Feasibility and Acceptability of a Healthy Nordic Diet Intervention for the Treatment of Depression: A Randomized Controlled Pilot Trial.
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SUBMITTER: Sabet JA
PROVIDER: S-EPMC7999972 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:A common setting where depression is identified and treated is in primary care, where there is a need for low-intensity and cost-effective interventions to be used as part of a stepped-care model. The current study involved a pilot, parallel-group, randomized controlled trial of a video self-help intervention for primary care patients based on acceptance and commitment therapy (ACT). The intervention, called LifeStories, consisted of storytelling vignettes of patients describing their use of ACT-consistent coping skills for depression. Primary care patients were recruited to determine feasibility, acceptability, and potential clinical effects of the intervention. Twenty-one participants were assigned to use LifeStories over a period of 4 weeks, and 19 participants were assigned to an attention-matched comparison group. Qualitative feedback indicated that participants using LifeStories found the intervention to be engaging and useful in transmitting key ACT principles. Furthermore, those receiving LifeStories rated their level of "transportation" or immersion in the videos higher than the control group. Both conditions showed large improvements in levels of depression at a 12-week follow-up. There were no significant differences in symptom outcomes between groups; however, because this was a pilot study, it was not powered to detect differences between interventions. Both conditions additionally showed smaller effect size changes in psychological flexibility, a key ACT mechanism. The results suggest LifeStories to be a feasible and acceptable psychological intervention that may improve depression, and further research is warranted to determine its effectiveness as part of a stepped-care approach to treating depression in primary care.
| S-EPMC7322697 | biostudies-literature
Project description: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.
| S-EPMC7250140 | biostudies-literature
Project description:BackgroundThree to 22% of youth undergoing surgery develop chronic postsurgical pain (CPSP). Negative biases in pain memories (i.e., recalling higher levels of pain as compared to initial reports) are a risk factor for CPSP development. Children's memories for pain are modifiable. Existing memory-reframing interventions reduced negatively biased memories associated with procedural pain and pain after minor surgery. However, not one study has tested the feasibility and acceptability of the memory-reframing intervention in youth undergoing major surgery.AimsThe current pilot randomized clinical trial (RCT; NCT03110367; clinicaltrials.gov) examined the feasibility and acceptability of, as well as adherence to, a memory reframing intervention.MethodsYouth undergoing a major surgery reported their baseline and postsurgery pain levels. Four weeks postsurgery, youth and one of their parents were randomized to receive control or memory-reframing instructions. Following the instructions, parents and youth reminisced about the surgery either as they normally would (control) or using the memory-reframing strategies (intervention). Six weeks postsurgery, youth completed a pain memory interview; parents reported intervention acceptability. Four months postsurgery, youth reported their pain.ResultsSeventeen youth (76% girls, Mage = 14.1 years) completed the study. The intervention was feasible and acceptable. Parents, but not youth, adhered to the intervention principles. The effect sizes of the intervention on youth pain memories (ηp 2 = 0.22) and pain outcomes (ηp 2 = 0.23) were used to inform a larger RCT sample size.ConclusionsMemory reframing is a promising avenue in pediatric pain research. Larger RCTs are needed to determine intervention efficacy to improve pain outcomes.
| S-EPMC9196744 | biostudies-literature
Project description:Interventions are needed which can successfully modify more than one disease risk factor at a time, but much remains to be learned about the acceptability, feasibility, and effectiveness of multiple risk factor (MRF) interventions. To address these issues and inform future intervention development, we conducted a randomized pilot trial (n = 52). This study was designed to assess the feasibility and acceptability of the Step Up program, a MRF cognitive-behavioral program designed to improve participants' mental and physical well-being by reducing depressive symptoms, promoting smoking cessation, and increasing physical activity.Participants were recruited from a large health care organization and randomized to receive usual care treatment for depression, smoking, and physical activity promotion or the phone-based Step Up counseling program plus usual care. Participants were assessed at baseline, three and six months.The intervention was acceptable to participants and feasible to offer within a healthcare system. The pilot also offered important insights into the optimal design of a MRF program. While not powered to detect clinically significant outcomes, changes in target behaviors indicated positive trends at six month follow-up and statistically significant improvement was also observed for depression. Significantly more experimental participants reported a clinically significant improvement (50% reduction) in their baseline depression score at four months (54% vs. 26%, OR = 3.35, 95% CI [1.01-12.10], p = 0.05) and 6 months (52% vs. 13%, OR = 7.27, 95% CI [1.85-37.30], p = 0.004)Overall, results suggest the Step Up program warrants additional research, although some program enhancements may be beneficial. Key lessons learned from this research are shared to promote the understanding of others working in this field.The trial is registered with ClinicalTrials.gov (NCT00644995).
