Edited by: Olusegun Baiyewu, University of Ibadan, Nigeria
Reviewed by: Suzie Xu Wang, Leeds Beckett University, United Kingdom; Alexandra Wuttke-Linnemann, Center for Mental Health in Old Age, Landeskrankenhaus, Germany; Chung-Ying Lin, National Cheng Kung University, Taiwan
This article was submitted to Aging Psychiatry, a section of the journal Frontiers in Psychiatry
This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
Dementia is considered a global health concern, affecting over 50 million people worldwide and is estimated to increase to 131.5 million by 2050 (
Although patients with early stage dementia are not typically described as terminally ill, they are nevertheless, in their final phase of a consciously aware existence. While palliative and spiritual care are on the increase worldwide (
Dignity Therapy is a structured, individualized psychosocial intervention, developed to help patients with terminal illnesses to cope with the imminent end of their lives. Dignity Therapy was originally developed to reduce psychosocial and spiritual or existential distress in terminally ill cancer patients (
Research on Dignity Therapy in terminally-ill cancer patients started a decade ago and has since been conducted in several countries, including Canada (
Dignity Therapy has also been carried out with patients suffering from a motor neuron disease (
Like the terminally ill individuals, patients with early stage dementia often face existential and spiritual issues related to loss, disability, and death (
The aim of this study was firstly to determine the feasibility and acceptability of the intervention, and secondly—for the first time—to detect the preliminary efficacy of Dignity Therapy in patients with early stage dementia in a randomized, waitinglist-controlled clinical trial (RCT). The third aim of this study was to test whether Dignity Therapy might have a beneficial effect on family members (partner, relative) or close friend in terms of psychological burden and quality of life. Based on prior research (
Because this study primarily focussed on feasibility and acceptability of Dignity Therapy in patients with early stage dementia, we chose a randomized, waiting list controlled design to achieve a large group of participants who received the intervention. The study was funded by Porticus foundation that did not have any role in the design or conduct of the study, analysis of the data, or preparation of the manuscript. The trial was registered at ClinicalTrials.gov (NCT03692988).
Patients were recruited at the University Geriatric Outpatient-Center Waid, Switzerland, between March 2019 and March 2021. Patients (all of them outpatients) were eligible for participation in the trial if they were aged 18 years or older, had been diagnosed with early stage dementia according to the Clinical Dementia Rating instrument (CDR® score between ≥0.5 and ≤ 1.5), language proficiency, and had a study partner (romantic partner, relative or close friend) willing to participate in the study. Family members, who had not necessarily to be an informal caregiver, were present during the intervention and were integrated into the therapeutic process. They were allowed to answer questions as well and to assist patients if required. All patients and family members provided written informed consent (IC). The study protocol was approved by the local ethics committee (BASEC-Nr. 2018-01097).
Physicians at the study site consecutively made patients, diagnosed with (very) mild dementia as indicated by a score on the Clinical Dementia Rating (CDR) (
The interested patients were then contacted by the study coordinator within a few days for a screening visit. In the screening visit the study coordinator reassured for accuracy of the inclusion/exclusion criteria and ensured that invited patients and family members were fully informed about the purpose, procedure, potential risks, and benefits of participating in the study, including not receiving any remuneration for study participation. After a further period of at least 24 h to consider and discuss their participation, the IC forms were dated and signed by both participants. Finally, participants were scheduled for the baseline assessment and thereafter randomly assigned to one of two study conditions (
Study timeline from baseline assessment to the 1-week post-treatment and 3-months follow-up. T0, Baseline; T1, post-treatment; T2, 3-months follow-up; T3, post-treatment delayed group; T4, 3-months follow-up delayed group; CDR, Clinical Dementia Rating; HADS, Hospital Anxiety and Depression Scale.
The week after the baseline assessment (T0), the first Dignity Therapy session followed. The patient was accompanied by the study partner during the interview. The intervention was conducted by health care personnel trained in Dignity Therapy, who were neither involved in the study organization nor data management.
Dignity Therapy is conceptualized as multi-dimensional psychosocial intervention for patient-centered care, including 10 core questions that guide an interview. The questions invite a discussion of meaningful events, achievements, and social roles. The questions also encourage patients to express things that remained unsaid and pass on life's lessons and personal wishes to next of kin. For this study the core questions developed by Chochinov (
After the second session, participants (patients and family members) again received the brief 14-item questionnaire designed to assess states of anxiety and depression (HADS), as well as an Dignity Therapy Evaluation Questionnaire (DTEQ) to assess satisfaction with the intervention (see
Patients in the delayed treatment group completed the standard assessments (T0, T1, and T2), but received no Dignity Therapy in addition to counseling provided as usual. They constituted a control condition enabling the comparison of data with the intervention group. After the waiting period and a completed follow-up assessment (T2, week 15) the delayed treatment group participants received the same intervention as the immediate group. The follow-up assessment in this group simultaneously served as the baseline assessment of the delayed intervention. To also determine the effect of the Dignity intervention, participants of the delayed condition were asked to once more complete a post-treatment (T3) in week 19, and a follow-up assessment (T4) 3 months (week 30) after the intervention.
