scholarly journals A Brief Intervention to Increase Uptake and Adherence of an Internet-Based Program for Depression and Anxiety (Enhancing Engagement With Psychosocial Interventions): Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Philip J Batterham ◽  
Alison L Calear ◽  
Matthew Sunderland ◽  
Frances Kay-Lambkin ◽  
Louise M Farrer ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Psychosocial Interventions ◽  
P Uptake ◽  
Depression And Anxiety ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Difference ◽  
Clinical Trials Registry

BACKGROUND Psychosocial, self-guided, internet-based programs are effective in treating depression and anxiety. However, the community uptake of these programs is poor. Recent approaches to increasing engagement (defined as both uptake and adherence) in internet-based programs include brief engagement facilitation interventions (EFIs). However, these programs require evaluation to assess their efficacy. OBJECTIVE The aims of this hybrid implementation effectiveness trial are to examine the effects of a brief internet-based EFI presented before an internet-based cognitive behavioral therapy self-help program (<i>myCompass 2</i>) in improving engagement (uptake and adherence) with that program (primary aim), assess the relative efficacy of the <i>myCompass 2</i> program, and determine whether greater engagement was associated with improved efficacy (greater reduction in depression or anxiety symptoms) relative to the control (secondary aim). METHODS A 3-arm randomized controlled trial (N=849; recruited via social media) assessed the independent efficacy of the EFI and <i>myCompass 2</i>. The <i>myCompass 2</i> program was delivered with or without the EFI; both conditions were compared with an attention control condition. The EFI comprised brief (5 minutes), tailored audio-visual content on a series of click-through linear webpages. RESULTS Uptake was high in all groups; 82.8% (703/849) of participants clicked through the intervention following the pretest survey. However, the difference in uptake between the EFI + <i>myCompass 2</i> condition (234/280, 83.6%) and the <i>myCompass 2</i> alone condition (222/285, 77.9%) was not significant (n=565; <i>χ</i><sup>2</sup><sub>1</sub>=29.2; <i>P=</i>.09). In addition, there was no significant difference in the proportion of participants who started any number of modules (1-14 modules) versus those who started none between the EFI + <i>myCompass 2</i> (214/565, 37.9%) and the <i>myCompass 2</i> alone (210/565, 37.2%) conditions (n=565; <i>χ</i><sup>2</sup><sub>1</sub><0.1; <i>P=</i>.87). Finally, there was no significant difference between the EFI + <i>myCompass 2</i> and the <i>myCompass 2</i> alone conditions in the number of modules started (<i>U</i>=39366.50; <i>z</i>=−0.32; <i>P=</i>.75) or completed (<i>U</i>=39494.0; <i>z</i>=−0.29; <i>P=</i>.77). The <i>myCompass 2</i> program was not found to be efficacious over time for symptoms of depression (<i>F</i><sub>4,349.97</sub>=1.16; <i>P=</i>.33) or anxiety (<i>F</i><sub>4,445.99</sub>=0.12; <i>P=</i>.98). However, planned contrasts suggested that <i>myCompass 2</i> may have been effective for participants with elevated generalized anxiety disorder symptoms (<i>F</i><sub>4,332.80</sub>=3.50; <i>P=</i>.01). CONCLUSIONS This brief internet-based EFI did not increase the uptake of or adherence to an existing internet-based program for depression and anxiety. Individuals’ motivation to initiate and complete internet-based self-guided interventions is complex and remains a significant challenge for self-guided interventions. CLINICALTRIAL Australian New Zealand Clinical Trials Registry ACTRN12618001565235; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375839

scholarly journals Adverse Effects of Carbetocin versus Oxytocin in the Prevention of Postpartum Haemorrhage after Caesarean Section: A Randomized Controlled Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
D. Mannaerts ◽  
L. Van der Veeken ◽  
H. Coppejans ◽  
Y. Jacquemyn
Keyword(s):  
Heart Rate ◽  
Randomized Controlled Trial ◽  
Caesarean Section ◽  
Blood Loss ◽  
Controlled Trial ◽  
Hypotensive Effect ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Effect Difference ◽  
The Difference

