Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

1. februar 2022 opdateret af: University of Valencia
The effect of Autobiographical Memory Specificity Training on memory specificity, positive affect and depression symptomatology

Studieoversigt

Status

Ikke rekrutterer endnu

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

42

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 55 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Autobiographical memory specificity. The Autobiographical Memory Test (AMT, Williams & Broadbent, 1986)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Depressive symptomatology. The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001, Spanish adaptation Diez-Quevedo et al., 2001)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Rosa Baños, Full Professor, University of Valencia

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

12. marts 2022

Primær færdiggørelse (Forventet)

7. marts 2023

Studieafslutning (Forventet)

12. marts 2023

Datoer for studieregistrering

Først indsendt

4. januar 2022

Først indsendt, der opfyldte QC-kriterier

1. februar 2022

Først opslået (Faktiske)

2. februar 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. februar 2022

Sidst verificeret

1. november 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 1612004

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kontrolgruppe

Kliniske forsøg med Autobiographical Memory Specificity Training PESCAR

3
Abonner