| S-EPMC3072336 | biostudies-literature
Project description:BackgroundAvailable smartphone-based interventions for depression predominantly use evidence-based strategies from cognitive-behavioral therapy (CBT), but patient engagement and reported effect sizes are small. Recently, studies have demonstrated that smartphone-based interventions combining CBT with gamified approach-avoidance bias modification training (AAMT) can foster patient engagement and reduce symptoms of several mental health problems.ObjectiveBased on these findings, we developed a gamified smartphone-based intervention, mentalis Phoenix (MT-Phoenix), and hypothesized the program would both engage patients and produce preliminary evidence for the reduction of depressive symptoms.MethodsTo test this hypothesis, we evaluated MT-Phoenix in a randomized controlled pilot trial including 77 individuals with elevated depression scores (Patient Health Questionnaire-9 scores ≥5). Participants were either instructed to train for 14 days with MT-Phoenix or assigned to a waitlist control condition. Engagement with the intervention was measured by assessing usage data. The primary outcome was reduction in depressive symptom severity at postassessment.ResultsData from this pilot trial shows that participants in the intervention group used the smartphone-based intervention for 46% of all days (6.4/14) and reported a significantly greater reduction of depressive symptoms than did participants in the control condition (F1,74=19.34; P=.001), with a large effect size (d=1.02). Effects were sustained at a 3-month follow-up.ConclusionsA gamified smartphone-based intervention combining CBT with AAMT may foster patient engagement and effectively target depressive symptoms. Future studies should evaluate the effectiveness of this intervention in a phase 3 trial using clinical samples. Moreover, the intervention should be compared to active control conditions.Trial registrationGerman Clinical Trial Registry DRKS00012769; https://tinyurl.com/47mw8du7.
| S-EPMC8335612 | biostudies-literature
Project description:BackgroundDiet and exercise may be associated with quality of life and survival in men with prostate cancer.ObjectiveThis study aimed to determine the feasibility and acceptability of a remotely delivered web-based behavioral intervention among men with prostate cancer.MethodsWe conducted a multi-site 4-arm pilot randomized controlled trial of a 3-month intervention (TrueNTH Community of Wellness). Eligibility included self-reported prostate cancer diagnosis, having a personal device that connected to the internet, age ?18 years, and ability to read English and receive text messages and emails. Men receiving chemotherapy or radiation, or those who reported contraindications to exercise, could participate with physician clearance. Participants were randomized (1:1:1:1) to additive intervention levels: website; website and personalized diet and exercise prescription; website, personalized prescription, Fitbit, and text messages; and website, personalized prescription, Fitbit, text messages, and 2 30-minute phone calls-one with an exercise trainer and one with a registered dietician. Primary outcomes were feasibility (accrual and attrition) and acceptability (survey data and website use). We described self-reported diet and exercise behavior at the time of enrollment, 3 months, and 6 months as secondary outcomes.ResultsIn total, 202 men consented and were randomized between August 2017 and September 2018 (level 1: 49, level 2: 51, level 3: 50, level 4: 52). A total of 160 men completed the onboarding process and were exposed to their randomly assigned intervention (38, 38, 42, and 42 in levels 1, 2, 3, and 4, respectively). The follow-up rate was 82.7% (167/202) at 3 months and 77.2% (156/202) at 6 months. Participants had a median age of 70 years and were primarily White and college educated. Website visit frequency over the 3-month intervention period increased across levels (median: 2, 9, 11, and 16 visits for levels 1, 2, 3, and 4, respectively). Most were satisfied or very satisfied with the intervention (20/39, 51%; 27/42, 64%; 23/44, 52%; and 27/42, 64% for levels 1, 2, 3, and 4, respectively). The percentage of men who reported being very satisfied was highest among level 4 participants (10/42, 24% vs 4/39, 10%; 5/42, 12%; and 5/44, 11% for levels 1, 2, and 3, respectively). Dissatisfaction was highest in level 1 (5/39, 13% vs 1/42, 2%; 3/44, 7%; and 2/42, 5% for levels 2, 3, and 4, respectively). We observed small improvements in diet and physical activity at 3 months among men in level 4 versus those in level 1.ConclusionsA web-based, remotely delivered, tailored behavioral intervention for men with prostate cancer is feasible. Future studies are warranted to increase the effect of the intervention on patient behavior while maintaining sustainability and scalability as well as to design and implement interventions for more diverse populations.Trial registrationClinicalTrials.gov NCT03406013; http://clinicaltrials.gov/ct2/show/NCT03406013.