Purpose. To compare the incidence of nausea, vomiting, and arterial hypotension between carbetocin and oxytocin to prevent haemorrhage after caesarean section (CS).Methods. A randomized controlled trial in term pregnant women undergoing planned CS. Groups were randomized to carbetocin or oxytocin. Blood pressure (BP), heart rate, presence of nausea/vomitus, and need for vasopressors were evaluated throughout surgery. Preoperative and postoperative haemoglobin and haematocrit levels were compared.Results. Fifty-eight women were randomized (carbetocinn=32; oxytocinn=26). Both medications had hypotensive effect, difference in BP for carbetocin versus oxytocin: systolic (14.4 ± 2.4 mmHg versus 8.5 ± 1.8 mmHg); diastolic (7.8 ± 1.6 mmHg versus 8.9 ± 3.0 mmHg) without significant difference between the drugs (p=0.1andp=0.7). Both groups had similar needs for vasopressors. The presence of nausea was not rare, but the difference was not statistically significant (p=0.4). Average blood loss was slightly lower in the carbetocin group but not statistically significant (p=0.8).Conclusion. In planned CS, a possible clinical significant lower incidence of nausea after carbetocin was noted but this was not statistically significant. There were no differences regarding BP, heart rate, the need for vasopressor, and blood loss. The study was registered in the International Journal of Clinical Trials (ISRCTN95504420, 2/2017).

365 Cognitive Behavioral Therapy and Light Dark Therapy for Postpartum Insomnia Symptoms: Findings from a Randomized Controlled Trial

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A145-A145
Author(s):  
Sumedha Verma ◽  
Nina Quin ◽  
Laura Astbury ◽  
Cornelia Wellecke ◽  
Joshua Wiley ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Light Therapy ◽  
Depression And Anxiety ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Self Help ◽  
Insomnia Symptoms

Abstract Introduction Symptoms of insomnia are common in the postpartum period and are associated with a range of negative outcomes. Despite this, interventions to improve maternal postpartum sleep remain scarce. Cognitive Behavioral Therapy (CBT) and Light Dark Therapy (LDT) target two different mechanisms to reduce sleep disturbance. This randomized controlled trial examined the efficacy of CBT and LDT against a treatment-as-usual (TAU) condition in reducing maternal postpartum insomnia symptoms. Methods Nulliparous women 4–12 months postpartum with self-reported symptoms of insomnia (Insomnia Severity Index scores [ISI] &gt;7) were included; excluded were those with: current severe health/psychiatric conditions, unsettled infant behaviors, sleep-affecting medication use and photosensitivity. Eligible women were randomized 1:1:1 to 6 weeks of CBT (CBT for insomnia and fatigue), LDT (morning bright light therapy, evening light hygiene), or TAU. Interventions were therapist-assisted and personalized through two telephone calls and included automated self-help intervention materials (i.e., emails) delivered over six weeks. Symptoms of insomnia (ISI; primary outcome), fatigue, sleepiness, depression, and anxiety were assessed at baseline, mid-intervention, post-intervention, and 1-month post-intervention. Analyses were intention-to-treat latent growth models. Results 114 women were randomized (mean age = 32.20 ± 4.62 years) and 108 women completed the intervention. Compared to TAU, symptoms of insomnia significantly reduced from baseline to post-intervention in both CBT and LDT groups (p-values &lt;.001), with very large effect sizes (d &gt; 1.5) at post-intervention; gains were maintained at follow-up. Fatigue symptoms significantly reduced in the CBT group (p&lt;.0001; d = 0.85) but not LDT (p = 0.11) compared to TAU at post-intervention; gains were maintained for CBT at follow-up. Group differences in sleepiness, depression, and anxiety were nonsignificant (all p &gt; 0.08). Conclusion Therapist-assisted self-help CBT and LDT with different therapeutic mechanisms are both efficacious for reducing maternal insomnia symptoms during the postpartum period. Findings were mixed for fatigue, sleepiness and mood. Future research on predictors of treatment responses is needed. Support (if any) Australian National Health and Medical Research Council, Department of Education RTP Scholarship. Lucimed SA supplied light therapy glasses. Funders had no role in design/implementation of the trial. ANZCTR: ACTRN12618000842268.