Family members/close friends of both groups also completed assessments at T0 to T4, however they did not receive the PDI and the FACIT-Sp-12.
The primary outcome of this trial was the feasibility and acceptance of Dignity Therapy provided to a sample of patients with early stage dementia and their partners/relatives in Switzerland. Feasibility was defined by the number of participants who signed ICs in proportion to the number of eligible subjects who were invited to participate in the study. Because this was the first time to apply this intervention in this specific clinical population, we considered Dignity Therapy as feasible if at least 40% of all eligible subjects consented. Acceptability was defined as the number of drop-outs occurring after enrollment and signing the IC. If the drop-out rate was 25% at most, we considered Dignity Therapy as well-accepted. Furthermore, to assess an additional aspect of acceptance we developed a nine items (Likert scale 1–5) comprising questionnaire for overall treatment satisfaction (DTEQ) with a minimum score of nine and maximum score of 45. In such a range a mean score of 36 (quite a bit satisfied) can be regarded as typical in health care (
For the secondary outcomes we used standardized and validated self-report measures to determine the efficacy of Dignity Therapy in the immediate treatment group compared to the delayed condition in terms of psychological burden (HADS), sense of dignity (PDI), quality of life (WHOQOL-BREF), and spiritual well-being (FACIT-Sp-12). PDI and FACIT-Sp-12 were used only in patients and not in family members. All questionnaires have been used in comparable samples in prior research with limited (HADS) (
The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that was originally developed for use with patients in non-psychiatric hospitals (
The Patient Dignity Inventory - German Version (PDI-G) is a valid and reliable 25-item questionnaire that specifically assesses dignity-related issues and identifies end-of-life dignity-related distress (
WHO Quality of Life Questionnaire (WHOQOL-BREF): The quality of life of partners/family members was assessed with the WHOQOL-BREF, which is not specific to any illness. The 26-item questionnaire encompasses the domains of physical and psychological health, social relationships, and environment, as well as overall quality of life and general health (
Functional Assessment of Chronic Illness Therapy Spiritual Wellbeing Scale (FACIT-Sp-12): The FACIT-Sp-12 (
To determine the sample size in advance a power analysis was performed considering hypotheses regarding feasibility, acceptance, and treatment satisfaction in the whole sample of patients as well as symptom reduction in the RCT condition. About feasibility a minimum of 38 screened patients would have to be invited for participation to conclude that an expected preferable rate of 60% consenting patients is significantly higher than a minimal rate of 40% with a power = 0.8 (type I error = 0.05, one-sided). As to acceptability we expected a drop-out rate after informed consent of 10%. Should the drop-out rate be 25% or more, Dignity Therapy would be considered as badly accepted. With a minimum of 42 patients entered the study (signed informed consent) it would be possible to conclude that the expected drop-out rate is significantly lower than 25% with 80% power (type I error = 0.05, one-sided). Additionally, we expected the overall satisfaction with Dignity Therapy not to be significantly lower than a reference value (reference = 36, SD = 6.0, scale ranging from 9 to 45). At most, the difference should correspond to an effect size of Cohen's d = 0.5. For the given effect size with a power of 80% and a type I error = 0.05 (one-sided), a total sample size of 27 patients would be required. Presuming a moderate symptom reduction (HADS) an effect size of Cohen's d = 0.5 in the intervention group, compared to no effect in the waiting list group, a sample size of 64 patients per group (128 patients in total) would be needed to generate a significant interaction effect between group and time with a power = 0.8 and type I error = 0.05. Given that the waiting list controlled design was secondary and the sample size calculations further above, we reduced the sample size to 24 patients per group (48 patients in total) which halved the power to 40% in the RCT condition. However, in a combined group consisting of both arms (single-armed intervention study), a significant decrease in symptom load after intervention could be determined with a power of 92% (expected effect: Cohen's d = 0.5, type I error = 0.05). Because we expected 10% of participants to drop out, recruiting 54 patients in total (27 per group) was necessary. Power and sample-size analyses were calculated with Stata 16.1 (one-sample proportion test, one-sample mean test, repeated-measures analysis of variance).