| S-EPMC7808895 | biostudies-literature
Project description:BackgroundMany traditional lifestyle interventions use calorie prescriptions, but most individuals have difficulty sustaining calorie tracking and thus weight loss. In contrast, whole food plant-based diets (WFPBDs) have previously shown significant weight loss without this issue. However, most WFPBD interventions are face-to-face and time-intensive, and do not leverage gold standard behavioral strategies for health behavior change.ObjectiveThis open pilot trial was the first to evaluate the feasibility of a fully featured, remotely delivered behavioral weight loss intervention using an ad libitum WFPBD.MethodsOver 12 weeks, participants (N=15) with overweight or obesity received a newly designed program that integrated behavioral weight loss and a WFPBD prescription via weekly web-based modules and brief phone coaching calls. Assessments were performed at baseline, midtreatment (6 weeks), and after treatment (12 weeks).ResultsThe intervention was rated as highly acceptable (mean 4.40 out of 5, SE 0.18), and attrition was low (6.7%). In all, intention-to-treat analyses revealed that 69% (10.4/15) of the participants lost 5% of their weight (mean -5.89, SE 0.68 kg). Predefined benchmarks for quality of life were met.ConclusionsA pilot digital behavioral weight loss intervention with a non-energy-restricted WFPBD was feasible, and the mean acceptability was high. Minimal contact time (80-150 minutes of study interventionist time per participant over 12 weeks) led to clinically relevant weight loss and dietary adherence for most participants (10.4/15, 69% and 11.8/15, 79%, respectively), and quality of life improvements (reliable change indices >1.53). We hope that this work will serve as a springboard for future larger scale randomized controlled studies evaluating the efficacy of such programs for weight loss, dietary change, and quality of life.Trial registrationClinicalTrials.gov NCT04892030; https://clinicaltrials.gov/ct2/show/NCT04892030.
| S-EPMC9264123 | biostudies-literature
Project description:OBJECTIVES:We examined the feasibility and acceptability of a portable bright light intervention and its impact on sleep disturbance and depressive symptoms in older adults. METHODS:One-arm prevention intervention pilot study of the Re-Timer (Re-Timer Pty Ltd, Adelaide, Australia) bright light device (worn 30 minutes daily for 2 weeks) in 1 older adults (age 65?+?years) with subsyndromal symptoms of depression and poor sleep quality. Participants were assessed on intervention acceptability and adherence, depressive symptoms (Patient Health Questionnaire- 9), and sleep (Pittsburgh Sleep Quality Index, Insomnia Severity Index, actigraphy and daily diary reports). RESULTS:The Re-Timer device was rated positively by participants, and, on average, participants only missed 1 day of utilization. Although depressive symptoms declined and self-reported sleep improved, improvement was seen largely before the start of intervention. CONCLUSIONS:An effective preventive intervention that is targeted towards a high risk group of older adults has the potential to reduce distress and costly health service use.
