scholarly journals Acceptability, Feasibility, and Preliminary Efficacy of a Resilience-Oriented Family Intervention to Prevent Adolescent HIV and Depression: A Pilot Randomized Controlled Trial

2020 ◽  
Vol 32 (1) ◽  
pp. 67-81
Author(s):  
Caroline Kuo ◽  
Catherine Mathews ◽  
Danielle Giovenco ◽  
Millicent Atujuna ◽  
William Beardslee ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
South African ◽  
Controlled Trial ◽  
Family Intervention ◽  
Hiv Risk Behavior ◽  
Post Intervention ◽  
Inconsistent Condom ◽  
Intervention Protocol ◽  
Adolescent Parent ◽  
Single Blind

We tested the acceptability, feasibility, and preliminary efficacy of Our Family Our Future, a resilience-oriented intervention engaging families in prevention of adolescent HIV and depression. South African adolescents, 13–15 years of age, with mild depressive symptoms, were randomized to intervention or wait-list using parallel assignment in a single-blind trial. HIV risk behavior and depression were evaluated at baseline, 1, and 3 months. We examined intervention satisfaction, fidelity, trial retention, and preliminary efficacy. One hundred-ninety-six adolescent-parent dyads completed eligibility screening and baseline, and n = 73 dyads were randomized. All families ranked intervention quality as good or excellent. Over 90% were satisfied with content. Facilitators were adherent to intervention protocol. All families were retained in post-intervention assessments. Intervention recipients reported diminished depressive symptoms, inconsistent condom use, and sexual activity, as well as increased HIV testing. Our Family Our Future is highly acceptable and feasible and should be tested in a future efficacy trial.

scholarly journals DREAMS-START (Dementia RElAted Manual for Sleep; STrAtegies for RelaTives) for people with dementia and sleep disturbances: a single-blind feasibility and acceptability randomized controlled trial

2018 ◽  
Vol 31 (2) ◽  
pp. 251-265 ◽  
Author(s):  
Gill Livingston ◽  
Julie A. Barber ◽  
Kirsi M. Kinnunen ◽  
Lucy Webster ◽  
Simon D. Kyle ◽  
...  
Keyword(s):  
Sleep Disorders ◽  
Sleep Disturbances ◽  
Light Exposure ◽  
Controlled Trial ◽  
Intervention Group ◽  
Pharmacological Therapy ◽  
Post Intervention ◽  
Night Time ◽  
People With Dementia ◽  
Single Blind

ABSTRACTBackground:40% of people with dementia have disturbed sleep but there are currently no known effective treatments. Studies of sleep hygiene and light therapy have not been powered to indicate feasibility and acceptability and have shown 40–50% retention. We tested the feasibility and acceptability of a six-session manualized evidence-based non-pharmacological therapy; Dementia RElAted Manual for Sleep; STrAtegies for RelaTives (DREAMS-START) for sleep disturbance in people with dementia.Methods:We conducted a parallel, two-armed, single-blind randomized trial and randomized 2:1 to intervention: Treatment as Usual. Eligible participants had dementia and sleep disturbances (scoring ≥4 on one Sleep Disorders Inventory item) and a family carer and were recruited from two London memory services and Join Dementia Research. Participants wore an actiwatch for two weeks pre-randomization. Trained, clinically supervised psychology graduates delivered DREAMS-START to carers randomized to intervention; covering Understanding sleep and dementia; Making a plan (incorporating actiwatch information, light exposure using a light box); Daytime activity and routine; Difficult night-time behaviors; Taking care of your own (carer's) sleep; and What works? Strategies for the future. Carers kept their manual, light box, and relaxation recordings post-intervention. Outcome assessment was masked to allocation. The co-primary outcomes were feasibility (≥50% eligible people consenting to the study) and acceptability (≥75% of intervention group attending ≥4 intervention sessions).Results:In total, 63out of 95 (66%; 95% CI: 56–76%) eligible referrals consented between 04/08/2016 and 24/03/2017; 62 (65%; 95% CI: 55–75%) were randomized, and 37 out of 42 (88%; 95% CI: 75–96%) adhered to the intervention.Conclusions:DREAM-START for sleep disorders in dementia is feasible and acceptable.