Descriptive statistics of demographic, clinical and psychological variables were calculated with mean, standard deviation (SD), and percentage (%) as appropriate. To calculate the 95% confidence intervals (CI95%) for the proportions of patients consenting to participate (feasibility) and dropping out after informed consent (acceptance) bootstrapping based on 1,000 bootstrap samples was performed. Overall satisfaction with Dignity Therapy was tested against the expected reference score using one-sample
Under the condition of a randomized controlled trial (RCT) linear mixed model analyses for all available outcome data were used to test the effect of group (i.e., immediate vs. delayed condition), time (baseline, post-treatment, 3-months follow-up) and group*time interaction on outcome measures. Based on estimated marginal means
Between March 2019 and March 2021, a total of 86 eligible patients were registered and afterwards contacted by the study coordinator. Due to some changes in the team of recruiting physicians and a recruiting stop from March 2020 to May 2020 because of the pandemic, we had to retrospectively estimate the exact number of invited participants. The main recruiting physician invited a total of 65 suitable patients, of whom 40 (61.5%) agreed to participate (i.e., willingness to be contacted by the study coordinator for full information). To estimate all eligible participants, we used the exact numbers of the main recruiting physician who invited a total of 65 eligible patients, of whom 40 (61.5%) agreed to participate. Based on the final registered participants (
CONSORT diagram of participant flow. aDue to changes in study personnel and pandemic problems the number of screened patients had to be estimated retrospectively from exact numbers of the main recruiting physician. bRefused after detailed information by phone about study. Reasons for refusal: study requirements such as filling in questionnaires (
Demographic and clinical characteristics of subjects with early stage dementia (
Age (years) | 81.2 (70–91) | 5.7 | 77.8 (63–93) | 6.7 | 0.051 | 70.2 (39–90) | 12.9 |
CDR |
0.92 (0.5–1.5) | 0.26 | 0.96 (0.5–1.5) | 0.25 | 0.244 | n.a. | n.a. |
Female | 16 | 57.1 | 12 | 46.2 | 34 | 63.0 | |
Male | 12 | 42.9 | 14 | 53.8 | 0.586 | 20 | 37.0 |
Married | 16 | 57.1 | 20 | 76.9 | 45 | 83.3 | |
Cohabitation | 1 | 3.6 | 0 | 0.0 | 1 | 1.9 | |
Divorced | 3 | 10.7 | 1 | 3.8 | 1 | 1.9 | |
Widowed | 8 | 28.6 | 3 | 11.5 | 2 | 3.7 | |
Single | 0 | 0.0 | 2 | 7.7 | 0.138 | 5 | 9.3 |
Obligatory | 4 | 14.3 | 3 | 11.5 | 4 | 7.4 | |
Apprenticeship | 10 | 35.7 | 10 | 38.5 | 30 | 55.6 | |
High school | 5 | 17.9 | 2 | 7.7 | 1 | 1.9 | |
College/university | 9 | 32.1 | 11 | 42.3 | 0.729 | 18 | 33.3 |
Full | 0 | 0.0 | 0 | 0.0 | 14 | 25.9 | |
Part | 4 | 14.3 | 1 | 3.8 | 19 | 35.2 | |
Retired | 24 | 85.7 | 25 | 96.2 | 0.353 | 21 | 38.9 |
Catholic | 10 | 35.7 | 7 | 26.9 | 8 | 14.8 | |
Reformed | 12 | 42.9 | 12 | 46.2 | 30 | 55.6 | |
Other Christian | 0 | 0.0 | 1 | 3.8 | 1 | 1.9 | |
No confession | 5 | 17.9 | 5 | 19.2 | 13 | 24.1 | |
Other | 1 | 3.6 | 1 | 3.8 | 0.920 | 2 | 3.7 |
Along the study six participants (11.1%; CI95%: 3.7–20.4%) dropped out, one in the immediate (before the intervention, felt overstrained by questionnaires) and five in the delayed treatment group (all before intervention: one patient died, three felt overstrained by study requirements, one reconsidered participation).
Overall treatment satisfaction, assessed by our nine items comprising questionnaire (DTEQ) with a minimum score of nine and maximum score of 45, was high (
Results for all secondary outcomes are presented in
Secondary outcomes in RCT condition (immediate treatment compared to delayed treatment group).
