Implementation of memory specificity training (MeST) in routine clinical practices in Belgium using a web-based self-directed training protocol
| ISRCTN | ISRCTN16178120 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16178120 |
| Secondary identifying numbers | G 2014 12 113 (extension) |
- Submission date
- 09/06/2019
- Registration date
- 11/06/2019
- Last edited
- 29/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Accumulating evidence shows that a cognitive factor associated with a worsening of depressive symptoms amongst people with and without diagnoses of depression – reduced Autobiographical Memory (rAMS) – can be ameliorated by a group cognitive training protocol referred to as Memory Specificity Training (MeST). After assessing transportability (https://bmcpsychology.biomedcentral.com/articles/10.1186/s40359-019-0279-y) the subsequent study aims to assess implementation of MeST using a self-directed web-based training protocol.
Who can participate?
Adult people who are currently being treated in the participating Routine Clinical Practices, and who show reduced autobiographical memory specificity as assessed by the Autobiographical Memory Test. All clinical practices in Belgium were welcome to participate.
What does the study involve?
The study involves the group training Memory Specificity Training. In this training, people train in getting better at retrieving personal memories and retrieving more details.
What are the possible benefits and risks of participating?
Participating in this study might impact the cognitive vulnerabiltiy factor, which can have a concomitant effect on depressive symptoms and related processes as rumination. No side effects or risks are known. Retrieving unpleasant autobiographical memories and noticing that people lack this skill might be experienced as inconvenient.
Where is the study run from?
This study is run from the KU Leuven. Routine Clinical Settings in Flanders can participate after which local clinicians are trained using the online training protocol so that MeST can be offered to patients as a part of the standard routine care, after adapting MeST.
When is the study starting and how long is it expected to run for?
The study runs from 1/4/2016 to 30/12/2018.
Who is funding the study?
The study is funded by the KU Leuven Program Funding Grant PF/10/005.
Who is the main contact?
Kris Martens
kris.martens@kuleuven.be
Contact information
Public
Tiensestraat 102 - box 3712
Leuven
3000
Belgium
 ORCID ID |
0000-0002-8162-4979 |
|---|---|
| Phone | 0032486911758 |
| kris.martens@kuleuven.be |
Study information
| Study design | Multicentre non-randomsied interventional |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Implementing memory specificity training in routine clinical practices using a web-based self-directed training protocol: an uncontrolled implementation study assessing effectiveness, fidelity and feasibility |
| Study objectives | The use of a web-based self-directed training protocol will lead to the correct implementation of Memory Specificity Training as a part of treatment as usual in clinical practices in Belgium. Three aspects of implementation were assessed; effectiveness defined as a significant change from pre- to post-intervention in memory specificity; fidelity to the protocol by trainers; feasibility as attitudes of stakeholders throughout the implementation process and by the patients post-intervention. |
| Ethics approval(s) | Approved 18/12/2014, Sociaal-Maatschappelijke Ethische Commissie (SMEC) (Social and Societal Ethics Committee of the University of Leuven Oude Markt 13, 3000 Leuven, Belgium; smec@kuleuven.be), ref. G 2014 12 113. Extension approved on 10/02/2016. |
| Health condition(s) or problem(s) studied | Overgeneral autobiographical memory |
| Intervention | Memory Specificity Training, as implemented by the setting itself after using our web-based self-directed training protocol. A group training protocol called Memory Specificity Training. All participants received the intervention. Session 1 of MeST focuses on psycho-education regarding memory problems linked to depression. Three main memory problems are described: reduced levels of concentration, a bias in retrieving mainly negative memories and rAMS. It is explained to participants, within a group setting, that only rAMS can be considered as a risk factor for depression and that training can remediate rAMS to some extent. After this psycho-education, two specificity exercises are conducted within the group. Exercises consist of a presented cue word after which participants are encouraged to retrieve a specific memory and as many details as possible. After each participant writes down their memory, participants help each other with becoming more specific by asking for more details. The session ends by introducing a homework assignment: to re-read the psycho-education, to write down one specific memory for each of ten (positive & neutral) words and to write down one memory of the day at the end of each day. In Session 2, after briefly repeating the psycho-education, homework assignments are discussed. Next, some exercises are conducted together within the group wherein participants need to retrieve two memories for one cue word. Homework assignments after this session consist of writing down two memories for each of ten (neutral & positive) cue words and writing down two memories of the day each day. Session 3 has a similar structure but the exercises now offer word pairs of two opposing valences (e.g. skilful and clumsy). The homework assignment contains two memories for each of ten words (neutral, positive but also negative) and writing down two memories of the day each day. In the fourth and last session, after evaluating the homework assignments, a psycho-education on the STOP-model is given. The aim here is that participants learn to notice when they are overgeneralizing by: signalling to themselves when they are thinking at an overgeneral level; trying to think back to the specific event that prompted the overgeneral thinking; to obtain and generate specific details about that event as much as possible; and, as a last step, try to find an opposite example. After this, some more exercises with opposing cue words are conducted. |
| Intervention type | Other |
| Primary outcome measure | The ability to retrieve specific autobiographical memories was measured using the Autobiographical Memory Test (AMT) pre-intervention and post-intervention. |
| Secondary outcome measures | Depressive symptoms were assessed pre- and post-intervention using questionnaires chosen by the practitioners such as the Patient Health Questionnaire 9 (PHQ-9) and the Beck Depression Inventory II (BDI-II). |
| Overall study start date | 01/03/2016 |
| Completion date | 30/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. Overgeneral autobiographical memory, as assessed with the Autobiographical memory test 2. Aged 18 years or older. |
| Key exclusion criteria | none |
| Date of first enrolment | 01/04/2016 |
| Date of final enrolment | 30/12/2018 |
Locations
Countries of recruitment
- Belgium
Study participating centres
Tienen
3300
Belgium
Diest
3290
Belgium
Melle
9090
Belgium
Pelt
3900
Belgium
Vorselaar
2290
Belgium
Sponsor information
University/education
Oude Markt 13 - bus 5500
Leuven
3000
Belgium
| Phone | +32 16 3 24258 |
|---|---|
| smec@kuleuven.be | |
| Website | https://www.kuleuven.be/english/research/ethics/committees/smec |
"ROR" |
https://ror.org/05f950310 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 30/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The manuscript will be submitted to a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and analysed during the current study will be available upon request from Kris Martens (kris.martens@kuleuven.be). Individual de-identified participant data (IPD) will be available from 6/2019 on and will be available to other researchers upon request. Informed consent from participants was obtained. The datasets per setting and analyses of pre-post differences will be included in subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 29/01/2020 | 29/01/2020 | No | No |
Additional files
- ISRCTN16178120_BasicResults_29Jan2020.docx
- Uploaded 29/01/2020
Editorial Notes
29/01/2020: The following changes have been made:
1. The intention to publish date has been changed from 01/07/2019 to 30/06/2020.
2. The total final enrolment number has been changed from 24 to 30.
3. The basic results of this trial have been uploaded as an additional file.
09/12/2019: The total final enrolment was added.
27/08/2019: Internal review.
10/06/2019: Trial’s existence confirmed by Sociaal-Maatschappelijke Ethische Commissie (SMEC).