scholarly journals A food-based dietary strategy lowers blood pressure in a low socio-economic setting: a randomised study in South Africa

2008 ◽  
Vol 11 (12) ◽  
pp. 1397-1406 ◽  
Author(s):  
Karen E Charlton ◽  
Krisela Steyn ◽  
Naomi S Levitt ◽  
Nasheeta Peer ◽  
Deborah Jonathan ◽  
...  
Keyword(s):  
Blood Pressure ◽  
South African ◽  
Controlled Trial ◽  
Control Diet ◽  
Diet Group ◽  
Post Intervention ◽  
Intervention Effect ◽  
Double Blind ◽  
Cation Content ◽  
The Impact

AbstractObjectiveTo assess the impact of a food-based intervention on blood pressure (BP) in free-living South African men and women aged 50–75 years, with drug-treated mild-to-moderate hypertension.MethodsA double-blind controlled trial was undertaken in eighty drug-treated mild-to-moderate hypertensive subjects randomised to an intervention (n40) or control (n40) arm. The intervention was 8-week provision of six food items with a modified cation content (salt replacement (SOLO™), bread, margarine, stock cubes, soup mix and a flavour enhancer) and 500 ml of maas (fermented milk)/d. The control diet provided the same quantities of the targeted foods but of standard commercial composition and 500 ml/d of artificially sweetened cooldrink.FindingsThe intervention effect estimated as the contrast of the within-diet group changes in BP from baseline to post-intervention was a significant reduction of 6·2 mmHg (95 % CI 0·9, 11·4) for systolic BP. The largest intervention effect in 24 h BP was for wake systolic BP with a reduction of 5·1 mmHg (95 % CI 0·4, 9·9). For wake diastolic BP the reduction was 2·7 mmHg (95 % CI −0·2, 5·6).ConclusionsModification of the cation content of a limited number of commonly consumed foods lowers BP by a clinically significant magnitude in treated South African hypertensive patients of low socio-economic status. The magnitude of BP reduction provides motivation for a public health strategy that could be adopted through lobbying of the food industry by consumer and health agencies.

scholarly journals Exercise and Horticultural Programs for Older Adults with Depressive Symptoms and Memory Problems: A Randomized Controlled Trial

2019 ◽  
Vol 9 (1) ◽  
pp. 99 ◽  
Author(s):  
Hyuma Makizako ◽  
Kota Tsutsumimoto ◽  
Takehiko Doi ◽  
Keitaro Makino ◽  
Sho Nakakubo ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
Exercise Group ◽  
Control Group ◽  
Control Groups ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Memory Problems

Depressive symptoms and memory problems are risk factors for dementia. Exercise can reduce these in older people, and horticultural activity can benefit people with dementia. This study assessed the efficacy of exercise and horticultural interventions for community-dwelling older adults with depressive symptoms and mild memory decline. In this randomized controlled trial, older adults (n = 89) were assigned to exercise, horticultural, or control groups. Exercise and horticultural programs included 20 weekly 90-min sessions. The control group attended two 90-min classes. Outcomes were assessed at baseline, and then 6- and 12-months post-intervention. Primary outcome measures were the Geriatric Depression Scale-15 (GDS-15) and Wechsler Memory Scale-Revised. Walking speed, two-minute walking test scores, social network, life space, and subjective daily physical activity were secondary outcome measures. Compared with the control group, the exercise group obtained higher immediate and delayed recall logical memory scores, and the increase in immediate recall scores remained 12-months post-intervention. Two-minute walking performance improved in the exercise group, but not after 12 months. GDS-15 scores showed no significant improvements. The horticultural and control groups showed no differences. Exercise may improve memory, while horticultural activity may not. The effects of exercise and horticultural interventions on depressive symptoms remain unclear.

