Posttraumatic stress disorder in people with dementia: study protocol

ABSTRACT

Background: Posttraumatic stress disorder (PTSD) is considered an independent risk factor for dementia. Despite the (clinical) evidence that PTSD is associated with neuropsychiatric symptoms in people with dementia, studies on its prevalence and clinical manifestation are limited, and their quality is affected by the lack of a structured method to diagnose PTSD in this population. The primary aim of the current study is to validate the ‘TRAuma and DEmentia’ interview as a diagnostic tool for PTSD in people with dementia and to test feasibility of EMDR treatment for people with PTSD and dementia.

Methods: This prospective multi-centre study is divided into two parts. In study A, 90 participants with dementia will be included to test the criterion validity, inter-rater reliability and feasibility of the ‘TRAuma and DEmentia’ interview. In study B, 29 participants with dementia and PTSD will receive eye movement desensitisation and reprocessing therapy by a trained psychologist, and 29 participants with dementia and PTSD will be placed on the waiting list control group.

Conclusion: This study aims to improve the diagnostic process of PTSD and to assess the effects of eye movement desensitisation and reprocessing treatment in people with dementia living in Dutch care facilities.

Trial registration: NL70479.068.20 / METC 20-063 / OSF registration: https://doi.org/10.17605/OSF.IO/AKW4F

HIGHLIGHTS

• This study protocol describes a two-part study on posttraumatic stress disorder in people with dementia in Dutch care facilities.

• The primary aim of the study is to validate the ‘TRAuma and DEmentia’ interview as a diagnostic tool for posttraumatic stress disorder in people with dementia.

• This study aims to test the feasibility of an evidence-based treatment for people with dementia and posttraumatic stress disorder in the form of eye movement desensitisation and reprocessing therapy.

Antecedentes: El trastorno de estrés postraumático (TEPT) es considerado un factor de riesgo independiente para la demencia. A pesar de la evidencia (clínica) de que el TEPT está asociado con síntomas neuropsiquiátricos en personas con demencia, los estudios sobre su prevalencia y manifestación clínica son limitados, y su calidad se ve afectada por la falta de un método estructurado para diagnosticar el TEPT en esta población. El objetivo principal del presente estudio es validar la entrevista ‘TRAuma and Dementia’ como herramienta de diagnóstico para el trastorno de estrés postraumático en personas con demencia y probar la viabilidad del tratamiento EMDR para personas con TEPT y demencia.

Métodos: Este estudio prospectivo multicéntrico se divide en dos partes. En el estudio A, se incluirán 90 participantes con demencia para probar la validez de criterio, la confiabilidad entre evaluadores y la viabilidad de la entrevista ‘TRAuma and Dementia’. En el estudio B, 29 participantes con demencia y trastorno de estrés postraumático recibirán terapia de reprocesamiento y desensibilización por movimientos oculares por parte de un psicólogo capacitado, y 29 participantes con demencia y trastorno de estrés postraumático se incluirán en el grupo de control de lista de espera.

Conclusión: Este estudio tiene como objetivo mejorar el proceso de diagnóstico del TEPT y evaluar los efectos del tratamiento de reprocesamiento y desensibilización por movimientos oculares en personas con demencia que viven en centros de atención holandeses.

KEYWORDS:

• Dementia
• PTSD
• EMDR
• traumatic life-events
• trauma
• care home
• clinical practice

PALABRAS CLAVE:

• Demencia
• TEPT
• EMDR
• acontecimientos vitales traumáticos
• trauma
• residencia de ancianos
• práctica clínica

1. Background

Traumatic life events can result in severe psychiatric symptoms, of which posttraumatic stress disorder (PTSD) is the most prevalent. The lifetime prevalence of PTSD in the general population is 7%−8% (de Vries & Olff, 2009). However, in older adults, the diagnosis of PTSD is less frequent (1%−3%), compared with younger adults (Kessler et al., 2017; Reynolds et al., 2015).

