Use of a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention in a Community Population of Adults With Depression Symptoms: Randomized Controlled Trial (Preprint)

BACKGROUND Although internet-based cognitive behavior therapy (iCBT) interventions can reduce depression symptoms, large differences in their effectiveness exist. OBJECTIVE The aim of this study was to evaluate the effectiveness of an iCBT intervention called Thrive, which was designed to enhance engagement when delivered as a fully automated, stand-alone intervention to a rural community population of adults with depression symptoms. METHODS Using no diagnostic or treatment exclusions, 343 adults with depression symptoms were recruited from communities using an open-access website and randomized 1:1 to the Thrive intervention group or the control group. Using self-reports, participants were evaluated at baseline and 4 and 8 weeks for the primary outcome of depression symptom severity and secondary outcome measures of anxiety symptoms, work and social adjustment, psychological resilience, and suicidal ideation. RESULTS Over the 8-week follow-up period, the intervention group (n=181) had significantly lower depression symptom severity than the control group (n=162; <italic>P</italic><.001), with a moderate treatment effect size (<italic>d</italic>=0.63). Moderate to near-moderate effect sizes favoring the intervention group were observed for anxiety symptoms (<italic>P</italic><.001; <italic>d</italic>=0.47), work/social functioning (<italic>P</italic><.001; <italic>d</italic>=0.39), and resilience (<italic>P</italic><.001; <italic>d</italic>=0.55). Although not significant, the intervention group was 45% less likely than the control group to experience increased suicidal ideation (odds ratio 0.55). CONCLUSIONS These findings suggest that the Thrive intervention was effective in reducing depression and anxiety symptom severity and improving functioning and resilience among a mostly rural community population of US adults. The effect sizes associated with Thrive were generally larger than those of other iCBT interventions delivered as a fully automated, stand-alone intervention. CLINICALTRIAL ClinicalTrials.gov NCT03244878; https://clinicaltrials.gov/ct2/show/NCT03244878

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Use of a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention in a Community Population of Adults With Depression Symptoms: Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/14754 ◽

2019 ◽

Vol 21 (11) ◽

pp. e14754 ◽

Cited By ~ 4

Author(s):

Mark B Schure ◽

Janet C Lindow ◽

John H Greist ◽

Paul A Nakonezny ◽

Sandra J Bailey ◽

...

Keyword(s):

Suicidal Ideation ◽

Rural Community ◽

Symptom Severity ◽

Intervention Group ◽

Effect Sizes ◽

Control Group ◽

Depression Symptoms ◽

Depression Symptom ◽

Cognitive Behavior ◽

Community Population

Background Although internet-based cognitive behavior therapy (iCBT) interventions can reduce depression symptoms, large differences in their effectiveness exist. Objective The aim of this study was to evaluate the effectiveness of an iCBT intervention called Thrive, which was designed to enhance engagement when delivered as a fully automated, stand-alone intervention to a rural community population of adults with depression symptoms. Methods Using no diagnostic or treatment exclusions, 343 adults with depression symptoms were recruited from communities using an open-access website and randomized 1:1 to the Thrive intervention group or the control group. Using self-reports, participants were evaluated at baseline and 4 and 8 weeks for the primary outcome of depression symptom severity and secondary outcome measures of anxiety symptoms, work and social adjustment, psychological resilience, and suicidal ideation. Results Over the 8-week follow-up period, the intervention group (n=181) had significantly lower depression symptom severity than the control group (n=162; P<.001), with a moderate treatment effect size (d=0.63). Moderate to near-moderate effect sizes favoring the intervention group were observed for anxiety symptoms (P<.001; d=0.47), work/social functioning (P<.001; d=0.39), and resilience (P<.001; d=0.55). Although not significant, the intervention group was 45% less likely than the control group to experience increased suicidal ideation (odds ratio 0.55). Conclusions These findings suggest that the Thrive intervention was effective in reducing depression and anxiety symptom severity and improving functioning and resilience among a mostly rural community population of US adults. The effect sizes associated with Thrive were generally larger than those of other iCBT interventions delivered as a fully automated, stand-alone intervention. Trial Registration ClinicalTrials.gov NCT03244878; https://clinicaltrials.gov/ct2/show/NCT03244878

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Twelve-Month Follow-Up to a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention for Rural Adults With Depression Symptoms: Single-Arm Longitudinal Study

