Condition category
Not Applicable
Date applied
09/06/2019
Date assigned
11/06/2019
Last edited
10/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Mr Kris Martens

ORCID ID

http://orcid.org/0000-0002-8162-4979

Contact details

Tiensestraat 102 - box 3712
Leuven
3000
Belgium
0032486911758
kris.martens@kuleuven.be

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

G 2014 12 113 (extension)

Study information

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

Acronym

Study hypothesis

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

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.

Study design

Multicentre non-randomsied interventional

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

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

Phase

Drug names

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 trial start date

01/03/2016

Overall trial end date

30/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Overgeneral autobiographical memory, as assessed with the Autobiographical memory test
2. Aged 18 years or older.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

none

Recruitment start date

01/04/2016

Recruitment end date

30/12/2018

Locations

Countries of recruitment

Belgium

Trial participating centre

Alexianen Zorggroep Tienen
Liefdestraat 10
Tienen
3300
Belgium

Trial participating centre

Sint Annendael Grauwzusters
Vestenstraat 1
Diest
3290
Belgium

Trial participating centre

Karus Melle
Caritasstraat 76
Melle
9090
Belgium

Trial participating centre

Mariaziekenhuis Noord-Limburg
Maesensveld 1
Pelt
3900
Belgium

Trial participating centre

Private Practice - Meeusen
Not displayed due to privacy
Vorselaar
2290
Belgium

Sponsor information

Organisation

Katholieke Universiteit Leuven

Sponsor details

Oude Markt 13 - bus 5500
Leuven
3000
Belgium
+32 16 3 24258
smec@kuleuven.be

Sponsor type

University/education

Website

https://www.kuleuven.be/english/research/ethics/committees/smec

Funders

Funder type

University/education

Funder name

KU Leuven Program Funding Grant PF/10/005.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The manuscript will be submitted to a peer-reviewed journal.

IPD sharing statement:
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.

Intention to publish date

01/07/2019

Participant level data

Available on request

Basic results (scientific)

MeST can be disseminated with a Web-based self-directed training protocol at low-cost. This result might be generalizable to similar brief autobiographical training programs.

Publication list

Publication citations

Additional files

Editorial Notes

10/06/2019: Trial’s existence confirmed by Sociaal-Maatschappelijke Ethische Commissie (SMEC).