Benefit-Finding Intervention Delivered Individually to Alzheimer Family Caregivers: Longer-Term Outcomes of a Randomized Double-Blind Controlled Trial

2019 ◽  
Vol 75 (9) ◽  
pp. 1884-1893 ◽  
Author(s):  
Sheung-Tak Cheng ◽  
Emily P M Mak ◽  
Timothy Kwok ◽  
Helene Fung ◽  
Linda C W Lam
Keyword(s):  
Depressive Symptoms ◽  
Controlled Trial ◽  
Well Being ◽  
Benefit Finding ◽  
Post Intervention ◽  
Double Blind ◽  
Interaction Terms ◽  
Positive Aspects Of Caregiving ◽  
Secondary Outcomes

Abstract Objectives To examine the longer-term effects of benefit-finding on caregivers’ depressive symptoms (primary outcome), and global burden, role overload, psychological well-being, and positive aspects of caregiving (secondary outcomes). Method Ninety-six Hong Kong Chinese caregivers of relatives with Alzheimer’s disease were randomly assigned to receive the benefit-finding intervention (BFT) or one of the two control conditions, namely, simplified psychoeducation (lectures only; SIM-PE) or standard psychoeducation (STD-PE). Caregivers received four biweekly one-to-one interventions of 3 hours each at their own homes. We focused on outcomes measured at 4- and 10-month follow-ups. The trajectories of intervention effects were modeled by BFT × time and BFT × time2 interaction terms. Results Mixed-effects regression showed significant BFT × time2 interaction effects on depressive symptoms against both control conditions, suggesting diminishing BFT effects over time. Z tests showed that, compared with controls, BFT participants reported substantial reductions in depressive symptoms at 4-month follow-up (d = −0.85 and −0.75 vs. SIM-PE and STD-PE, respectively). For depressive symptoms measured at 10-month follow-up, BFT was indistinguishable from STD-PE, whereas a moderate effect was observed in comparison with SIM-PE (d = −0.52). Moreover, positive aspects of caregiving, but not other secondary outcomes, continued to show intervention effect up to 10-month follow-up. Discussion Benefit-finding is an efficacious intervention for depressive symptoms in Alzheimer caregivers, with strong effects in the medium-term post-intervention and possible moderate effects in the longer-term post-intervention.

scholarly journals Parent BMI Increase 2 to 5 Years Post-study Related to Change in Age but Independent of Other Sociodemographics, Health Behavior, and Study Engagement (P16-001-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Brenda Abu ◽  
Barbara Lohse ◽  
Leslie Cunningham-Sabo
Keyword(s):  
Physical Activity ◽  
Health Behavior ◽  
Low Income ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Family Intervention ◽  
Activity Level ◽  
Nutrition Intervention ◽  
Post Intervention ◽  
Age Change

Abstract Objectives Characterize parent (P) weight change 2–5 y post participation in Fuel for Fun (FFF) a controlled trial of a school and family intervention focused on culinary and physical activity experiences for 4th grade youth. Methods P who had participated with their 4th grader in FFF were recruited via email to enroll in a follow-up (FFF-FU) assessment. FFF-FU survey set included measures from the original study and new items pertinent to P of adolescents. Physical activity was measured with the IPAQ; low income was denoted as using an income-based program or worry about money for food. Height, weight, age in FFF and FFF-FU were self-reported. Perimenopausal age included 47 y within BL and FFF-FU. Youth in FFF cohorts 1 and 4 were controls and cohorts 2 and 3 included the multi-component intervention. P were enrolled in 1 of 4 treatments varying in type and intensity. FFF and FFF-FU data were collected online using the Qualtrics platform. FFF P completed surveys at baseline (BL), post-intervention, and 4 months post-study. FFF-FU data were collected spring 2018, about 2 to 5 years years post-BL. Data were analyzed with repeated measures controlling for BL or FFF-FU sociodemographics, engagement, health behaviors. Results Of the 418 FFF P, 127 completed FFF-FU surveys (mean age 42.5 6.0 y) with 115 providing weight and height. FFF-FU sample was female (88%), white (84%), active (44% high activity), educated (69% college degree or higher), but had lower BMI and fewer with low income than FFF P. Of FFF-FU providing heights/weights at the 4 assessments, mean (SE) BMIs were 24.2 (0.5), 24.4 (0.5), 24.6 (0.6) and 25.7 (0.6) respectively. Change in BMI was significant after controlling for age, stress, ethnicity, sex, physical activity level, P treatment and engagement, but not when BL to FFU-FU change in age or perimenopausal age were controlled. The significantly greater increase in BMI for P of intervention youth than controls persisted when controlling for sociodemographic and health behavior findings, but not when BL to FFF-FU age change, perimenopausal age or activity level were controlled. Conclusions Significant weight gain by P of youth in a nutrition intervention 2 to 5 years post-study was unrelated to stress, ethnicity, activity level, income, but was related to the FFF-FU age change from BL and perimenopausal age. Funding Sources NIFA.