Immediate group ( |
HADS total | 8.39 (1.15) | 8.19 (1.30) | 5.70 (0.92) | −2.69 (0.85) | −4.40 to −0.99 | 0.003 |
PDI | 38.1 (2.43) | – | 31.5 (2.47) | −6.56 (1.63) | −9.83 to −3.29 | <0.001 | |
Qol-physical | 79.1 (2.47) | – | 84.2 (2.49) | 5.14 (1.82) | 1.48 to 8.81 | 0.007 | |
Qol-psychological | 74.7 (2.90) | – | 78.3 (2.92) | 3.61 (1.88) | −0.16 to 7.39 | 0.060 | |
Qol-social | 75.6 (2.82) | – | 80.8 (2.82) | 5.27 (2.55) | 0.14 to 10.4 | 0.044 | |
Qol-environment | 83.5 (2.20) | – | 87.8 (2.22) | 4.31 (1.77) | 0.76 to 7.85 | 0.018 | |
Qol-overall | 77.2 (3.33) | – | 79.2 (3.37) | 1.96 (2.98) | −4.03 to 7.95 | 0.514 | |
FACIT-Sp-12 | 33.6 (1.40) | – | 36.4 (1.42) | 2.74 (1.33) | 0.06 to 5.42 | 0.045 | |
Delayed group ( |
HADS total | 8.69 (1.19) | 10.08 (1.33) | 6.72 (0.96) | −1.97 (0.89) | −3.76 to −0.19 | 0.031 |
PDI | 37.9 (2.52) | – | 34.9 (2.56) | −3.01 (1.69) | −6.41 to 0.39 | 0.081 | |
Qol-physical | 78.3 (2.57) | – | 79.2 (2.61) | 0.88 (1.93) | −3.00 to 4.76 | 0.651 | |
Qol-psychological | 76.0 (3.01) | – | 76.0 (3.06) | 0.01 (1.99) | −3.98 to 4.01 | 0.994 | |
Qol-social | 79.8 (2.90) | – | 79.4 (2.97) | −0.43 (2.66) | −5.76 to 4.91 | 0.873 | |
Qol-environment | 84.3 (2.28) | – | 86.7 (2.33) | 2.44 (1.87) | −1.31 to 6.19 | 0.198 | |
Qol-overall | 70.7 (3.46) | – | 72.9 (3.55) | 2.26 (3.15) | −4.06 to 8.58 | 0.475 | |
FACIT-Sp-12 | 34.5 (1.46) | – | 35.0 (1.50) | 0.44 (1.41) | −2.39 to 3.27 | 0.757 |
To further analyze the effect of the intervention the data from both groups were combined by merging the T2, T3, and T4 assessments of the delayed treatment group with the T0, T1, and T2 assessments of the immediate treatment group. The results are displayed in
Treatment satisfaction and secondary outcomes in the whole sample of patients complemented by a comparison in study partners.
Combined patient sample |
Treatment satisfaction ( |
– | 37.8 (1.00) | 40.4 (0.62) | 2.60 (0.94) | 4.49 to 0.72 | 0.008 |
HADS total | 7.62 (0.74) | 8.74 (0.83) | 6.15 (0.82) | −1.46 (0.70) | −2.84 to −0.08 | 0.039 | |
PDI | 36.9 (1.58) | – | 32.3 (1.61) | −4.63 (1.06) | −6.77 to −2.50 | <0.001 | |
Qol-physical | 78.9 (1.90) | – | 82.2 (1.76) | 3.25 (1.25) | 0.73 to 5.77 | 0.013 | |
Qol-psychological | 75.0 (2.12) | – | 78.9 (1.97) | 3.94 (1.64) | 0.67 to 7.20 | 0.019 | |
Qol-social | 77.0 (1.89) | – | 81.2 (2.15) | 4.11 (1.57) | 0.97 to 7.25 | 0.011 | |
Qol-environment | 84.8 (1.46) | – | 88.8 (1.41) | 3.99 (1.34) | 1.33 to 6.66 | 0.004 | |
Qol-overall | 75.0 (2.43) | – | 78.6 (2.34) | 3.62 (2.25) | −0.85 to 8.09 | 0.111 | |
FACIT-Sp-12 | 34.0 (0.98) | – | 35.8 (1.00) | 1.77 (0.87) | 0.01 to 3.52 | 0.048 | |
Study partners ( |
Treatment satisfaction ( |
– | 36.3 (0.96) | 34.9 (0.97) | −1.38 (0.62) | −2.64 to −0.13 | 0.032 |
HADS total | 9.87 (0.87) | 9.21 (0.89) | 9.69 (0.89) | −0.17 (0.67) | −1.50 to 1.15 | 0.797 | |
Qol-physical | 76.4 (2.07) | – | 75.0 (2.57) | −1.35 (2.08) | −5.54 to 2.84 | 0.519 | |
Qol-psychological | 75.8 (1.66) | – | 75.8 (1.79) | −0.02 (1.63) | −3.26 to 3.23 | 0.991 | |
Qol-social | 75.2 (2.30) | – | 74.5 (2.29) | −0.66 (1.41) | −3.46 to 2.15 | 0.642 | |
Qol-environment | 85.2 (1.38) | – | 84.1 (1.80) | −1.10 (1.52) | −4.13 to 1.93 | 0.470 | |
Qol-overall | 70.9 (2.67) | – | 68.9 (2.56) | −2.03 (2.25) | −6.50 to 2.44 | 0.370 |
We finally tested whether Dignity Therapy had any effects on outcome measures in family members/close friends. As displayed in
Our main finding was that Dignity Therapy, a short psychotherapeutic intervention to enhance the sense of dignity, was feasible and highly accepted in a sample of patients with early stage dementia and in their family members. Despite SARS-Cov2-Pandemic problems (recruiting stop of more than 2 months) we successfully enrolled enough patients over a period of 2 years and the final participation rate of 38.6% of all screened and invited individuals was almost as high as at least expected and comparable to other studies (
Acceptability was high with a drop-out rate of 11.1%, which was significantly lower than expected at worst and also much lower than reported in other psychotherapy studies, ranging between 10 and 70% (
