experiences over the past week (1 = definitely doesn't apply, 7 = definitely applies). Previous studies have reported good psychometric properties with αs = .85-.86 (Smith and Hanni, 2019).
Change in WOSC from pre- intervention (Day 0) to post-intervention (Day 15); Change in WOSC from post- intervention (Day 15) to follow-up (Day 30)
Proportion of positive and negative memories recalled. (Ecological momentary assessment, EMA)
Periodo de tiempo: Average proportion of positive and negative memories recalled during intervention (From Day 1 to day 15).
EMA involves repeated sampling of subjects' behaviours and experiences in real time and in their natural environments. EMA procedure aims to minimise recall bias, maximise ecological validity and allow the study of micro-processes that influence behaviour. Previous studies have demonstrated the utility and validity of this assessment strategy in a variety of clinical and subclinical contexts (Colombo et al., 2020a, b).For this study, participants will receive a notification (only once a day) on their smartphones asking about the ratio of positive to negative memories they have recalled during the day. This measure will be taken once a day, everyday during intervention (14 days: From Day 1 to day 15) and at follow-up (14 days; from Day 16 to Day 30))
Average proportion of positive and negative memories recalled during intervention (From Day 1 to day 15).
Positive and negative affect. The Positive and Negative Affect Scale (PANAS; Watson et al., 1988; Sandín et al., 1999)
Periodo de tiempo: Screening for eligibility criteria; Change in PANAS from pre- intervention (Day 0) to post-intervention (Day 15); Change in PANAS from post- intervention (Day 15) to follow-up (Day 30)
A self-report measure consisting of two sub-scales that assess the person's positive and negative affect. Each scale is composed of 10 items, giving a total of 20 items on a 5-point Likert scale (1=not at all/very mild; 5=extreme). The PANAS is established as a scale to measure changes in mood with excellent psychometric properties in the general population in its Spanish version (Sandín et al., 1999). In addition, its reliability and validity has recently been evaluated in the assessment of people with emotional disorders. It has shown good to excellent internal consistency in both subscales (Cronbach's alpha for positive affect = 0.91; Cronbach's alpha for negative affect = 0.87).
Screening for eligibility criteria; Change in PANAS from pre- intervention (Day 0) to post-intervention (Day 15); Change in PANAS from post- intervention (Day 15) to follow-up (Day 30)
Well-being. Mental Health Continuum Scale (MHC: Keyes, 2004; Echevarría et al., 2010)
Periodo de tiempo: Screening for eligibility criteria; Change in MHC from pre- intervention (Day 0) to post-intervention (Day 15); Change in MHC from post- intervention (Day 15) to follow-up (Day 30)
MHC-LF is a multidimensional measure, composed of 14 items measuring emotional (3 items), social (5 items) and psychological (6 items) well-being. It assesses the frequency with which they felt a certain way during the last month. Psychometric analyses of the Spanish validation (Echevarría et al., 2010) showed that it was a scale with good psychometric properties.
Screening for eligibility criteria; Change in MHC from pre- intervention (Day 0) to post-intervention (Day 15); Change in MHC from post- intervention (Day 15) to follow-up (Day 30)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Rosa Baños, Full Professor, University of Valencia

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Anticipado)

12 de marzo de 2022

Finalización primaria (Anticipado)

7 de marzo de 2023

Finalización del estudio (Anticipado)

12 de marzo de 2023

Fechas de registro del estudio

Enviado por primera vez

4 de enero de 2022

Primero enviado que cumplió con los criterios de control de calidad

1 de febrero de 2022

Publicado por primera vez (Actual)

2 de febrero de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de febrero de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

1 de febrero de 2022

Última verificación

1 de noviembre de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 1612004

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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