Impact of a Behavioral Sleep Intervention in Adolescents With ADHD: Feasibility, Acceptability, and Preliminary Effectiveness From a Pilot Open Trial

2021 ◽  
pp. 108705472110569
Author(s):  
Stephen P. Becker ◽  
Kara M. Duraccio ◽  
Craig A. Sidol ◽  
Chaya E. M. Fershtman ◽  
Kelly C. Byars ◽  
...  
Keyword(s):  
Sleep Problems ◽  
Controlled Trial ◽  
Preliminary Evidence ◽  
Post Treatment ◽  
Open Trial ◽  
Post Intervention ◽  
Sleep Diaries ◽  
Adolescent Parent ◽  
Pre Treatment

Objective: An open trial tested the feasibility, acceptability, and preliminary effectiveness of a behavioral sleep intervention in adolescents with ADHD. Method: Fourteen adolescents (ages 13–17 years; 50% male) with ADHD and co-occurring sleep problems received the cognitive-behavioral-based Transdiagnostic Sleep and Circadian Intervention for Youth (TranS-C). Adolescent, parent, and teacher ratings, actigraphy, and daily sleep diaries were collected at pre-intervention, post-intervention, and 3-month follow-up. Results: Adolescents experienced moderate to large improvements in sleep, mental health symptoms, and daily life executive functioning from pre-treatment to post-treatment, and improvements were generally maintained at 3 months. Pre-intervention, 71.4% of adolescents were classified as poor sleepers and this was reduced to 21.4% and 28.6% at post-treatment and follow-up, respectively. Conclusion: This study provides strong preliminary evidence that TranS-C improves sleep and associated outcomes in adolescents with ADHD and co-occurring sleep problems. A randomized controlled trial is needed to rigorously test the efficacy of TranS-C in this population.

scholarly journals Prevention of Depressive Symptoms and Promotion of Well-being in Adolescents: A Randomized Controlled Trial of the Smile Program

2019 ◽  
Vol 35 (2) ◽  
pp. 300-313
Author(s):  
Óscar Sánchez-Hernández ◽  
Francisco X. Méndez ◽  
Manuel Ato ◽  
Judy Garber
Keyword(s):  
Depressive Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Behavioral Approach ◽  
Control Group ◽  
Post Intervention ◽  
Post Test ◽  
Intervention Condition

This study addressed the development and evaluation of the Smile Program whose main objective was the prevention of depression and the promotion of well-being in adolescents. The program is based on interventions that have been shown to be efficacious (a cognitive-behavioral approach). Participants were 89 adolescents (mean age = 13.88 years; SD = 0.95) recruited from a sample of 1212 students from seven schools. Results showed a significant reduction in self-reported depressive symptoms in the intervention group (n= 51) as compared to youth in the control group (n= 38). Based on parents’ report (n=56), youth in the intervention group had significantly better self-esteem at post-test as compared to youth in the control group. At four months post intervention, youth in the intervention group had higher psychological well-being than those in the control group; at the 8-month follow-up, youth in the intervention condition reported better family self-concept.