In terms of the secondary outcomes, we found significant improvements between baseline and 3-months follow-up in almost all measures (HADS, PDI, physical, social, and environment domains of quality of life as well as in spiritual well-being) in the immediate treatment group. This effect was confirmed and even stronger after we pooled the treatment data of the two groups. However, this study was not able to demonstrate a significant group by time effect for any of the outcome measures. This finding was not entirely surprising, because this study was not primarily designed to detect such an effect as argued in our power analysis. Further studies with larger sample sizes and enough power are therefore needed. Furthermore, in our study the effect size for HADS scores between the groups was small (Cohen's d = 0.1), which might be explained by a floor effect: the mean HADS totals scores were very low and with no serious evidence for a clinically relevant depression or anxiety disorder. In the absence of such clinical symptoms, there is little room for improvement. Future studies, therefore, should consider screenings for psychological distress before enrollment to improve the likelihood of detecting differences.
In this study we also invited family members or close friends to accompany the patients during the intervention. The main reason for this setting was that family members or close friends who are known to be distressed by the diagnosis of dementia (
This is the first randomized, waitlist controlled study to determine feasibility, acceptability, and potential efficacy of Dignity Therapy in patients with early stage dementia and their family members. The present trial showed that Dignity Therapy was feasible, highly accepted and potential effective. However, because of the primary aim of the study and the accordingly study design this study was underpowered to demonstrate significant differences between the immediate and delayed treatment group in the RCT condition. Further research with larger samples and probably inclusion of only pre-screened patients with moderate psychological distress is needed to better ascertain the efficacy of this intervention among patients with early stage dementia. This study has some other limitations. It had a short-term follow-up and as a potential selection bias included patients and study partners with very low psychological burden. The included study partners were rather heterogeneous and future studies need to examine whether feasibility and acceptance varies among different caregiver constellations. Further, according to the study design using a waiting list control instead of a control group without intervention, there might have been an optimistic expectation in waiting list participants too. Another limitation is that we did not assess fidelity of the intervention systematically, for instance, by analyzing the audio-taped interviews or the transcribed generativity documents. However, all therapists were thoroughly trained and regularly supervised by the study coordinator and first author. Finally, the study coordinator who was responsible for the assessments was not blinded for the randomization. However, in this trial we used exclusively self-report instruments which reduces the probability of a potential detection bias (
Results of this randomized clinical trial demonstrated the feasibility, acceptability, and potential efficacy of Dignity Therapy among patients with early stage dementia. Dignity Therapy might be a promising intervention to enhance dignity among those patients and their family members or close friends. It, therefore, might have the potential to close an existing gap in the holistic treatment of dementia. Further studies are needed in larger and more distressed populations.
The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.
The studies involving human participants were reviewed and approved by Cantonal Ethics Committee of Zurich (BASEC-Nr.2018-01097). The patients/participants provided their written informed consent to participate in this study.
JJ, HM, PM, TM-H, and SP-K were responsible for the study conception and design. JJ and HM drafted the manuscript. All authors contributed to the acquisition, analysis, or interpretation of data and also provided a critical review, approved the final manuscript and had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analyses. JJ attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.
This work was supported by Porticus (KRS-144045; PCG-155468).
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
The Supplementary Material for this article can be found online at: