More insight into the concept of apathy: a multidisciplinary depression management program has different effects on depressive symptoms and apathy in nursing homes

2013 ◽  
Vol 25 (12) ◽  
pp. 1941-1952 ◽  
Author(s):  
Ruslan Leontjevas ◽  
Steven Teerenstra ◽  
Martin Smalbrugge ◽  
Myrra J.F.J. Vernooij-Dassen ◽  
Ernst T. Bohlmeijer ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Controlled Trial ◽  
Multidisciplinary Treatment ◽  
Depressive Mood ◽  
Management Program ◽  
Intention To Treat ◽  
Mood Symptoms ◽  
Cohen’S D ◽  
Depression Management ◽  
Cohen's D

ABSTRACTBackground:Apathy is common in nursing home (NH) residents and it overlaps with depression. This study examines the effects of a multidisciplinary depression program on apathy and depressive motivational and mood symptoms.Methods:Secondary analyses of a stepped-wedge cluster-randomized controlled trial were conducted with six measurements. Sixteen dementia NH units and 17 somatic units were enrolled. In the intervention condition, a program containing depression assessment procedures and multidisciplinary treatment (activating strategies, psychotherapy, and medication) was introduced. Usual care was provided in the control condition. Outcomes were assessed using the 10-item Apathy Evaluation Scale and the Cornell Scale for Depression in Dementia.Results:Intention-to-treat analyses showed that the whole depression management program reduced apathy in dementia units (p < 0.001; Cohen's d, −0.35), and depressive motivational symptoms in somatic units (p = 0.008; Cohen's d, −0.40). Depressive mood symptoms were not affected in both unit types. The effect on apathy in dementia units was mainly attributed to activating strategies (p < 0.001; Cohen's d, −0.73). The effect on motivational symptoms in somatic units was mainly attributed to psychotherapy (p = 0.002; Cohen's d, −0.80). Apathy worsening was associated with pharmacological depression treatment in both unit types (p = 0.009; Cohen's d, 0.35).Conclusions:Depression management may affect apathy and depressive symptoms differently, which underpins the position of apathy as a distinct syndrome. NH professionals can effectively use activating strategies in dementia units, and psychotherapy in somatic units. More research is needed on treating depressive mood symptoms, and on effects of antidepressants in NHs.

scholarly journals Involving clinical experts in prioritising topics for health technology assessment: a randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e016104 ◽  
Author(s):  
Andrew Cook ◽  
Elke Streit ◽  
Gill Davage
Keyword(s):  
Controlled Trial ◽  
Free Text ◽  
Intention To Treat ◽  
Cohen’S D ◽  
Registration Number ◽  
Review Form ◽  
Response Modes ◽  
Randomised Controlled ◽  
Scoring Tool ◽  
Cohen's D

ObjectivesThe objective of this study was to explore whether reducing the material supplied to external experts during peer review and decreasing the burden of response would maintain review quality into prioritising research questions for a major research funder.Methods and analysisClinical experts who agreed to review documents outlining research for potential commissioning were screened for eligibility and randomised in a factorial design to two types of review materials (long document versus short document) and response modes (structured review form versus free text email response). Previous and current members of the funder’s programme groups were excluded. Response quality was assessed by use of a four-point scoring tool and analysed by intention to treat.Results554 consecutive experts were screened for eligibility and 460 were randomised (232 and 228 to long document or short document, respectively; 230 each to structured response or free text). 356 participants provided reviews, 90 did not respond and 14 were excluded after randomisation as not eligible.The pooled mean quality score was 2.4 (SD=0.95). The short document scored 0.037 (Cohen’s d=0.039) extra quality points over the long document arm, and the structured response scored 0.335 (Cohen’s d=0.353) over free text. The allocation did not appear to have any effect on the experts' willingness to engage with the task.ConclusionsNeither providing a short or a long document outlining suggested research was shown to be superior. However, providing a structured form to guide the expert response provided more useful information than allowing free text. The funder should continue to use a structured form to gather responses. It would be acceptable to provide shorter documents to reviewers, if there were reasons to do so.Trial registration numberANZCTR12614000167662.