The main feature of PTSD in the general population is intrusive symptoms after a traumatic event. Additionally symptoms such as hyperarousal, changes in mood or cognition and avoidance of trauma-associated triggers are seen in people with PTSD (American Psychiatric Association, 2013). Older adults with PTSD experience a high disease burden, higher risk of suicide attempts, and higher risk of anxiety, compared with older adults without PTSD (Nichter et al., 2019). In addition, PTSD has a negative effect on quality of life (Lamoureux-Lamarche & Vasiliadis, 2017). There is also a high caregiver burden related to the increased symptom severity in PTSD (Calhoun et al., 2002). PTSD is associated with chronic stress and cognitive dysfunctions, and it has been described as an independent risk factor for cognitive decline and dementia (Gunak et al., 2021). Eye movement desensitisation and reprocessing (EMDR) is a validated treatment modality for PTSD in the general population (Novo Navarro et al., 2018). It is a protocolised psychological treatment method to reduce the distress related to an experienced traumatic life event. Recent studies have shown that it is also effective in the older population without dementia (Gielkens et al., 2022). Moreover, treatment of PTSD reduces the level of frailty in older people without dementia (Gielkens et al., 2022). Existing case reports show that EMDR may be a feasible treatment modality for people with dementia and PTSD, with the differing case reports describing the dementia severity as anywhere from mild – severe (Ahmed, 2018; Amano & Toichi, 2014; Ruisch et al., 2023; Van Der Wielen et al., 2019). To the best of our knowledge, there are no prospective studies on EMDR for people with PTSD and dementia.

To indicate the appropriate treatment of PTSD, it is important to recognise PTSD in people with dementia. Older adults more frequently present with a sub-threshold diagnosis of PTSD (a 6-month prevalence of 13.1%), compared with a predominantly younger population (a six-month prevalence of 6.6%) (McLaughlin et al., 2015; van Zelst et al., 2003). In a sub-threshold diagnosis of PTSD, a person meets two or three of the Diagnostic and Statistical Manual of Mental Disorders (5th edition, DSM-5) criteria (McLaughlin et al., 2015). Van Dongen et al. (2022) suggest that people with dementia and PTSD might also exhibit different symptoms, compared with healthy adults. For example, avoidance is absent in most cases. Hence, the diagnosis is often ‘sub-threshold’ (van Dongen et al., 2022).

Following the previously highlighted studies describing feasibility and effectivity of EMDR in older people, the need to analyse feasibility of EMDR in people with dementia arises (Gielkens et al., 2022). An international delphi study finds importance in developing a diagnostic tool for PTSD in people with dementia, due to the different clinical presentation (Havermans, van Alphen, et al., 2023). The TRAuma and DEmentia (TRADE) interview aiming to diagnose PTSD in people with dementia, is developed together with experts in the field but it is not yet validated (Havermans, Van der Velden-Daamen, et al., 2023). The TRADE-interview combines anamnestic information, informant information (of someone that knows the person well) and clinical observations from formal caregivers to determine whether PTSD is present and its severity (https://maastrichtuniversity.eu.qualtrics.com/jfe/form/SV_0AOLXSjGHsmEVVA). The TRADE-interview in its current form does not specifically diagnose sub-threshold PTSD because this term is based on the DSM-5 criteria. As described above we hypothesise these criteria are not suitable for people with dementia. The aim of part A of the current study is to test the validity of the TRADE-interview in people with dementia in clinical practice. The criterion validity will be tested using clinical examination as a comparison standard.

In this article we describe the protocol for a study that aims to (A) test the criterion validity, inter-rater reliability and feasibility of the TRADE-interview; and (B) measure the feasibility of EMDR treatment in people with PTSD and dementia in nursing homes and a mental health care facility, referred to as Dutch care facilities.

2. Methods/Design

This study follows a multi-centre cross-sectional approach and is divided into two parts. The first part (study A) will assess the diagnostic process (TRADE-interview). The second part will evaluate treatment of PTSD using EMDR (Figure 1).

Figure 1. Overview of the design for study A and B. EMDR: Eye movement desensitisation and reprocessing, PTSD: Posttraumatic stress disorder.