Journal of Medical Internet Research ◽

10.2196/21336 ◽

2020 ◽

Vol 22 (10) ◽

pp. e21336 ◽

Cited By ~ 1

Author(s):

Mark Schure ◽

Bernadette McCrory ◽

Kathryn Tuchscherer Franklin ◽

John Greist ◽

Ruth Striegel Weissman

Keyword(s):

Suicidal Ideation ◽

Outcome Measures ◽

Behavior Therapy ◽

Cognitive Behavior Therapy ◽

Symptom Severity ◽

The United States ◽

Secondary Outcome ◽

Depression Symptoms ◽

Cognitive Behavior ◽

Program Adherence

Background Internet-based cognitive behavior therapy (iCBT) interventions have the potential to help individuals with depression, regardless of time and location. Yet, limited information exists on the longer-term (>6 months) effects of iCBT and adherence to these interventions. Objective The primary aim of this study was to evaluate the longitudinal (12 months) effectiveness of a fully automated, self-guided iCBT intervention called Thrive, designed to enhance engagement with a rural population of adults with depression symptoms. The secondary aim was to determine whether the program adherence enhanced the effectiveness of the Thrive intervention. Methods We analyzed data from 181 adults who used the Thrive intervention. Using self-reports, participants were evaluated at baseline, 8 weeks, 6 months, and 12 months for the primary outcome of depression symptom severity using the Patient Health Questionnaire-9 (PHQ-9) scale and secondary outcome measures, namely, the Generalized Anxiety Disorder Scale-7 (GAD-7) scores, Work and Social Adjustment Scale (WSAS) scores, Conner-Davidson Resilience Scale-10 (CD-RISC-10) scores, and suicidal ideation (ninth item of the PHQ-9 scale) scores. The Thrive program adherence was measured using the numbers of program logins, page views, and lessons completed. Results The assessment response rates for 8-week, 6-month, and 12-month outcomes were 58.6% (106/181), 50.3% (91/181), and 51.4% (93/181), respectively. By 8 weeks, significant improvements were observed for all outcome measures. These improvements were maintained at 12 months with mean reductions in severities of depression (mean –6.5; P<.001) and anxiety symptoms (mean –4.3; P<.001). Improvements were also observed in work and social functioning (mean –6.9; P<.001) and resilience (mean 4.3; P<.001). Marked decreases were observed in suicidal ideation (PHQ-9 ninth item score >1) at 6 months (16.5%) and 12 months (17.2%) compared to baseline (39.8%) (P<.001). In regard to the program adherence, cumulative counts of page views and lessons completed were significantly related to lower PHQ-9, GAD-7, and WSAS scores and higher CD-RISC-10 scores (all P values <.001 with an exception of page views with WSAS for which P value was .02). Conclusions The Thrive intervention was effective at reducing depression and anxiety symptom severity and improving functioning and resilience among a population of adults from mostly rural communities in the United States. These gains were maintained at 1 year. Program adherence, measured by the number of logins and lessons completed, indicates that users who engage more with the program benefit more from the intervention. Trial Registration ClinicalTrials.gov NCT03244878; https://clinicaltrials.gov/ct2/show/NCT03244878

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Twelve-Month Follow-Up to a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention for Rural Adults With Depression Symptoms: Single-Arm Longitudinal Study (Preprint)

10.2196/preprints.21336 ◽

2020 ◽

Author(s):

Mark Schure ◽

Bernadette McCrory ◽

Kathryn Tuchscherer Franklin ◽

John Greist ◽

Ruth Striegel Weissman

Keyword(s):

