Training GroupPESCARNCT05220618
Efficacy of an Autobiographical Memory Specificity and Savoring Training for the Reduction of Depressive Symptomatology
A study testing Autobiographical Memory Specificity and Savoring Training: PESCAR in people with Training Group and Control Group, run by University of Valencia at 1 site in Spain.
Trial summary
The effect of autobiographical memory specificity and savoring training on memory specificity, positive affect regulation, well-being and depression symptomatology Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Training Group, Control Group
- What is being tested?
- Autobiographical Memory Specificity and Savoring Training: PESCAR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 12 Mar 2022to 16 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Preliminary Effects an Online Training to Increase the Specificity and Savoring of Positive Autobiographical Memories: a Randomized Controlled Pilot Study
The effect of autobiographical memory specificity and savoring training on memory specificity, positive affect regulation, well-being and depression symptomatology
Read the detailed description
The general objective of this study is to analyze the efficacy of an online-delivered Autobiographical Memory Specificity and SavoringTraining to increase the specificity of positive autobiographical memories, positive affect regulation strategies, well-being 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 regulation of autobiographical memories, and this will lead to a reduction of depressive symptomatology and increase of well-being.
- Conditions
- Training Group, Control Group
- Being tested
- Autobiographical Memory Specificity and Savoring Training: PESCAR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autobiographical Memory Specificity and Savoring Training: PESCARBehavioural
An autobiographical memory specificity and savoring 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) and savoring interventions (Bryant et al., 2005; Hanson et al., 2023). The training group will receive a self-guided intervention, which consists of an initial session (lasting 20 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 10-15 min approximately.
| Study group | Role | What they receive |
|---|---|---|
| PESCAR Training Group | Experimental | This group will receive an online two-week intervention to train the specificity and savoring of autobiographical memories. During the two-week intervention and the following two weeks, participants will complete continuous assessments (i.e. once a day) rate the their mood (positive and negative affect) as well as the level of positivity, specificity and savoring of positive memories recalled during practice session. For this study, we included continuous assessments 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). Receives: Behavioral: Autobiographical Memory Specificity and Savoring Training: PESCAR |
| Control Group | No intervention | This group will receive no intervention to train the specificity of autobiographical memories. During two weeks (from Day 0 to Day 15), participants will complete continuous assessments (i.e. once a day) to monitor their positive and negative affect. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autobiographical memory specificity. The Autobiographical Memory Test (AMT, Williams & Broadbent, 1986)
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.
Measured: Screening for eligibility criteria; Change in AMT from pre- intervention (Day 0) to post-intervention (Day 15)
Secondary outcomes (5)
Depressive symptomatology. The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001, Spanish adaptation Diez-Quevedo et al., 2001)
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).
Measured: 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)
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).
Measured: 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)
Characteristics of positive memories recalled. (Continuous assessments)
Continuous assessment involves repeated sampling of subjects' behaviours and experiences in real time and in their natural environments, minimizing recall bias, maximizing ecological validity and allowing 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 record on their smartphones pre- and post- practice session measures. Pre-practice, participants will rate their mood (i.e. level of positive and negative affect). Post-practice, participants will rate their mood, and characteristics of the memory (i.e. level of specificity and positivity) and the recalling process (i.e. level of savoring and quality of the memory recall). 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)
Measured: Daily mood and characteristics of positive memories 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)
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).
Measured: 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)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start12 Mar 2022
- Primary completion16 May 2024
- Study completion16 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Training GroupStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a pilot study with a mixed between-subject design (experimental condition that will receive the training, and control condition that will only receive the assessment) and within-subject (pre/post-training assessment and 2-week follow-up). Continuous assessments will also be used to longitudinally evaluate participants during the 14 days of training and the 14 days of follow-up.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosa M. Baños Rivera, University of Valencia
- Investigators
- Rosa Baños, Full Professor, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220618
- Sponsor's protocol ID
- 1612004
- Acronym
- PESCAR
- Status last verified
- Sep 2024
- First submitted
- 4 Jan 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 28013087Ros 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.
PubMed 29672583Barry 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.
PubMed 30776658Hitchcock 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.
PubMed 28086133Colombo, 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 at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Effects an Online Training to Increase the Specificity and Savoring of Positive Autobiographical Memories: a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT05220618
- Acronym / sponsor ID
- PESCAR / 1612004
- Conditions
- Training Group, Control Group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 12 Mar 2022 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of autobiographical memory specificity and savoring training on memory specificity, positive affect regulation, well-being and depression symptomatology
Detailed description
The general objective of this study is to analyze the efficacy of an online-delivered Autobiographical Memory Specificity and SavoringTraining to increase the specificity of positive autobiographical memories, positive affect regulation strategies, well-being 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 regulation of autobiographical memories, and this will lead to a reduction of depressive symptomatology and increase of well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a pilot study with a mixed between-subject design (experimental condition that will receive the training, and control condition that will only receive the assessment) and within-subject (pre/post-training assessment and 2-week follow-up). Continuous assessments will also be used to longitudinally evaluate participants during the 14 days of training and the 14 days of follow-up.
| Arm | Type | Receives |
|---|---|---|
| PESCAR Training Group | Experimental | Behavioral: Autobiographical Memory Specificity and Savoring Training: PESCARThis group will receive an online two-week intervention to train the specificity and savoring of autobiographical memories. During the two-week intervention and the following two weeks, participants will complete continuous assessments (i.e. once a day) rate the their mood (positive and negative affect) as well as the level of positivity, specificity and savoring of positive memories recalled during practice session. For this study, we included continuous assessments 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). |
| Control Group | No intervention | –This group will receive no intervention to train the specificity of autobiographical memories. During two weeks (from Day 0 to Day 15), participants will complete continuous assessments (i.e. once a day) to monitor their positive and negative affect. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autobiographical Memory Specificity and Savoring Training: PESCARAn autobiographical memory specificity and savoring 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) and savoring interventions (Bryant et al., 2005; Hanson et al., 2023). The training group will receive a self-guided intervention, which consists of an initial session (lasting 20 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 10-15 min approximately. | Behavioural | PESCAR Training Group |
Primary outcome
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.
5 secondary outcomes
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)
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)
Characteristics of positive memories recalled. (Continuous assessments)
Time frame: Daily mood and characteristics of positive memories 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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 28013087Takano 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.
- Background: PubMed 29672583Ros 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.
- Background: PubMed 30776658Barry 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.
- Background: PubMed 28086133Hitchcock 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.
- BackgroundColombo, 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Baños, Full Professor principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autobiographical Memory Specificity and Savoring Training: PESCAR in people with Training Group and Control Group, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05220618, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.