| S-EPMC6181116 | biostudies-literature
Project description:BACKGROUND:As adults age, their physical activity decreases and sedentary behavior increases, leading to increased risk of negative health outcomes. Wearable electronic activity monitors have shown promise for delivering effective behavior change techniques. However, little is known about the feasibility and acceptability of non-Fitbit wearables (Fitbit, Inc, San Francisco, California) combined with telephone counseling among adults aged more than 55 years. OBJECTIVE:The purpose of our study was to determine the feasibility, acceptability, and effect on physical activity of an intervention combining a wearable physical activity monitor, tablet device, and telephone counseling among adults aged 55-79 years. METHODS:Adults (N=40, aged 55-79 years, body mass index=25-35, <60 min of activity per week) were randomized to receive a 12-week intervention or to a wait list control. Intervention participants received a Jawbone Up24 monitor, a tablet with the Jawbone Up app installed, and brief weekly telephone counseling. Participants set daily and weekly step goals and used the monitor's idle alert to notify them when they were sedentary for more than 1 h. Interventionists provided brief counseling once per week by telephone. Feasibility was measured using observation and study records, and acceptability was measured by self-report using validated items. Physical activity and sedentary time were measured using ActivPAL monitors following standard protocols. Body composition was measured using dual-energy x-ray absorptiometry scans, and fitness was measured using a 6-min walk test. RESULTS:Participants were 61.48 years old (SD 5.60), 85% (34/40) female, 65% (26/40) white. Average activity monitor wear time was 81.85 (SD 3.73) of 90 days. Of the 20 Up24 monitors, 5 were reported broken and 1 lost. No related adverse events were reported. Acceptability items were rated at least 4 on a scale of 1-5. Effect sizes for most outcomes were small, including stepping time per day (d=0.35), steps per day (d=0.26), sitting time per day (d=0.21), body fat (d=0.17), and weight (d=0.33). CONCLUSIONS:The intervention was feasible and acceptable in this population. Effect sizes were similar to the sizes found using other wearable electronic activity monitors, indicating that when combined with telephone counseling, wearable activity monitors are a potentially effective tool for increasing physical activity and decreasing sedentary behavior. TRIAL REGISTRATION:Clinicaltrials.gov NCT01869348; https://clinicaltrials.gov/ct2/show/NCT01869348 (Archived by WebCite at http://www.webcitation.org/6odlIolqy).
| S-EPMC5359416 | biostudies-literature
Project description:BackgroundHeart failure (HF) is a burdensome condition and a leading cause of 30-day hospital readmissions in the United States. Clinical and social factors are key drivers of hospitalization. These 2 strategies, digital platforms and home-based social needs care, have shown preliminary effectiveness in improving adherence to clinical care plans and reducing acute care use in HF. Few studies, if any, have tested combining these 2 strategies in a single intervention.ObjectiveThis study aims to perform a pilot randomized controlled trial assessing the acceptability, feasibility, and preliminary effectiveness of a 30-day digitally-enabled community health worker (CHW) intervention in HF.MethodsAdults hospitalized with a diagnosis of HF at an academic hospital were randomly assigned to receive digitally-enabled CHW care (intervention; digital platform +CHW) or CHW-enhanced usual care (control; CHW only) for 30 days after hospital discharge. Primary outcomes were feasibility (use of the platform) and acceptability (willingness to use the platform in the future). Secondary outcomes assessed preliminary effectiveness (30-day readmissions, emergency department visits, and missed clinic appointments).ResultsA total of 56 participants were randomized (control: n=31; intervention: n=25) and 47 participants (control: n=28; intervention: n=19) completed all trial activities. Intervention participants who completed trial activities wore the digital sensor on 78% of study days with mean use of 11.4 (SD 4.6) hours/day, completed symptom questionnaires on 75% of study days, used the blood pressure monitor 1.1 (SD 0.19) times/day, and used the digital weight scale 1 (SD 0.13) time/day. Of intervention participants, 100% responded very or somewhat true to the statement "If I have access to the [platform] moving forward, I will use it." Some (n=9, 47%) intervention participants indicated they required support to use the digital platform. A total of 19 (100%) intervention participants and 25 (89%) control participants had ≥5 CHW interactions during the 30-day study period. All intervention (n=19, 100%) and control (n=26, 93%) participants who completed trial activities indicated their CHW interactions were "very satisfying." In the full sample (N=56), fewer participants in the intervention group were readmitted 30 days after hospital discharge compared to the control group (n=3, 12% vs n=8, 26%; P=.12). Both arms had similar rates of missed clinic appointments and emergency department visits.ConclusionsThis pilot trial of a digitally-enabled CHW intervention for HF demonstrated feasibility, acceptability, and a clinically relevant reduction in 30-day readmissions among participants who received the intervention. Additional investigation is needed in a larger trial to determine the effect of this intervention on HF home management and clinical outcomes.Trial registrationClinicaltrials.gov NCT05130008; https://clinicaltrials.gov/study/NCT05130008.International registered report identifier (irrid)RR2-10.2196/55687.
| S-EPMC11342011 | biostudies-literature