scholarly journals EFFECTS OF AN ART GALLERY INTERVENTION IN PEOPLE LIVING WITH DEMENTIA: A PILOT STUDY

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S52-S52
Author(s):  
Nathan M D'Cunha ◽  
Andrew J McKune ◽  
Stephen Isbel ◽  
Ekavi N Georgousopoulou ◽  
Jane Kellett ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Interleukin 6 ◽  
Controlled Trial ◽  
Total Sample ◽  
Post Intervention ◽  
Art Gallery ◽  
Physiological Outcomes ◽  
Pituitary Adrenal Axis

Abstract Art gallery programs tailored to the needs of people living with dementia are becoming more popular worldwide. This study aimed to observe the effects of six consecutive weekly discussion-based small group visits to the National Gallery of Australia Art and Dementia program on the salivary cortisol (SC) diurnal rhythm, salivary interleukin-6, quality of life (QoL), depressive symptoms, and cognitive function. Twenty-five participants (17 female; mean age 84.6 ± 7.27 years) completed the study with data collection at baseline, post-intervention, and at a six-week follow-up. Statistical methods were selected based on data distribution. The waking to evening (WE) SC ratio was altered (p = 0.016) (Baseline: 1.35 (1.19, 1.64), Post-intervention: 1.72 (1.54, 1.96), Follow-up: 1.44 (1.22, 1.79)) in the 22 participants who provided viable saliva samples. The WE SC ratio was higher post-intervention compared with baseline (p = 0.011), indicating a more dynamic SC rhythm, but returned to baseline levels at follow-up (p = 0.020). Interleukin-6 levels were unchanged (p = 0.664). In the total sample, no improvements in QoL (Proxy) (p = 0.165) were observed. However, self-reported depressive symptoms differed (p = 0.006), decreasing post-intervention (2.00 (1.00, 2.00)) compared with baseline (3.00 (2.00, 4.50)) (p = 0.015), and verbal fluency was affected (p = 0.027), improving from baseline (2.00 (0.00, 3.00)) to post-intervention (2.00 (0.50, 4.00)) (p = 0.027). Art and Dementia programs appear to have quantifiable benefits, including improved hypothalamic-pituitary-adrenal axis function, justifying a longer controlled trial inclusive of physiological outcomes.

scholarly journals Mechanisms of rumination change in adolescent depression (RuMeChange): study protocol for a randomised controlled trial of rumination-focused cognitive behavioural therapy to reduce ruminative habit and risk of depressive relapse in high-ruminating adolescents

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Henrietta Roberts ◽  
Rachel H. Jacobs ◽  
Katie L. Bessette ◽  
Sheila E. Crowell ◽  
Mindy Westlund-Schreiner ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Controlled Trial ◽  
Inferior Frontal Gyrus ◽  
Preventive Therapy ◽  
Self Report ◽  
Phase Iii ◽  
Feasibility Trial ◽  
Response Scale ◽  
Post Intervention ◽  
Depressive Rumination