Suicidal Ideation ◽

Outcome Measures ◽

Behavior Therapy ◽

Cognitive Behavior Therapy ◽

Symptom Severity ◽

The United States ◽

Secondary Outcome ◽

Depression Symptoms ◽

Cognitive Behavior ◽

Program Adherence

BACKGROUND Internet-based cognitive behavior therapy (iCBT) interventions have the potential to help individuals with depression, regardless of time and location. Yet, limited information exists on the longer-term (>6 months) effects of iCBT and adherence to these interventions. OBJECTIVE The primary aim of this study was to evaluate the longitudinal (12 months) effectiveness of a fully automated, self-guided iCBT intervention called Thrive, designed to enhance engagement with a rural population of adults with depression symptoms. The secondary aim was to determine whether the program adherence enhanced the effectiveness of the Thrive intervention. METHODS We analyzed data from 181 adults who used the Thrive intervention. Using self-reports, participants were evaluated at baseline, 8 weeks, 6 months, and 12 months for the primary outcome of depression symptom severity using the Patient Health Questionnaire-9 (PHQ-9) scale and secondary outcome measures, namely, the Generalized Anxiety Disorder Scale-7 (GAD-7) scores, Work and Social Adjustment Scale (WSAS) scores, Conner-Davidson Resilience Scale-10 (CD-RISC-10) scores, and suicidal ideation (ninth item of the PHQ-9 scale) scores. The Thrive program adherence was measured using the numbers of program logins, page views, and lessons completed. RESULTS The assessment response rates for 8-week, 6-month, and 12-month outcomes were 58.6% (106/181), 50.3% (91/181), and 51.4% (93/181), respectively. By 8 weeks, significant improvements were observed for all outcome measures. These improvements were maintained at 12 months with mean reductions in severities of depression (mean –6.5; P<.001) and anxiety symptoms (mean –4.3; P<.001). Improvements were also observed in work and social functioning (mean –6.9; P<.001) and resilience (mean 4.3; P<.001). Marked decreases were observed in suicidal ideation (PHQ-9 ninth item score >1) at 6 months (16.5%) and 12 months (17.2%) compared to baseline (39.8%) (P<.001). In regard to the program adherence, cumulative counts of page views and lessons completed were significantly related to lower PHQ-9, GAD-7, and WSAS scores and higher CD-RISC-10 scores (all P values <.001 with an exception of page views with WSAS for which P value was .02). CONCLUSIONS The Thrive intervention was effective at reducing depression and anxiety symptom severity and improving functioning and resilience among a population of adults from mostly rural communities in the United States. These gains were maintained at 1 year. Program adherence, measured by the number of logins and lessons completed, indicates that users who engage more with the program benefit more from the intervention. CLINICALTRIAL ClinicalTrials.gov NCT03244878; https://clinicaltrials.gov/ct2/show/NCT03244878

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The characteristics of anxiety and depression symptom severity in older adults living in public housing

International Psychogeriatrics ◽

10.1017/s1041610211001979 ◽

2011 ◽

Vol 24 (4) ◽

pp. 614-623 ◽

Cited By ~ 7

Author(s):

Adam Simning ◽

Yeates Conwell ◽

Susan G. Fisher ◽

Thomas M. Richardson ◽

Edwin van Wijngaarden

Keyword(s):

Public Housing ◽

Older Adult ◽

Symptom Severity ◽

Regression Models ◽

Late Life ◽

Anxiety And Depression ◽

Depression Symptoms ◽

Depression Symptom ◽

The Social ◽

Public Housing Residents

ABSTRACTBackground:Anxiety and depression are common in older adult public housing residents and frequently co-occur. To understand anxiety and depression more fully in this socioeconomically disadvantaged population, this study relies on the Social Antecedent Model of Psychopathology to characterize anxiety and depression symptoms concurrently.Methods:190 public housing residents aged 60 years and older in Rochester, New York, participated in a research interview during which they reported on variables across the six stages of the Social Antecedent Model. GAD-7 and PHQ-9 assessed anxiety and depression symptoms, respectively.Results:In these older adult residents, anxiety and depression symptom severity scores were correlated (r = 0.61; p < 0.001). Correlates of anxiety and depression symptom severity were similar for both outcomes and spanned the six stages of the Social Antecedent Model. Multivariate linear regression models identified age, medical comorbidity, mobility, social support, maladaptive coping, and recent life events severity as statistically significant correlates. The regression models accounted for 43% of anxiety and 48% of depression symptom variability.Conclusions:In public housing residents, late-life anxiety and depression symptoms were moderately correlated. Anxiety symptom severity correlates were largely consistent with those found for depression symptom severity. The broad distribution of correlates across demographic, social, medical, and behavioral domains suggests that the context of late-life anxiety and depression symptomatology in public housing is complex and that multidisciplinary collaborative care approaches may be warranted in future interventions.

