- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05220618
Efficacy of an Autobiographical Memory Specificity Training for the Reduction of Depressive Symptomatology (PESCAR)
February 1, 2022 updated by: University of Valencia
The effect of Autobiographical Memory Specificity Training on memory specificity, positive affect and depression symptomatology
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: María Folgado, PhD candidate
- Phone Number: 645722322
- Email: maria.folgado@uv.es
Study Contact Backup
- Name: Marta Miragall, PhD
- Email: marta.miragall@uv.es
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Autobiographical memory specificity. The Autobiographical Memory Test (AMT, Williams & Broadbent, 1986)
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depressive symptomatology. The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001, Spanish adaptation Diez-Quevedo et al., 2001)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rosa Baños, Full Professor, University of Valencia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 12, 2022
Primary Completion (Anticipated)
March 7, 2023
Study Completion (Anticipated)
March 12, 2023
Study Registration Dates
First Submitted
January 4, 2022
First Submitted That Met QC Criteria
February 1, 2022
First Posted (Actual)
February 2, 2022
Study Record Updates
Last Update Posted (Actual)
February 2, 2022
Last Update Submitted That Met QC Criteria
February 1, 2022
Last Verified
November 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 1612004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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