- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05220618
Efficacy of an Autobiographical Memory Specificity Training for the Reduction of Depressive Symptomatology (PESCAR)
2022년 2월 1일 업데이트: University of Valencia
The effect of Autobiographical Memory Specificity Training on memory specificity, positive affect and depression symptomatology
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (예상)
42
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: María Folgado, PhD candidate
- 전화번호: 645722322
- 이메일: maria.folgado@uv.es
연구 연락처 백업
- 이름: Marta Miragall, PhD
- 이메일: marta.miragall@uv.es
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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간섭 없음: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Autobiographical memory specificity. The Autobiographical Memory Test (AMT, Williams & Broadbent, 1986)
기간: Screening for eligibility criteria; Change in AMT from pre- intervention (Day 0) to post-intervention (Day 15)
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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.
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Screening for eligibility criteria; Change in AMT from pre- intervention (Day 0) to post-intervention (Day 15)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Depressive symptomatology. The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001, Spanish adaptation Diez-Quevedo et al., 2001)
기간: 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)
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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).
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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)
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Savoring. Ways of Savoring Checklist (WOSC, Bryant & Veroff, 2007; Jose, Lim, & Bryant, 2012)
기간: 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)
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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).
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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)
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Proportion of positive and negative memories recalled. (Ecological momentary assessment, EMA)
기간: Average proportion of positive and negative memories recalled during intervention (From Day 1 to day 15).
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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))
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Average proportion of positive and negative memories recalled during intervention (From Day 1 to day 15).
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Positive and negative affect. The Positive and Negative Affect Scale (PANAS; Watson et al., 1988; Sandín et al., 1999)
기간: 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)
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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).
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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)
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Well-being. Mental Health Continuum Scale (MHC: Keyes, 2004; Echevarría et al., 2010)
기간: 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)
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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.
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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)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Rosa Baños, Full Professor, University of Valencia
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Takano K, Mori M, Nishiguchi Y, Moriya J, Raes F. Psychometric properties of the written version of the autobiographical memory test in a japanese community sample. Psychiatry Res. 2017 Feb;248:56-63. doi: 10.1016/j.psychres.2016.12.019. Epub 2016 Dec 16.
- Ros L, Romero D, Ricarte JJ, Serrano JP, Nieto M, Latorre JM. Measurement of overgeneral autobiographical memory: Psychometric properties of the autobiographical memory test in young and older populations. PLoS One. 2018 Apr 19;13(4):e0196073. doi: 10.1371/journal.pone.0196073. eCollection 2018.
- Barry TJ, Sze WY, Raes F. A meta-analysis and systematic review of Memory Specificity Training (MeST) in the treatment of emotional disorders. Behav Res Ther. 2019 May;116:36-51. doi: 10.1016/j.brat.2019.02.001. Epub 2019 Feb 2.
- Hitchcock C, Werner-Seidler A, Blackwell SE, Dalgleish T. Autobiographical episodic memory-based training for the treatment of mood, anxiety and stress-related disorders: A systematic review and meta-analysis. Clin Psychol Rev. 2017 Mar;52:92-107. doi: 10.1016/j.cpr.2016.12.003. Epub 2016 Dec 21.
- Colombo, D., Suso-Ribera, C., Fernández-Álvarez, J., Cipresso, P., Garcia-Palacios, A., Riva, G., & Botella, C. (2020). Affect Recall Bias: Being Resilient by Distorting Reality. Cognitive Therapy and Research, 44(5), 906-918. https://doi.org/10.1007/s10608-020-10122-3
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (예상)
2022년 3월 12일
기본 완료 (예상)
2023년 3월 7일
연구 완료 (예상)
2023년 3월 12일
연구 등록 날짜
최초 제출
2022년 1월 4일
QC 기준을 충족하는 최초 제출
2022년 2월 1일
처음 게시됨 (실제)
2022년 2월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 2월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 2월 1일
마지막으로 확인됨
2021년 11월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 1612004
약물 및 장치 정보, 연구 문서
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아니
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아니
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