2.1. Setting

The study will include participants from five nursing home organisations providing long-term care for people with dementia as well as one regional mental health care facility. Together, these places are referred to as Dutch care facilities. We have chosen these organisations based on their location. These are 6 important stakeholders in the care for residents with dementia in the Netherlands. By including two kinds of facilities, we hope to increase generalizability of the results. These organisations all have multiple locations in the southern part of the Netherlands. People with dementia receive day-to-day care from a team of caregivers and nurses and are supported, where necessary, by (para)medical professionals, such as physiotherapists, psychologists and physicians.

2.2. Study population and sample

The inclusion criteria for studies A and B are: (1) people with a DSM-5 diagnosis of dementia and (2) people with an informant, or someone who has known the participant since before their diagnosis of dementia and can assist in insights of the past, available for data collection. The exclusion criteria for studies A and B are: (1) people with an advanced form of dementia, referred to as stadium 3 or 4 according to the scale of Verdult and Van der Kooij (Finnema et al., 2015), meaning a person can be disoriented at times, but also has moments in time where they are oriented in person and place; (2) people or informants who do not speak the Dutch language; (3) people with resistance behaviour possibly indicating they do not wish to participate regardless if they say otherwise; and (4) major medical or psychiatric comorbidities. For study B, an additional inclusion criterion is a diagnosis of PTSD and an additional exclusion criterion is substance abuse disorders.

2.2.1 Sample size calculation

To test the inter-rater reliability of the TRADE-interview in study A, 20 measurements (based on a rule of thumb) are used and independently co-rated by two raters. This rule of thumb is based on a calculation with an intraclass correlation coefficient (ICC) of 0.60 and a power of 80% (Cicchetti, 1994). Based on this, at least 15 measurements are sufficient (Bujanga & Baharum, 2017). Figure 1 gives an overview of the design for studies A and B.

For criterion validity and feasibility of the TRADE-interview in clinical practice, an additional 70 participants will be included. MedCalc® was used for the power calculation (MedCalc®, 2015). This software uses the method described by Hanley and McNeil (1982) for the power calculation based on receiver operating characteristic (ROC) curve analysis (Hanley & McNeil, 1982). Given an α value of 0.05, power of 0.8 and an area under the curve (AUC) of ≥ 0.60 (an AUC of 0.60 can be regarded as sufficient diagnostic accuracy) (Steyerberg EW et al., 2012), the necessary sample size for the current study is 90.

For study B, a total of 58 participants will be included. 29 people will receive EMDR, and 29 people will be part of the waiting list control group (WLC). The amount of people included is based on a meta-analysis of the efficacy of EMDR for people with PTSD (with PTSD symptom rating as the outcome variable), in which the average Hedges’ g effect size is 1.01 (Watts et al., 2013). Large effect sizes have also been reported by (Wagenmans et al., 2018) (Cohen's d = 1.52-2.09) and by (Van Woudenberg et al., 2018) (Cohen's d = 1.87). (Gielkens et al., 2022) proved that these large effect sizes are also seen in older adults. G*power was used to calculate the required sample size, using PTSD symptoms (based on the TRADE-interview) as the major outcome. Considering the parameters, a t-test was used to determine the difference between two independent means with an effect size of 1.01 (Watts et al., 2013), an α value of 0.05 and a power of 0.95. Each treatment arm (the EMDR and WLC groups) would have to have at least 29 participants (a total of 58 participants). In addition, two-tailed t-tests to determine the difference between two dependent means will have an effect size of 0.30, an α value of 0.05 and power of 0.80 (Gielkens et al., 2021).

2.2.2 Participant selection

The care organisations will provide different locations. The research team will advise the research representatives of the different care organisations to choose a location with multiple residential wards. At the location, the participants will be included via convenience sampling. The participants and their legal representatives will be asked to provide informed consent. If the legal representative and participants feel another person would be best suited as informant in the study, the informant shall also be asked to sign informed consent.

3. Study protocol

We will describe the primary outcome measures of this study below. The secondary outcome measures are provided in the Appendix (supplementary material).

