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.

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.

scholarly journals Using Psychological Artificial Intelligence (Tess) to Relieve Symptoms of Depression and Anxiety: Randomized Controlled Trial

2018 ◽  
Vol 5 (4) ◽  
pp. e64 ◽  
Author(s):  
Russell Fulmer ◽  
Angela Joerin ◽  
Breanna Gentile ◽  
Lysanne Lakerink ◽  
Michiel Rauws
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Cost Effective ◽  
Control Group ◽  
Depression And Anxiety ◽  
Symptoms Of Depression ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Unlimited Access ◽  
Group 1

Background Students in need of mental health care face many barriers including cost, location, availability, and stigma. Studies show that computer-assisted therapy and 1 conversational chatbot delivering cognitive behavioral therapy (CBT) offer a less-intensive and more cost-effective alternative for treating depression and anxiety. Although CBT is one of the most effective treatment methods, applying an integrative approach has been linked to equally effective posttreatment improvement. Integrative psychological artificial intelligence (AI) offers a scalable solution as the demand for affordable, convenient, lasting, and secure support grows. Objective This study aimed to assess the feasibility and efficacy of using an integrative psychological AI, Tess, to reduce self-identified symptoms of depression and anxiety in college students. Methods In this randomized controlled trial, 75 participants were recruited from 15 universities across the United States. All participants completed Web-based surveys, including the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder Scale (GAD-7), and Positive and Negative Affect Scale (PANAS) at baseline and 2 to 4 weeks later (T2). The 2 test groups consisted of 50 participants in total and were randomized to receive unlimited access to Tess for either 2 weeks (n=24) or 4 weeks (n=26). The information-only control group participants (n=24) received an electronic link to the National Institute of Mental Health’s (NIMH) eBook on depression among college students and were only granted access to Tess after completion of the study. Results A sample of 74 participants completed this study with 0% attrition from the test group and less than 1% attrition from the control group (1/24). The average age of participants was 22.9 years, with 70% of participants being female (52/74), mostly Asian (37/74, 51%), and white (32/74, 41%). Group 1 received unlimited access to Tess, with daily check-ins for 2 weeks. Group 2 received unlimited access to Tess with biweekly check-ins for 4 weeks. The information-only control group was provided with an electronic link to the NIMH’s eBook. Multivariate analysis of covariance was conducted. We used an alpha level of .05 for all statistical tests. Results revealed a statistically significant difference between the control group and group 1, such that group 1 reported a significant reduction in symptoms of depression as measured by the PHQ-9 (P=.03), whereas those in the control group did not. A statistically significant difference was found between the control group and both test groups 1 and 2 for symptoms of anxiety as measured by the GAD-7. Group 1 (P=.045) and group 2 (P=.02) reported a significant reduction in symptoms of anxiety, whereas the control group did not. A statistically significant difference was found on the PANAS between the control group and group 1 (P=.03) and suggests that Tess did impact scores. Conclusions This study offers evidence that AI can serve as a cost-effective and accessible therapeutic agent. Although not designed to appropriate the role of a trained therapist, integrative psychological AI emerges as a feasible option for delivering support. Trial Registration International Standard Randomized Controlled Trial Number: ISRCTN61214172; https://doi.org/10.1186/ISRCTN61214172.

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.

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