Zao Ren An Shen capsule for insomnia: A double-blind, randomized, placebo-controlled trial

SLEEP ◽  
2021 ◽  
Author(s):  
Yoann Birling ◽  
Xiaoshu Zhu ◽  
Nicole Avard ◽  
Caterina Tannous ◽  
Paul P Fahey ◽  
...  
Keyword(s):  
Herbal Medicine ◽  
Adverse Events ◽  
Chinese Herbal Medicine ◽  
Controlled Trial ◽  
Double Blind ◽  
Subjective Sleep ◽  
Chinese Herbal ◽  
Cohen’S D ◽  
Cohen's D ◽  
Insomnia Severity

Abstract Study Objectives The aim of this study was to test the efficacy and safety of Zao Ren An Shen (ZRAS) capsule, a Chinese herbal medicine product, for the treatment of insomnia. Methods We conducted a double-blind randomized placebo-controlled trial. After a one-week placebo run-in, a total of 85 people with insomnia were randomly allocated to receive ZRAS or placebo for four weeks. The primary outcomes were insomnia severity assessed with the Insomnia Severity Index (ISI) and the number of participants with adverse events. Secondary outcomes included objective and subjective sleep parameters, psychological status, fatigue level, quality of life, acceptability, and tolerability. Results A non-significant (p &gt; 0.05) difference of 0.7 points in ISI in favor of ZRAS capsule was found at the end of the treatment. The number of participants with adverse events was not significantly different (p &gt; 0.05) between the two groups. Except for subjective sleep onset latency, which had a non-significant (p &gt; 0.05) medium effect (Cohen’s d = 0.5), the effects in secondary efficacy outcomes were all small (Cohen’s d &lt; 0.4) and non-significant (p &gt; 0.05). The acceptability and tolerability were high in the active group. Conclusions ZRAS capsule is safe, acceptable, and tolerable, yet not more effective than placebo in the treatment of insomnia. As previous evidence showed that Chinese herbal medicine was effective for insomnia, these results may be explained by the dose of the product, which was lower than the dose generally used in the clinic.

Is Three a Crowd? The Influence of Companions on a Patient’s Decision to Transition to a Biosimilar

2021 ◽  
Author(s):  
Chiara Gasteiger ◽  
Katie M Groom ◽  
Maria Lobo ◽  
Urte Scholz ◽  
Nicola Dalbeth ◽  
...  
Keyword(s):  
Risk Perceptions ◽  
Controlled Trial ◽  
Decisional Conflict ◽  
Clinical Trial Registry ◽  
Additional Time ◽  
Support Person ◽  
Cohen’S D ◽  
Practical Support ◽  
Cohen's D ◽  
To Receive

Abstract Background Involving patients in treatment decisions is commonplace in healthcare, and patients are frequently accompanied by a companion (support person). Companions are often actively involved in medical consultations, yet their impact on decisions to change medications is unknown. Purpose This study examines the influence of companions on a patient’s decision to transition from their bio-originator therapy to a biosimilar. Methods A parallel, two-arm randomized controlled trial was conducted with 79 patients taking a bio-originator for rheumatic diseases who regularly attend clinic with a companion. Patients were randomized to receive an explanation about a hypothetical transition to a biosimilar alone or with their companion. Patients reported willingness to transition, risk perceptions, difficulty understanding, social support, and completed the Decisional Conflict Scale and Satisfaction with Decision Scale. Results Companions did not influence decisions to transition to biosimilars or cognitive and affective risk perceptions. Accompanied patients reported more difficulty understanding the explanation (p = .006, Cohen’s d = .64) but thought it was more important to receive information with companions (p = .023, Cohen’s d = −.52). Companions did not impact decision satisfaction or decisional conflict. Receiving emotional, but not practical support, was associated with less decisional conflict in accompanied patients (p = .038, r  2 = 0.20). Conclusions The presence of companions does not seem to influence risk perceptions or decisions about transitioning to biosimilars. Companions, however, impact the patient’s reporting of their ability to understand treatment explanations. Providers should check understanding in all patients but may need to provide additional time or educational resources to accompanied patients and companions. Trial registration Australian New Zealand Clinical Trial Registry: ACTRN12619001435178.

scholarly journals Predictors of Health Self-Management Program Preference Among Lower-to-Middle Wage Employed Adults With Chronic Health Conditions

2019 ◽  
Vol 33 (2) ◽  
pp. 172-182
Author(s):  
Shawn M. Kneipp ◽  
Lindsey Horrell ◽  
Ziya Gizlice ◽  
Matthew Lee Smith ◽  
Laura Linnan ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Chronic Disease ◽  
Disease Burden ◽  
Multinomial Logistic Regression ◽  
Controlled Trial ◽  
Management Program ◽  
Financial Strain ◽  
Self Management ◽  
Cross Sectional ◽  
Chronic Disease Burden

