Targeting repetitive intrusive suicidal images and thoughts: towards a new suicide prevention strategy (Simagery)
| ISRCTN | ISRCTN17404612 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17404612 |
| Secondary identifying numbers | NTR7563 |
- Submission date
- 22/08/2022
- Registration date
- 26/08/2022
- Last edited
- 30/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Growing evidence shows that the majority of suicidal patients diagnosed with major depression or bipolar disorder report repetitive suicide-related images and thoughts. According to cognitive psychology research, suicide-related images predict suicidality, and repetitive suicide-related images or flash-forwards are therefore essential targets for suicide prevention. There is extensive research evidence from experimental and clinical studies that the vividness of negative as well as positive intrusive images may be reduced by Dual Task (e.g. eye movements) interventions taxing the working memory. The aim of this study is to find out whether eye movements during image retrieval also reduce the severity and frequency of suicidal imagery.
Who can participate?
Psychiatric outpatients aged 18 years and over with elevated levels of depression and suicidal ideation
What does the study involve?
Participants are randomly allocated to receive either treatment as usual (TAU) only or TAU with eye movement dual task (EMDT) add-on treatment. Treatment-as-Usual for depression within the participating mental health care institutions typically consists of (evidence-based) psychotherapy and/or antidepressant treatment. The EMDT add-on intervention involves taxing the working memory while retrieving suicidal intrusions and consists of two to six sessions, each about 1 hour, over the course of 6 weeks.
What are the possible benefits and risks of participating?
Burdens associated are six additional site visits, multiple questionnaires that have to be filled in, and potential psychological discomfort associated with participation (i.e. retrieving suicidal images may be emotionally confronting). A potential risk may be an increase in or worsening of suicidal images and their associated complaints. Potential benefits are a reduction in vividness and frequency of repetitive suicide-related images and thoughts, and reduced suicidality and depression. Moreover, there will be additional supervision of this at-risk group regarding their suicidal ideation, ensuring higher levels of safety.
Where is the study run from?
Vrije Universiteit Amsterdam (Netherlands)
When is the study starting and how long is it expected to run for?
October 2016 to December 2022
Who is funding the study?
ZonMw (Netherlands)
Who is the main contact?
Jael van Bentum, j.s.vanbentum@uu.nl
Contact information
Public
Utrecht University
Heidelberglaan 8
Utrecht
3584 CS
Netherlands
 ORCID ID |
0000-0003-2758-095X |
|---|---|
| Phone | +31 (0)30 2533550 |
| j.s.vanbentum@uu.nl |
Study information
| Study design | Multicenter interventional single-blinded two-armed randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | 42267_PIS_V6_05Mar19_Phase2.pdf |
| Scientific title | Reducing suicidal intrusions in depressed patients through an eye movement dual task in a multicenter parallel two-group randomized design |
| Study acronym | Simagery |
| Study hypothesis | It is hypothesized that eye movements during suicidal imagery retrieval will reduce the intensity and frequency of such imagery, and may be crucial in preventing suicide amongst depressed patients. |
| Ethics approval(s) |
Approved 15/11/2017, The Medical Ethical Review Committee of the Amsterdam UMC, location VUmc (BS7, kamer H-443, Amsterdam, Postbus 7057 1007 MB, Netherlands; +31(0) 20 4445585; metc@vumc.nl), ref: 2017.237 |
| Condition | Suicidal intrusions in psychiatric outpatients with elevated levels of depression and suicidal ideation |
| Intervention | Patients are randomized on a 1:1 basis (stratified for mental health care institution) using a block randomization module in an electronic data capture system (Castor EDC): 1. Comparison group: treatment as usual (TAU) only 2. Intervention group: TAU with eye movement dual task (EMDT) add-on treatment Treatment-as-Usual (TAU): Treatment-as-Usual for depression within the participating mental health care institutions typically consists of (evidence-based) psychotherapy and/or antidepressant treatment. We will ensure that all patients will receive and continue TAU during the course of the study. After each assessment, the TAU mental health care provider will be updated on the patient (with the consent of the patient). EMDT add-on treatment: The treatment will be an add-on module that addresses intrusive suicidal images and can be added to regular treatment. It will consist of max. six sessions each of approximately 1 hour, delivered at the participants’ mental health care center. Trained and supervised intervention psychologists from each participating center will carry out the EMDT sessions. Each session will consist of the following steps: 1. Selection of intrusive suicidal flash-forward target images with related ideation. 2. Consecutive set of eye movements of 30 seconds by 10-second breaks. Between the sets, subjective units of distress scale (SUDS, scale 0-10) are administered to assess the level of distress during imagery. 3. If the image still produces stress, the dual task procedure will be repeated for the target. 4. This procedure is repeated for all target images until all SUDS are at approximately 0, or the EMDT session is coming to an end. |