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Suicidal Ideation Amongst Adolescent Suffering from Disordered Eating: The Young-HUNT Study

European Psychiatry ◽

10.1016/j.eurpsy.2017.01.278 ◽

2017 ◽

Vol 41 (S1) ◽

pp. S88-S89

Author(s):

F. Saeedzadeh Sardahaee ◽

T. Lingaas Holmen ◽

N. Micali ◽

K. Kvaløy

Keyword(s):

Suicidal Ideation ◽

Disordered Eating ◽

Odds Ratio ◽

Associated Factors ◽

Preventive Measures ◽

Eating Attitude ◽

Control Group ◽

Case Group ◽

Depression Symptoms ◽

Poor Appetite

IntroductionSuicide takes a great toll on both individuals and societies. Successful preventive measures would require a careful understanding of the scope of suicidal ideation as well as its associated factors. Amongst mental disorders, anorexia nervosa has the highest mortality rate due to suicide.Objective and aimsStudying the prevalence of suicidal ideation and its associated factors in adolescents (13–19 years old) affected by disordered eating (DE).MethodsLogistic regression was employed to study associations between suicidal ideation and age, gender and disordered eating in adolescents from a population-based prospective study, The Young-HUNT 3 cohort, 2006-8. DE cases were defined using the self-reported questionnaire (Eating Attitude Test-7) and then grouped into two subscales, poor appetite/under-eating and uncontrolled appetite/overeating.ResultsA total of 3933(boys 49% and 51% girls) were included. In total, 177 poor appetite/under-eating and 365 uncontrolled appetite/overeating cases were identified. Prevalence of suicidal ideation was 24.5% in total sample with girls being more affected (27.1%). Prevalence of suicidal ideation amongst poor appetite/under-eating case group and uncontrolled appetite/overeating cases was respectively 43.5 and 39.2%. The odds-ratio of suicidal ideation amongst poor appetite/under-eating cases compared to control group was 2.56 (95% CI, 1.85 to 3.42, P-value < 0.001) whilst the odds-ratio of suicidal ideation amongst uncontrolled appetite/overeating cases compared to control group was 2.19 (95% CI, 1.75 to 2.74, P-value < 0.001). Results remained significant after adjusting for anxiety and depression symptoms.ConclusionFocus on high risk groups such as DE seems important in taking suicide preventive measures.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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Depression among patients with diabetes mellitus in a Nigerian teaching hospital

South African Journal of Psychiatry ◽

10.4102/sajpsychiatry.v16i2.232 ◽

2010 ◽

Vol 16 (2) ◽

pp. 4 ◽

Cited By ~ 3

Author(s):

Bawo Onesirosan James ◽

Joyce Ohiole Omoaregba ◽

George Eze ◽

Olufemi Morakinyo

Keyword(s):

Diabetes Mellitus ◽

Control Group ◽

Depression Symptoms ◽

Depression Symptom ◽

Treatment Goals ◽

Cross Sectional Survey ◽

Cross Sectional ◽

Prevalence Of Depression ◽

Patients With Diabetes ◽

Diabetes Patients

Objectives. Depression is associated with diabetes mellitus and affects treatment goals negatively. We aimed to determine the prevalence of depression and identify its socio-demographic or clinical correlates among patients with diabetes mellitus attending an out-patient clinic in Nigeria.Methods. Two hundred consecutively recruited diabetes patients (index group) were compared with a similar number of apparently healthy controls in a cross-sectional survey. In both groups, in addition to obtaining socio-demographic details, depression was diagnosed using the Schedule for the Clinical Assessment in Neuropsychiatry (SCAN), while the Beck Depression Inventory (BDI) was used to assess depression symptom severity. Results. Sixty (30%) diabetes patients met a SCAN diagnosis for clinical depression, compared with 19 (9.5%) in the control group. Having a smaller income and more children were significantly correlated with higher depression symptoms on the BDI.Conclusion. Depression is highly co-morbid with diabetes mellitus. The care of individuals with diabetes mellitus should include the screening and possible treatment for depression in order to achieve and sustain treatment goals.

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Effectiveness of mobile short messaging services to improve parent’s knowledge, attitude and practice on drowning prevention in Bangladesh (Preprint)

10.2196/preprints.27829 ◽

2021 ◽

Author(s):

Prof Dr Kulanthayan KC Mani ◽

Dr Md Mosharaf Hossain

Keyword(s):

Rural Community ◽

Intervention Group ◽

Developed Countries ◽

Control Group ◽

Drowning Prevention ◽

Under Five ◽

Time Interaction ◽

Sms Intervention ◽

Outcome Differences ◽

Cluster Randomized

BACKGROUND Drowning is the leading cause of death in children aged one year and over in Bangladesh. Drowning rates in Bangladesh are 10 to 20 times the rates of child drowning in developed countries. OBJECTIVE The aim of this to test the effectiveness of a mobile SMS intervention to improve the knowledge, attitude, and practices of parents of children aged under five concerning the prevention of drowning. METHODS Study Design: a cluster randomized community trial with 788 parents of children aged under five in a rural community of Bangladesh. Methods: Intervention: Mobile SMS intervention for parents of children under five years concerning the prevention of drowning. Outcome: differences in knowledge, attitude and practices of parents concerning the prevention of drowning between the baseline and immediate follow-up after the intervention, and after three months. RESULTS There was a significant improvement in knowledge in the intervention group compared to the control group at different time points [baseline: F(1, 787) = 0.33, ρ-value = 0.56; immediately after intervention: F(1, 772) = 2989.25, ρ-value = 0.001; 3-months after intervention F(1, 761) = 4591.33, ρ-value = 0.001]. Similarly, there was an improvement in the positive attitude and good practices of parents on prevention of drowning. There were significant main effect for group [F(1, 379) = 5084.81, ρ-value = 0.001], time [F(1, 379) = 5786.11, ρ-value = 0.001], and group and time interaction [F(1, 331) = 2425.33, ρ-value = 0.001] in terms of the drowning prevention knowledge of parents. Similarly, the main effects for group, time, and group and time interaction for drowning prevention attitude and drowning prevention practices of parents were also significant. CONCLUSIONS The mobile based SMS intervention developed was effective in improving the knowledge, attitude, and practices of parents of children aged under five concerning drowning prevention in a rural community of Bangladesh. CLINICALTRIAL ISRCTN13774693

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Psychological and physiological effects of emotion focused training for self-compassion and self-protection

Research in Psychotherapy Psychopathology Process and Outcome ◽

10.4081/ripppo.2019.358 ◽

2019 ◽

Vol 22 (2) ◽

Cited By ~ 1

Author(s):

Júlia Halamová ◽

Jana Koróniová ◽

Martin Kanovský ◽

Mária Kénesy Túniyová ◽

Nuriye Kupeli

Keyword(s):

Heart Rate ◽

Heart Rate Variability ◽

Active Control ◽

Expressive Writing ◽

Intervention Group ◽

Effect Sizes ◽

Control Group ◽

Active Control Group ◽

Self Compassion ◽

Self Protection

Emotion Focused Training for Self-Compassion and Self-Protection (EFT-SCP) is a novel intervention developed on the basis of the latest findings on self-criticism from Emotion-focused therapy and existing programs designed to cultivate compassion. EFT-SCP is designed to encourage participants to cultivate self-compassion and protective anger as a way of reducing selfcriticism. Our goal was to investigate the effect of this group-based intervention on self-criticism, self-protection, and self-compassion. A total of 73 students were assigned to the EFT-SCP intervention (n=19), no-treatment control (n=34) or to an active control group (n=20). The intervention group met weekly for 1.5 hours and were instructed to incorporate EFT-SCP tasks into their daily life for 12 weeks. Whilst the no-treatment group did not undergo an intervention, the active control group completed an adapted expressive writing task once a week. In addition to the assessment of heart rate variability during imagery tasks, participants also completed self-reported measures of self-compassion and self-criticism before and after the intervention. Compared with both control groups, the intervention group showed a significant increase in heart rate variability following EFT-SCP (during self-critical imagery, P=.049; probability of superiority was .63, and during self-compassionate imagery P=.007; probability of superiority was .62, both effect sizes were medium) and significant decreases in self-criticism (Hated Self P=.017; .34 and Inadequate Self P<.001; .33) and selfuncompassionate responding (P<.001; .39). All three effect sizes were small. Participating in EFT-SCP had a positive effect on psychological and physiological outcomes.

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The effect of group exercises on balance, mobility, and depressive symptoms in older adults with mild cognitive impairment: a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215518815218 ◽

2018 ◽

Vol 33 (3) ◽

pp. 439-449 ◽

Cited By ~ 4

Author(s):

Chandra da Silveira Langoni ◽

Thais de Lima Resende ◽

Andressa Bombardi Barcellos ◽

Betina Cecchele ◽

Juliana Nunes da Rosa ◽

...