Purpose: We examined the extent to which demographic, chronic disease burden, and financial strain characteristics were associated with a preference for engaging in the Chronic Disease Self-Management Program (presented as a “health self-management program” [HSMP]) over a financial self-management program (FSMP) and a no program preference (NPP) group among employed adults. Design: Cross-sectional, correlation design using baseline data from a randomized controlled trial (RCT). Subjects: The analytic sample included 324 workers aged 40 to 64 years with 1 or more chronic disease conditions recruited into the RCT from 2015 to 2017. Measures: Chronic disease burden measures included the number of chronic conditions, body mass index (BMI), and the 8-item and 15-item Patient Health Questionnaire (PHQ-8 and PHQ-15). Financial strain was measured as the inability to purchase essentials and food assistance receipt. Both individual and household measures of income were assessed. Analyses: Multinomial logistic regression and post-hoc marginal effects models. Results: Moderate-to-severe depressive symptoms increased the likelihood of having an HSMP preference when compared with those preferring the FSMP (RR = 4.2, P < .05) but not those having NPP; while higher BMI marginally increased HSMP preference over FSMP preference, but not NPP groups (RR = 1.04, P < .05). Financial strain differentially, but significantly, reduces the likelihood of HSMP preference at varying levels of household poverty, depressive symptom severity, and financial strain. Conclusion: Middle-aged, lower-to-middle income workers with moderate-to-severe depressive symptoms opt for HSMPs over FSMPs, but preference for HSMPs significantly diminished when they are experiencing financial strain.

scholarly journals Internet-based treatment for depression in multiple sclerosis: A randomized controlled trial

2016 ◽  
Vol 23 (8) ◽  
pp. 1112-1122 ◽  
Author(s):  
Rosa E Boeschoten ◽  
Joost Dekker ◽  
Bernard MJ Uitdehaag ◽  
Aartjan TF Beekman ◽  
Adriaan W Hoogendoorn ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
Severe Depression ◽  
Wait List ◽  
Wait List Control ◽  
Face To Face ◽  
Intention To Treat ◽  
Promising Tool ◽  
Sum Score

Background: Depression in multiple sclerosis (MS) patients is common but may stay untreated. Physical limitations impede face-to-face treatment. Internet-based treatment is therefore a promising tool for treating depression in MS. Objectives: To investigate effectiveness of a guided Internet-based problem-solving treatment (IPST) for depressed MS patients. Methods: MS patients with moderate or severe depressive symptoms were randomly assigned to IPST or a wait list control. Primary outcome was the change in depressive symptoms defined by a change in sum score on the Beck Depression Inventory Second Edition (BDI-II). Assessments took place at baseline (T0), within a week after the intervention (T1), and at 4 months follow-up (T2). Analyses were based on the intention-to-treat principle. Results: A total of 171 patients were randomized to IPST ( n = 85) or a wait list control ( n = 86). T1 was completed by 152 (89%) and T2 by 131 patients (77%). The IPST group and wait list control showed large significant improvements in depressive symptoms, but no differences were found between groups at T1 ( d = 0.23; 95% confidence interval (CI) = (−4.03, 1.08); p = 0.259) and T2 ( d = 0.01; 95% CI = (−2.80, 2.98); p = 0.953). Conclusion: We found no indication that IPST for MS patients with moderate or severe depression is effective in reducing depressive symptoms compared to a waiting list. Large improvements in the wait list control were unexpected and are discussed.

scholarly journals Effect of Continues Midwifery Support in Labor on the Childbirth Experience and Self-Esteem of Primipara Women: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Nasrin Soleimani ◽  
Mansoureh Refaei ◽  
Farideh Kazemi
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Esteem ◽  
Control Group ◽  
Randomized Controlled ◽  
Childbirth Experience ◽  
Cohen’S D ◽  
The Mean ◽  
Cohen's D