| Intervention type | Behavioural |
| Primary outcome measure | Frequency (Clinical Interview for Suicidal Intrusions; CISI) and severity (Suicidal Intrusions Attributes Scale; SINAS) of suicidal intrusions measured at baseline, 1-week post-treatment, 3, 6, 9 and 12 months follow up |
| Secondary outcome measures | 1. Suicidal ideation measured using Suicidal Ideation Attributes Scale (SINAS) at baseline, 1-week post-treatment, 3, 6, 9 and 12 month follow-up 2. Depressive symptoms measured using Beck Depression Inventory-II (BDI-II) at baseline, 1-week post-treatment, 3, 6, 9 and 12 month follow-up 3. Quality of life measured using EQ-5D-5L at baseline, 1-week post-treatment, 3, 6, 9 and 12 month follow-up 4. Societal costs measured using Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) at baseline, 3-month, and 12-month follow-up 5. Rumination measured using Ruminative Response Scale (RRS) at baseline, 1-week post-treatment, 3, 6, 9 and 12 month follow-up 6. Hopelessness measured using Beck Hopelessness Scale (BHS) at baseline, 1-week post-treatment, 3, 6, 9 and 12 month follow-up |
| Overall study start date | 01/10/2016 |
| Overall study end date | 12/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 90 |
| Total final enrolment | 91 |
| Participant inclusion criteria | 1. Minimum age of 18 years 2. Score >20 on the Beck Depression Inventory 3. Have suicidal ideation: score >1 on the Suicidal Ideation Attributes Scale (SIDAS) 4. Currently receiving treatment (care-as-usual) at GGZ instelling 5. Adequate proficiency in the Dutch language 6. Have suicidal intrusions that are experienced as a burden |
| Participant exclusion criteria | 1. Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Psychotic disorder diagnosis 2. DSM-IV Depression with psychotic features diagnosis 3. DSM-IV Bipolar disorder diagnosis 4. High dropout risk (i.e. poor response rate when trying to get in contact with the potential participant) In case their current therapist judges the overall complexity of trauma present, he or she can advise not to include despite the participant meeting the inclusion criteria |
| Recruitment start date | 27/11/2018 |
| Recruitment end date | 13/09/2021 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
Utrecht
3524 SH
Netherlands
Domselaerstraat 126 & 128
1093 MB
Amsterdam Noord
Buikslotermeerplein 420
1025 WP
Amsterdam West
Overschiestraat 55
1062 HN
Amsterdam
1093MB
Netherlands
Eindhoven
5626ND
Netherlands
Zwolle
8021EV
Netherlands
Venlo
5912 BL
Netherlands
Nectarinestraat 10
Den Haag
2552 LZ
Netherlands
Gezondheidslaan 65
Locatie Helmond
Wesselmanlaan 25/A, 5707 HA Helmond
Oss
5342 JW
Netherlands
Arnhem
6815AG
Netherlands
Sponsor information
University/education
van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)205985950 |
|---|---|
| secretariaat.knop.FGB@vu.nl | |
| Website | https://vu.nl/nl/over-de-vu/faculteiten/faculteit-der-gedrags-en-bewegingswetenschappen |
"ROR" |
https://ror.org/008xxew50 |
Funders
Funder type
Research organisation
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/02/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data that support the findings of this study are available on request from the corresponding author (J.S. van Bentum; j.s.vanbentum@uu.nl). The data are not publicly available due to their containing information that could compromise the privacy of research participants. The individual participant data that underlie the results reported in the RCT’s published article after deidentification can be obtained upon reasonable request by emailing a proposal to Prof. dr. Marit Sijbrandij (e.m.sijbrandij@vu.nl). To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years following article publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Phase 2 version 6 |
05/03/2019 | 25/08/2022 | No | Yes |
| Participant information sheet | Phase 3 version 5 |
05/03/2019 | 25/08/2022 | No | Yes |
| Protocol article | 09/05/2019 | 25/08/2022 | Yes | No | |
| Results article | 18/07/2024 | 30/08/2024 | Yes | No |
Additional files
- 42267_PIS_V6_05Mar19_Phase2.pdf
- Phase 2
- 42267_PIS_V5_05Mar19_Phase3.pdf
- Phase 3
Editorial Notes
30/08/2024: Publication reference added.
08/01/2024: The intention to publish date was changed from 31/12/2022 to 01/02/2024.
01/09/2022: The public contact's details have been changed.
25/08/2022: Trial's existence confirmed by the Medical Ethical Review Committee of the Amsterdam UMC.