Keyword(s):

Older Adults ◽

Cognitive Impairment ◽

Depressive Symptoms ◽

Mild Cognitive Impairment ◽

Intervention Group ◽

Depression Scale ◽

Community Dwelling ◽

Effect Sizes ◽

Control Group ◽

Community Dwelling Older Adults

Objective: To determine the effects of group exercises on balance, mobility, and depressive symptoms in community-dwelling older adults with mild cognitive impairment. Design: Single blinded, randomized, matched pairs clinical trial. Setting: Four primary healthcare units. Subjects: Fifty-two sedentary subjects with mild cognitive impairment were paired (age, sex, body mass index, and Addenbrooke’s Cognitive Examination Revised score), tested, and then randomized into an intervention group ( n = 26) and a control group ( n = 26). Intervention: The intervention group performed strength (ankle weights, elastic bands, and dumbbells) and aerobic exercises (walking) in their communities’ public spaces, twice a week (60 minutes each), during 24 weeks. The control group maintained its usual routine. Main measures: Balance (Berg Balance Scale (BBS)), mobility (Timed Up and Go Test (TUG)), and depressive symptoms (Geriatric Depression Scale-15) were assessed before and after the intervention. Results: Before the intervention, the two groups did not differ statistically. After, the intervention group showed significant improvement ( P < 0.05) in balance (before: 53 ± 3; after: 55.1 ± 1.1 points), mobility (before: 10.7 ± 2.9 seconds; after: 8.3 ± 2 seconds), and depressive symptoms (median punctuation (interquartile range) before: 4 (1.8–6); after: 2.5 (1–4)). The control group presented a significant increase in their depressive symptoms (median before: 3.5 (2–7.3); after: 4 (2–5.3)), while their balance and mobility showed no significant modification. Small effect sizes were observed in the intervention group and control group depressive symptoms, as well as in the control group’s mobility and balance. Large effect sizes were observed the intervention group’s mobility and balance. Conclusion: Group exercises improved balance, mobility, and depressive symptoms in community-dwelling older adults with mild cognitive impairment.

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Impact of Interventions by a Community Pharmacist on Care Burden for People with Dementia: Development and Randomised Feasibility Trial of an Intervention Protocol

10.21203/rs.3.rs-917446/v1 ◽

2021 ◽

Author(s):

Yoko Nanaumi ◽

Atsushi Yoshitani ◽

Mitsuko Onda

Keyword(s):

Community Pharmacist ◽

Intervention Group ◽

Small Sample ◽

Effect Sizes ◽

Feasibility Trial ◽

Control Group ◽

Care Burden ◽

People With Dementia ◽

Intervention Protocol ◽

The Impact

Abstract Background: Traditionally, the role of pharmacists has been to manage and monitor pharmacotherapy for patients with dementia. However, additional intervention by community pharmacists to collect and share patient information with other professionals may help reduce the care burden among caregivers. This study examined the impact of interventions by a community pharmacist, based on active information gathering from other professionals for people with dementia, on the caregivers’ burden of care.Methods: This was a randomised, open-label, parallel-group feasibility study, involving eight Nara City pharmaceutical association member pharmacies that provided consent to participate. These pharmacies were assigned to an intervention group or control group at a 1:1 ratio. The subjects were patients with dementia and their primary caregivers that visited the participating pharmacies and provided consent to participate. Pharmacists in the intervention group actively collected information from the patients’ family physicians and care managers and intervened to address medication-related problems, while those in the control group only performed their normal duties. The primary endpoint was a change in the caregiver’s score on the Japanese version of Zarit Caregiver Burden Interview (J-ZBI) from the baseline to after 5 months of follow-up. The changes in mean J-ZBI scores from the beginning to the end of the study period of the two groups were compared using Welch's t-test, and effect sizes were calculated. The level of significance was set at 5%.Results: Totally, nine patients and nine caregivers in the intervention group, and nine patients and eight caregivers in the control group completed the study. The changes in J-ZBI scores could be calculated for seven cases in the intervention group and five cases in the control group. The J-ZBI scores were found to decrease by 1.0 in the intervention group and increase by 3.0 in the control group (p = 0.075, effect size = 1.414).Conclusions: Although the differences in J-ZBI scores were not statistically significant between the two groups, owing to the small sample sizes, the effect sizes suggest that community pharmacist interventions for people with dementia may reduce the care burden for caregivers.Trial registration: Registration: UMIN000039949 (registration date: 4.1.2020, retrospectively registered)

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