Abstract Background: The World Health Organization states that mothers during labor and delivery should be supported by people with whom they feel comfortable, because one of the non-pharmacological methods of relieving labor pain is the continued support of midwives in labor. The primary objectives of this study were to determine the effect of continuous midwifery support in labor on delivery experience and self-esteem of nulliparous women 6 weeks after delivery.Methods: This randomized controlled trial was performed in 2021 on 70 pregnant women admitted to the delivery ward who met the inclusion criteria. Participants were randomly allocated to two groups through balanced block randomization with a block size of 4. Participants completed a demographic and midwifery information questionnaire before entering the study. In the intervention group, in addition to routine labor care, the researcher was present at the mother's bedside and was present with the mother continuously throughout the labor and up to 2 hours after delivery and provided the necessary support. The control group received only routine labor and postpartum care. Six weeks after delivery, participants in both groups were contacted to complete the CEQ and Rosenberg self-esteem questionnaires. Finally, data were collected and analyzed. Significance level was considered 0.05.Results: By controlling the effect of duration of the first and second stages of labor as potential confounders, the mean (sd) of childbirth experience 6 weeks after delivery was 70.92 (7.07) in the intervention group and 59.69 (7.08) in the control group, and this difference was statistically significant (p <0.001). The amount of effect size indicates a very strong effect of the intervention on improving the childbirth experience (Cohen’s d = 1.69; 95% CI: 1.12, 2.26). Comparison of the mean of maternal self-esteem showed that this rate in the intervention group was 2 scores higher than the control group and this difference was statistically significant (p = 0.05). Cohen's d indicates the average effect of intervention on mothers' self-esteem score (Cohen's d = 0.56; 95% CI: 0.06, 1.05).Conclusions: Continuous support of the midwife in labor and up to 2 hours after delivery can lead to a better childbirth experience and increase the mother's self-esteem up to 6 weeks after delivery.Trial registration: IRCT ID: IRCT20201102049233N1, First Registration date: 2021-06-04

OS10.4.A The effects of SmartCare on neuro-oncology family caregivers’ distress: a randomized controlled trial

2021 ◽  
Vol 23 (Supplement_2) ◽  
pp. ii13-ii13
Author(s):  
F W Boele ◽  
J M Weimer ◽  
J Proudfoot ◽  
A L Marsland ◽  
T S Armstrong ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Family Caregivers ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Symptom Burden ◽  
Significant Group ◽  
Intention To Treat ◽  
Secondary Outcomes ◽  
Physical Consequences

Abstract BACKGROUND Patients with primary malignant brain tumors have high symptom burden and commonly rely on family caregivers for practical and emotional support. This can lead to negative mental and physical consequences for caregivers. We investigated effectiveness of an 8-week nurse-led online needs-based support program (SmartCare©) with and without online self-guided cognitive behavioral therapy (CBT) for depression compared to enhanced care as usual (ECAU) on depressive symptoms, caregiving-specific distress, anxiety, mastery, and burden. MATERIAL AND METHODS Family caregivers with depressive symptoms were randomized to three groups: SmartCare© plus/minus self-guided CBT, or ECAU. Primary outcomes (depressive symptoms (CES-D); caregiving-specific distress (Caregiver Needs Screen)) and secondary outcomes (anxiety (POMS-A), caregiver mastery (Caregiver Mastery Scale), and caregiver burden (Caregiver Reactions Assessment)) were assessed online. Intention to treat analyses of covariance corrected for baseline scores were performed for outcomes at four months. RESULTS In total, 120 family caregivers participated. Accrual and CBT engagement were lower than expected, therefore intervention groups were combined (n=80) and compared to ECAU (n=40). For depressive symptoms, no statistically significant group differences were found. Caregiving-specific distress decreased in the intervention group compared with ECAU (p=0.01, partial ɳ 2=0.08). Among secondary outcomes, there was a trend towards improvement in mastery for the intervention group compared with ECAU (p=0.08, partial ɳ 2=0.04). CONCLUSION SmartCare©, with or without self-guided CBT, reduced caregiving-specific distress with a trend towards improving mastery. SmartCare© has the potential to improve the lives of families coping with a brain tumor diagnosis.