3.1. Study A

Study A aims to test the criterion validity, inter-rater reliability and feasibility of the TRADE-interview and to describe the target population for this study. Data will be collected from the participants enrolled in study A over the course of maximum 4 days, within a period of 3 weeks. The clinical diagnoses (PTSD present or absent) of the practitioner will be compared with the results of the TRADE-interviews (measure procedure is further clarified below). The investigators will be blinded, regarding the clinical diagnosis of the participants at the time of the TRADE-interview.

3.1.1 Measurements in study A

The different measurements that will be done in study A are described below. Tables 1 and 2 present an overview of the instruments that will be applied during the course of the study.

Table 1. Overview of the measurements during the course of study A.

Four-week period
	Conducted by	Day 1	Day 2	Day 3	Day 4*
Patient
TRADE-interview	Researcher	x			x
Clinical psychiatric investigation	Psychologist or Psychiatrist			x
Demographic variables	Location coordinator	x
Informal caregiver
TRADE-interview	Researcher	x			x
Formal caregiver
TRADE-interview	Researcher	x			x

Note: TRAuma and DEmentia (TRADE).

*Day 4 is only done in the first 20 inclusions.

Table 2. Overview of the measurements during the course of study B.

Four-months
	Conducted by	Screening	Start	1 month	2 months	3 months	4 months
Patient
TRADE-interview	Researcher	x	x	x	x	x	x
Clinical psychiatric investigation	Psychologist or Psychiatrist	x
Demographic variables	Location coordinator	x
Informal caregiver
TRADE-interview	Researcher	x	x	x	x	x	x
Formal caregiver
TRADE-interview	Researcher	x	x	x	x	x	x

Note: TRAuma and DEmentia (TRADE).

3.1.1.1 PTSD symptoms

Using the TRADE-interview, the presence of PTSD symptoms and its severity will be assessed (https://maastrichtuniversity.eu.qualtrics.com/jfe/form/SV_0AOLXSjGHsmEVVA) (Havermans, Van der Velden-Daamen, et al., 2023). The semi-structured interview consists of an interview with the participant, informant information and a clinical observation on the presence of PTSD symptoms and their severity in the past month. In the clinical observation the formal caregiver is asked if and to what extent the following symptoms are present: intrusive symptoms (nightmares, flashbacks) avoidance, negative feelings, and changes in arousal (irritability, aggression, reckless or self-destructive behaviour, overly vigilant, heightened startle response and insomnia). The outcomes are combined to form a total score indicating the presence or absence of PTSD in the person with dementia. A patient is considered positive for PTSD when at least one sub-criterion of the main criteria A, B and E is met in one of the elements (anamnestic, informant or observational information). In addition, the duration of the disorder must be longer than 1 month and cannot be explained in any other way (criteria F, G and H; [American Psychiatric Association, 2013]). In 20 participants, the TRADE-interview will be repeated by a second researcher to test inter-rater reliability. This will happen within the three-week period of data collection and not on the same day as the initial TRADE-interview.

3.1.1.2 Clinical psychiatric investigation

For the convergent criterion validation of the TRADE-interview, a clinical psychiatric investigation will be used as the comparison standard. This is to increase transferability to current clinical practice in nursing homes. The presence of a clinical diagnosis of PTSD will be assessed by a psychiatrist or psychologist, who will use the standardised clinical investigation that they use in daily practice. The professional will indicate the presence or absence of each DSM-5 criteria, the final diagnosis and an EMDR indication. Tools such as the CAPS-5 or SCID are not applied in this study, as these tools are not validated in people with dementia and the staff in nursing homes is not trained in the application of these tools (Havermans, van Alphen, et al., 2023).

3.1.1.3 Demographic variables

Demographic variables will be collected to describe the population. Data concerning ethnicity, age, gender, (neuro)psychiatric history (including comorbid disorders), somatic disorders, marital status, children, education and employment history, social network, weight (loss), height, use of alcohol and smoking will be collected. Besides, the indication for residency in a long-term care facility, according to the Dutch indication system for long-term institutional care (Residency due to forestanding somatic, cognitive or psychiatric diagnosis), and the use of involuntary care, according to the Compulsory Mental Healthcare Act, will be registered (Hendriks & Frederiks, 2019). Involuntary care includes care in which the person’s freedom is restricted (such as locked doors, limited use of communicatory devices, or psychofarmological medication outside of protocol).

3.1.2 Statistical analysis

First, a quantitative analysis will be performed. The results of the TRADE-interview will be compared with the results of the clinical diagnosis to assess the criterion validity of the TRADE-interview. The cut-off score, sensitivity and specificity of the TRADE-interview will be calculated based on receiver operating characteristic (ROC) curve analyses. The ROC curve that best fits the data will determine the sensitivity and specificity. Significance will be set at 0.05 (two tailed). Analyses will be performed with SPSS Statistics (IBM Corp., Armonk, NY, USA). Attrition is expected to be low in section A as the inclusion takes place over a short period of time. Demographic statistics of continuous outcomes will be presented by disorder category (PTSD vs non-PTSD in study A) and include sample size, mean, median, standard deviation, minimum and maximum.

3.2. Study B

Study B will investigate the feasibility of EMDR treatment in people with dementia and PTSD. Data will be collected over a period of 4 months. The methods and design are based on a previous study on the feasibility of EMDR in older adults carried out by our research group (Gielkens et al., 2022). Measurements taken during and after EMDR treatment in people with dementia will be compared with measurements from the WLC group (Table 2). To test treatment fidelity, a total of three EMDR treatments will be recorded and evaluated by other EMDR practitioners. There is a guideline available for EMDR therapists. Once every 3 weeks, the EMDR therapists will have an intervision session to guarantee treatment quality and progress. The participants and their caregivers will be asked to provide their permission.

3.2.1 Treatment with EMDR

EMDR will be conducted by health care practitioners who are trained in administering this therapy. EMDR is a validated psychological treatment for PTSD and is part of a standardised treatment algorithm (Bisson, 2007; Seidler & Wagner, 2006). EMDR is a psychotherapeutic approach that aims to resolve symptoms resulting from disturbing life events (Shapiro, 2002). This study will use the Dutch translation of the EMDR (standard) protocol developed for children and adolescents, with cognitive age-appropriate modifications. Clinical experience indicates it may represent a better fit for people with dementia as the explanations are shorter and less complex (De Roos et al., 2015; Gielkens et al., 2018). Bilateral visual or sensory stimulation will be used. As not all older adults can complete a 90-minute session, the sessions will be reduced to 30–60 min, with the aim of one session per week. The first two sessions will also consist of psychoeducation for patients, caregivers and the formal caregivers about the relation between trauma and the symptoms seen in the person included; trauma effects; a rationale for the EMDR treatment; gathering information; and treatment preparation. The psychoeducation to the formal caregivers is done as deemed fit for the EMDR therapist and no guideline is provided. There is no pre-determined minimum number of sessions (Amano & Toichi, 2014). The number of sessions is adapted to each individual, according to the number of traumatic events being processed, the individual’s capacity and clinical feasibility. A maximum of 10 sessions is set. This is based on clinical feasibility in this population, counting an average of one session per week for the three-month study period. The number of EMDR sessions will be registered. All assessments will be conducted by independent researchers who will not be responsible for the EMDR treatment.

3.2.2 Measurements in study B

3.2.2.1 PTSD symptoms

Using the TRADE-interview, the presence of PTSD and its symptoms will be assessed (Havermans, Van der Velden-Daamen, et al., 2023). In the interview the presence and absence of PTSD symptoms will be questioned in the person, their informant and a formal caregiver, including the observed severity of these symptoms. The TRADE-interview will be administered before the start of the EMDR sessions, and during the course of the EMDR sessions the interview will be repeated every month to monitor the effects of the EMDR treatment.

3.2.3 Statistical analysis

For study B, the general linear model (GLM) repeated measures procedure will be used. The between-subject factors will be grouped based on whether the participants received EMDR. The within-subject factor is time. The relationship between the scores for the TRADE-interview and the scores for the main outcome variables will be investigated by using Pearson’s product moment and regression analyses. Significance will be set at 0.05 (two-tailed). Analyses will be performed with SPSS Statistics (IBM Corp.).