The effectiveness of a web-based psycho-education program in a community in Selangor, Malaysia: A randomized controlled trial (Preprint)

2020 ◽  
Author(s):  
Sherina Mohd-Sidik ◽  
Siti Fatimah Kader Maideen ◽  
Lekhraj Rampal ◽  
Firdaus Mukhtar
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Health Literacy ◽  
Mental Health Literacy ◽  
Controlled Trial ◽  
Control Group ◽  
Depression And Anxiety ◽  
Web Based ◽  
Randomized Controlled ◽  
Significant Difference

BACKGROUND Background Mental health problems namely depression and anxiety are the most common problems in the community. Often patients do not seek professional care due to the stigma attached to it. OBJECTIVE The study aimed to determine the effectiveness of a web-based psycho-education program in managing mild depression and anxiety. Methods METHODS A two-arm randomized controlled trial of a single blinded, parallel study comparing a four weeks of web-based psycho-education intervention program versus a wait list control group was carried out. The intervention program consisted of four sessions, with each session accessed on a weekly basis. Participants aged 18 years and above, who have participated in the first phase of this study, having access to internet and who are internet literate were invited to participate in the study. By using a random number table, 119 eligible and consented participants were randomly assigned to either the intervention or the control group using random number table. The primary outcomes were depression and anxiety score while the secondary outcome was mental health literacy score, which were all assessed at baseline, week 5 and week 12. Analysis was based on intention to treat analysis. RESULTS Significant difference in the mental health literacy score between the intervention and the control group was observed, F (1,117) = 20.149, p<0.001, n2=0.142. No significant difference was found in the depression (p= 0.361) and anxiety scores (p= 0.797). CONCLUSIONS The psycho-education intervention was effective in increasing the mental health literacy of the participants. CLINICALTRIAL The trial is registered in International Standard Randomized Controlled Trial, ISRCTN 39656144.

scholarly journals Comparison of Religious Cognitive Behavioral Therapy, Cognitive Behavioral Therapy, and Citalopram on Depression and Anxiety among Women with Breast Cancer: A Study Protocol for a Randomized Controlled Trial

2016 ◽  
Vol 9 (1) ◽  
pp. 59
Author(s):  
Seyed Hamzeh Hosseini ◽  
Alireza Rafiei ◽  
Ghasem Janbabai ◽  
Abdolhakim Tirgari ◽  
Aliasghar Zakavi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Cancer Patients ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Depression And Anxiety ◽  
Religious Attitude ◽  
Randomized Controlled

There has been evidence supporting the reduction of depression and anxiety by religious psychotherapy in cancer patients, however, there have been scarce randomized controlled trials. Therefore, there is a need for replication in a well-designed study to investigate the efficacy of these interventions among depressed women with breast cancer. A randomized controlled trial is designed to be conducted on 160 women with breast cancer. Participants will be screened for anxiety and depression diagnosed by clinical interview based on the DSM-IV criteria and the Hospital Anxiety Depression Scale. Golriz and Baraheni's Religious Attitude Questionnaire will be used to assess the religious attitude. Individuals meeting the prerequisites will be randomly allocated to four groups, each containing 40 participants, including three intervention groups (RCBT, CBT, and citalopram) and one control group (usual breast cancer treatment). An instrument by the EORTCQLQ-C30 and BR-23 will be used to measure the quality of life. Blood tests will be taken to assess biomarkers with the (ELISA) method. The results will determine whether RCBT is more effective than other treatments. If so, the outcomes of the study will have implications not only for the management of similar problems in cancer patients but also for the management of other chronic diseases.