Abstract Background Adolescent-onset depression often results in a chronic and recurrent course, and is associated with worse outcomes relative to adult-onset depression. Targeting habitual depressive rumination, a specific known risk factor for relapse, may improve clinical outcomes for adolescents who have experienced a depressive episode. Randomized controlled trials (RCTs) thus far have demonstrated that rumination-focused cognitive behavioral therapy (RFCBT) reduces depressive symptoms and relapse rates in patients with residual depression and adolescents and young adults with elevated rumination. This was also observed in a pilot RCT of adolescents at risk for depressive relapse. Rumination can be measured at the self-report, behavioral, and neural levels- using patterns of connectivity between the Default Mode Network (DMN) and Cognitive Control Network (CCN). Disrupted connectivity is a putative important mechanism for understanding reduced rumination via RFCBT. A feasibility trial in adolescents found that reductions in connectivity between DMN and CCN regions following RFCBT were correlated with change in rumination and depressive symptoms. Method This is a phase III two-arm, two-stage, RCT of depression prevention. The trial tests whether RFCBT reduces identified risk factors for depressive relapse (rumination, patterns of neural connectivity, and depressive symptoms) in adolescents with partially or fully remitted depression and elevated rumination. In the first stage, RFCBT is compared to treatment as usual within the community. In the second stage, the comparator condition is relaxation therapy. Primary outcomes will be (a) reductions in depressive rumination, assessed using the Rumination Response Scale, and (b) reductions in resting state functional magnetic resonance imaging connectivity of DMN (posterior cingulate cortex) to CCN (inferior frontal gyrus), at 16 weeks post-randomization. Secondary outcomes include change in symptoms of depression following treatment, recurrence of depression over 12 months post-intervention period, and whether engagement with therapy homework (as a dose measure) is related to changes in the primary outcomes. Discussion RFCBT will be evaluated as a putative preventive therapy to reduce the risk of depressive relapse in adolescents, and influence the identified self-report, behavioral, and neural mechanisms of change. Understanding mechanisms that underlie change in rumination is necessary to improve and further disseminate preventive interventions. Trial registration ClinicalTrials.gov Identifier: NCT03859297, registered 01 March 2019.

scholarly journals Enhancing Social Interaction in Depression (SIDE study): protocol of a randomised controlled trial on the effects of a Cognitively Based Compassion Training (CBCT) for couples

BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e020448 ◽  
Author(s):  
Corina Aguilar-Raab ◽  
Marc N Jarczok ◽  
Marco Warth ◽  
Martin Stoffel ◽  
Friederike Winter ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Social Interaction ◽  
Eye Tracking ◽  
Relationship Quality ◽  
Social Functioning ◽  
Rating Scale ◽  
Depressive Symptomatology ◽  
Controlled Trial ◽  
Post Intervention ◽  
Treatment As Usual

IntroductionPositive social interactions (PSIs) and stable relationships can exert substantial benefits on health. However, patients suffering from depression benefit less from these health-promoting effects. Moreover, relationship quality and even partners’ health has been found to be negatively affected by depressive symptomatology, which may result in overall impairments in social functioning of a romantic couple. Psychobiological research indicates that these impairments may be accompanied by a maladaptive regulation of the patient’s neuroendocrine response to external stressors. Concerning the improvement of social functioning, first studies showed promising results of “Cognitively Based Compassion Training (CBCT®)”. However, randomised trials are still scarce. Previous programmes did not involve participation of the patient’s romantic partner. Therefore, the present study aims to investigate whether a CBCT® programme adapted for couples (CBCT®-fC) can improve depressive symptoms, distress, social interaction skills and the neurobiological regulation of stress.Methods and analysisCouples with the female partner suffering from depression will be invited to participate in a pre-to-post intervention assessment on two consecutive days, respectively, involving a standardised PSI task, eye-tracking, ECG recordings, saliva-sampling, blood-sampling and questionnaire data. After baseline assessment, participating couples will be randomised to either a 10 week CBCT®-fC or to a treatment as usual control condition. The primary endpoint is the reduction of depressive symptoms measured by the Hamilton Depression Rating Scale. Secondary outcomes encompass self-rated depression (Beck Depression Inventory), attention towards the partners face during PSI (eye tracking), stress-related biomarkers (cortisol, α-amylase, interleukin (IL)-1ß/IL-6, heart rate variability), methylation of oxytocin-receptor-genes and serotonin-transporter-genes and self-ratings of psychological constructs such as relationship quality and empathy.Ethics and disseminationEthical approval has been obtained by the Ethics Committee of the Medical Faculty Heidelberg. Results will be presented in international, peer-reviewed journals and on conferences in the field of clinical psychology and psychiatry.Trial registration numberNCT03080025.

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