As study B takes place over the course of 4 months, attrition is expected to be higher compared to section A. As the main outcome is feasibility, we will keep track of drop out rates including the cause of drop out. ‘Missing completely at random’ data will be handled using random forest plot method.

Demographic statistics of continuous outcomes will be presented by treatment category in study B (EMDR vs WLC) and will include sample size, mean, median, standard deviation, minimum and maximum.

3.3. Data management for studies A and B

A data safety management board will be appointed from the Clinical Trial Centre Maastricht (CTCM). A data management plan will be created and the data will become available according to the FAIR principles (Boeckhout et al., 2018). The data collected during the study period will be entered into Castor. All adverse events reported spontaneously by the person, observed by the investigator or observed by his staff will be recorded in Castor. The investigator site files will be kept at the study locations in a locked cabinet only accessible by the research team.

3.4. Ethical considerations for studies A and B

The study protocol complies with the Declaration of Helsinki and has been granted approval from the Medical Ethics Committee of Maastricht University/Academic Hospital Maastricht (NL70479.068.20 / METC 20-063). The study is registered in the Open Science Framework (OSF) trial register.

4. Discussion

This study will provide insight into the diagnosis and treatment of PTSD in people with dementia in Dutch care facilities. Study A will analyse validity of the TRADE-interview as a diagnostic tool for PTSD in people with dementia living in Dutch care facilities. This validation would help health care professionals working with people with dementia to talk about traumas and the effect on the patient, and it would open the door to trauma-focused treatment. We expect study B to provide insight into the feasibility of EMDR in people with mild-to-moderate dementia in Dutch care facilities.

Prospective research on the diagnosis and treatment of PTSD has not been performed in people with dementia, possibly due to the challenges of research in this population, such as achieving (informant) information about the past, the role of cognitive decline in this population and the challenges associated with obtaining informed consent. The limitations of the current study are the high dependence on informant data (via treatment effect measurement using TRADE-interview) to determine the treatment effects and the recruitment of participants in different care settings with different levels of care burden. Selection bias may occur by only recruiting people with mild-to-moderate dementia in whom no resistance behaviour is expected. We aim to validate the TRADE-interview using clinical examination as a comparison standard supported by the DSM-5. We believe that the sensitivity of the DSM-5 criteria in people with PTSD and dementia is not high enough due to different symptom presentation (van Dongen et al., 2022) and the clinical examination is not protocolised. Thus, the results should be interpreted with caution, considering this context. The study of van Dongen et al. (2022) showed that avoidance seems to be a rarely present symptom (only 3/30 cases), possibly because it is not recognised, not needed in the structured and protected environment or people do not have the cognitive ability to avoid a trauma related thought. Because of this, most people with dementia will not be diagnosed with PTSD when assessed with the DSM-5 criteria of PTSD, as they do not meet all the main DSM-5 criteria.

Regarding the treatment with EMDR, there is a high level of independence for the psychologists performing the EMDR. We have not set lower limits of treatment sessions to stay as close to ‘practice as usual’ as possible, and this must be considered when interpreting the results. Nevertheless, the results of this study will hopefully provide tools for diagnostics and treatment.

This study differs from other studies due to the chosen population: other studies have not included people with dementia living in nursing homes and mental health care facilities. This population is provided with full-time care, giving us unique insight into the effects of the treatment from the formal caregiver’s perspective. Additionally, this project forms a bridge between mental health care and long-term care facilities for older adults by building a transmural academic workplace.

Acknowledgements

We would like to acknowledge; Cicero zorggroep, Envida, MeanderGroep, Mondriaan, Sevagram and Zuyderland care for their participation and sponsoring.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

This work is partially supported by EMDR-Europe under grant number 2019-04, Alzheimer Nederland under grant number WE.09-2021-02/u210099/MB/be, and Universiteitsfonds Limburg/SWOL under grant number CoBes20.050.