A noninferiority cluster-randomized controlled trial on antibiotic postprescription review and authorization by trained general pharmacists and infectious disease clinical fellows

2018 ◽  
Vol 39 (10) ◽  
pp. 1154-1162 ◽  
Author(s):  
Pinyo Rattanaumpawan ◽  
Prasit Upapan ◽  
Visanu Thamlikitkul
Keyword(s):  
Infectious Disease ◽  
Randomized Controlled Trial ◽  
Clinical Response ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Favorable Clinical Response ◽  
The Difference ◽  
Cluster Randomized

AbstractObjectiveWe compared the effectiveness of antibiotic postprescription review and authorization (PPRA) determined by infectious disease (ID) clinical fellows with that of trained general pharmacists.MethodsWe conducted a noninferiority cluster-randomized controlled trial in 6 general medical wards at Siriraj Hospital in Bangkok, Thailand. Three wards were randomly assigned to the intervention (ie, the pharmacist PPRA group), and another 3 wards were assigned to the control (ie, the fellow PPRA group). We enrolled all patients in the study wards who received 1 or more doses of the targeted antibiotics: piperacillin/tazobactam, imipenem/cilastatin, and meropenem. The noninferiority margin was 10% for the favorable clinical response and 1.5 defined daily doses (DDDs) for the targeted antibiotics.ResultsWe enrolled 303 patients in the pharmacist PPRA group and 307 patients in the ID fellow PPRA group. The baseline and clinical characteristics were similar in the 2 groups. The difference in the favorable response of patients who received the targeted antibiotics (ie, the pharmacist PPRA group minus the fellow PPRA group) was 5.15% (95% confidence interval [CI], –2.69% to 12.98%); the difference in the DDD of targeted antibiotic use (ie, the pharmacist PPRA group minus the fellow PPRA group) was 0.62 (95% CI, –1.57 to 2.82). We observed no significant difference in the DDD of overall antibiotics, 28-day mortality, 28-day ID-related mortality, favorable microbiological outcome, or antibiotic-associated complications.ConclusionsWe confirmed the noninferiority of pharmacist PPRA in terms of favorable clinical response; however, noninferiority in targeted antibiotic consumption could not be established. Therefore, using trained general pharmacists rather than ID clinical fellows could be an alternative in a resource-limited setting.Clinical trials registration: clinicaltrials.gov identifier: NCT 01797133

scholarly journals Comparison of Religious Cognitive Behavioral Therapy, Cognitive Behavioral Therapy, and Citalopram on Depression and Anxiety among Women with Breast Cancer: A Study Protocol for a Randomized Controlled Trial

2016 ◽  
Vol 8 (1) ◽  
pp. 55
Author(s):  
Seyed Hamzeh Hosseini ◽  
Alireza Rafiei ◽  
Ghasem Janbabai ◽  
Abdolhakim Tirgari ◽  
Aliasghar Zakavi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Cancer Patients ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Depression And Anxiety ◽  
Religious Attitude ◽  
Randomized Controlled

There has been evidence supporting the reduction of depression and anxiety by religious psychotherapy in cancer patients, however, there have been scarce randomized controlled trials. Therefore, there is a need for replication in a well-designed study to investigate the efficacy of these interventions among depressed women with breast cancer. A randomized controlled trial is designed to be conducted on 160 women with breast cancer. Participants will be screened for anxiety and depression diagnosed by clinical interview based on the DSM-IV criteria and the Hospital Anxiety Depression Scale. Golriz and Baraheni's Religious Attitude Questionnaire will be used to assess the religious attitude. Individuals meeting the prerequisites will be randomly allocated to four groups, each containing 40 participants, including three intervention groups (RCBT, CBT, and citalopram) and one control group (usual breast cancer treatment). An instrument by the EORTCQLQ-C30 and BR-23 will be used to measure the quality of life. Blood tests will be taken to assess biomarkers with the (ELISA) method. The results will determine whether RCBT is more effective than other treatments. If so, the outcomes of the study will have implications not only for the management of similar problems in cancer patients but also for the management of other chronic diseases.

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