583 Treating Insomnia in Youth Depression: A Randomized Controlled Trial of CBT for Depression vs. CBT for Insomnia

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A230-A230
Author(s):  
Shirley Xin Li ◽  
Ngan Yin chan ◽  
Siu Ping Lam ◽  
Tsz Ting Lui ◽  
Joey W Chan ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Post Intervention ◽  
Meaningful Improvement ◽  
Treatment Groups ◽  
Comorbid Insomnia ◽  
Cohen’S D ◽  
Significant Difference ◽  
Cohen's D ◽  
Group Cbt

Abstract Introduction Insomnia is often comorbid with depression in youths and both may reciprocally exacerbate clinical outcomes and lead to a constellation of detrimental consequences. The present study aimed to test the efficacy of cognitive behavioral therapy (CBT) for insomnia (CBT-I) and CBT for depression (CBT-D), when compared with waitlist control, in youths with comorbid insomnia and depression. Methods 112 participants aged 12–24 years old (67.9% female) with insomnia and depression according to DSM-5 diagnostic criteria were randomised to one of the following conditions: 8-week group CBT-I (n=33), 8-week group CBT-D (n=39), or waiting-list control (n=40). Insomnia (Insomnia Severity Index, ISI) and depressive symptoms (Hamilton Rating Scale for Depression, HAMD) were assessed at baseline and post-intervention. The two active treatment groups were additionally followed up at post-treatment one-month. Results Linear mixed model showed that both treatment groups (CBT-D: Cohen’s d = -0.44, p&lt;.001; CBT-I: Cohen’s d =-0.56, p&lt;.001) had significantly lower ISI scores at post-intervention follow-up, as compared to the waitlist group. There was a significant difference in clinically meaningful improvement in insomnia (a reduction of ISI score ≥ 6 from baseline to post-intervention follow-up) between the groups (CBT-I: 73.1%; CBT-D: 40.0%; WL: 28.6%; p=.002). Moreover, there was a significant difference in remission of depression (HAMD≤7) at post-intervention follow-up (CBT-D: 75.9%; CBT-I: 81.5%; WL: 22.9%) (p &lt;.001). Both CBT-D and CBT-I resulted in comparable improvements in insomnia and depressive symptoms at one-month follow-up (p&gt;.05). Conclusion Preliminary evidence from this study supports the efficacy of CBT-I for improving both sleep and mood in youths with comorbid insomnia and depression. Support (if any) This work was supported by Early Career Scheme, Research Grants Council, Hong Kong SAR (Ref. 27613017).

scholarly journals Telephone-based depression self-management in Hispanic adults with epilepsy: a pilot randomized controlled trial

2021 ◽  
Author(s):  
Tanya M Spruill ◽  
Daniel Friedman ◽  
Laura Diaz ◽  
Mark J Butler ◽  
Keith S Goldfeld ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Usual Care ◽  
Controlled Trial ◽  
Unmet Need ◽  
Management Program ◽  
Adverse Outcomes ◽  
Retention Rates ◽  
Self Management ◽  
Consent Rate ◽  
Hispanic Adults

Abstract Depression is associated with adverse outcomes in epilepsy but is undertreated in this population. Project UPLIFT, a telephone-based depression self-management program, was developed for adults with epilepsy and has been shown to reduce depressive symptoms in English-speaking patients. There remains an unmet need for accessible mental health programs for Hispanic adults with epilepsy. The purpose of this study was to evaluate the feasibility, acceptability, and effects on depressive symptoms of a culturally adapted version of UPLIFT for the Hispanic community. Hispanic patients with elevated depressive symptoms (n = 72) were enrolled from epilepsy clinics in New York City and randomized to UPLIFT or usual care. UPLIFT was delivered in English or Spanish to small groups in eight weekly telephone sessions. Feasibility was assessed by recruitment, retention, and adherence rates and acceptability was assessed by self-reported satisfaction with the intervention. Depressive symptoms (PHQ-9 scores) were compared between study arms over 12 months. The mean age was 43.3±11.3, 71% of participants were female and 67% were primary Spanish speakers. Recruitment (76% consent rate) and retention rates (86–93%) were high. UPLIFT participants completed a median of six out of eight sessions and satisfaction ratings were high, but rates of long-term practice were low. Rates of clinically significant depressive symptoms (PHQ-9 ≥5) were lower in UPLIFT versus usual care throughout follow-up (63% vs. 72%, 8 weeks; 40% vs. 70%, 6 months; 47% vs. 70%, 12 months). Multivariable-adjusted regressions demonstrated statistically significant differences at 6 months (OR = 0.24, 95% CI, 0.06–0.93), which were slightly reduced at 12 months (OR = 0.30, 95% CI, 0.08–1.16). Results suggest that UPLIFT is feasible and acceptable among Hispanic adults with epilepsy and demonstrate promising effects on depressive symptoms. Larger trials in geographically diverse samples are warranted.

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