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U-CARE: Internet-based stepped care with interactive support and cognitive behavioral therapy for reduction of anxiety and depressive symptoms in cancer--a clinical trial protocol.

ABSTRACT: Approximately 20-30% of patients with cancer experience a clinically relevant level of emotional distress in response to disease and treatment. This in itself is alarming but it is even more problematic because it is often difficult for physicians and nurses to identify cancer patients who experience clinically relevant levels of anxiety and depression symptoms. This can result in persistent distress and can cause human suffering as well as costs for individuals and to the community.Applying a multi-disciplinary and design-oriented approach aimed at attaining new evidence-based knowledge in basic and applied psychosocial oncology, this protocol will evaluate an intervention to be implemented in clinical practice to reduce cancer patient anxiety and depression. A prospective randomized design will be used.The overarching goal of the intervention is to promote psychosocial health among patients suffering from cancer by means of self-help programmes delivered via an Internet platform. Another goal is to reduce costs for individuals and society, caused by emotional distress in response to cancer.Following screening to detect levels of patient distress, patients will be randomized to standard care or a stepped care intervention. For patients randomized to the intervention, step 1 will consist of self-help material, a chat forum where participants will be able to communicate with each other, and a Frequently Asked Questions (FAQ) section where they can ask questions and get answers from an expert. Patients in the intervention group who still report symptoms of anxiety or depression after access to step 1 will be offered step 2, which will consist of cognitive behavioral therapy (CBT) administered by a personal therapist. The primary end point of the study is patients' levels of anxiety and depression, evaluated longitudinally during and after the intervention.There is a lack of controlled studies of the psychological and behavioral processes involved in this type of intervention for anxiety and depressive disorders. Since anxiety and depressive symptoms are relatively common in patients with cancer and the availability of adequate support efforts is limited, there is a need to develop evidence-based stepped care for patients with cancer, to be delivered via the Internet.ClinicalTrials.gov Identifier: NCT01630681.

SUBMITTER: Mattsson S

PROVIDER: S-EPMC3848442 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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U-CARE: Internet-based stepped care with interactive support and cognitive behavioral therapy for reduction of anxiety and depressive symptoms in cancer--a clinical trial protocol.

Mattsson Susanne S Alfonsson Sven S Carlsson Maria M Nygren Peter P Olsson Erik E Johansson Birgitta B

BMC cancer 20130911

<h4>Background</h4>Approximately 20-30% of patients with cancer experience a clinically relevant level of emotional distress in response to disease and treatment. This in itself is alarming but it is even more problematic because it is often difficult for physicians and nurses to identify cancer patients who experience clinically relevant levels of anxiety and depression symptoms. This can result in persistent distress and can cause human suffering as well as costs for individuals and to the com ...[more]

PMID: 24024826

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Project description:Poor mental health is a growing concern among young people during the coronavirus disease 2019 (COVID-19) pandemic. The aim of this study was to assess the associations of Internet addiction with depressive symptoms, anxiety symptoms, and stress in higher education students during the COVID-19 pandemic, as well as to examine these mental health problems in the context of study-related characteristics. The research sample consisted of 3,099 participants from the Czech Republic (CZ: 1,422) and Slovak Republic (SK: 1,677). The Internet Addiction Test (IAT), the Generalized Anxiety Disorder (GAD-7) scale, the Patient Health Questionnaire for depressive symptoms (PHQ-9), and the Perceived Stress Scale (PSS) were used to measure mental health problems. The analyses also included demographic data (gender and age) and study-related characteristics (form of study, degree of study, field of study, distance between college and home, and housing during the semester). Based on the results of frequency and descriptive analyses, the prevalence of mental health problems was high. The most serious levels of Internet addiction (IAT cut-off point ≥ 50), to which attention should be paid, were found in 3.5% of Czech and 6.2% of Slovak students. Using the standard cut-off point of GAD-7 ≥ 10, 14.1% of Czech and 11.6% of Slovak students were identified with anxiety symptoms. Regarding the PHQ-9 with the cut-off point ≥ 10, 23.4% of Czech and 19.1% of Slovak students had depressive symptoms, which should be addressed. Using the PSS cut-off point ≥ 27, 12.9% of Czech students and 9.1% of Slovak students perceived high stress. The quantile regression analysis showed that Internet addiction was positively associated with anxiety symptoms, depressive symptoms, and stress in all of the analyzed cases (p-value < 0.001). In terms of study-related characteristics, the binomial logistic regression analysis revealed that risk factors for mental health problems in Czech and Slovak students were mainly full-time form of study and living away from home during the semester. Internet addiction, anxiety symptoms, depressive symptoms, and stress are issues that require increased attention, and professionals and policy-makers should implement interventions to effectively prevent and help students with psychological problems.

Project description:BackgroundInternet-based cognitive behavioral therapy (I-CBT) leads to a reduction of fatigue severity and disability in adults with chronic fatigue syndrome (CFS). However, not all patients profit and it remains unclear how I-CBT is best embedded in the care of CFS patients.ObjectiveThis study aimed to compare the efficacy of stepped care, using therapist-assisted I-CBT, followed by face-to-face (f2f) cognitive behavioral therapy (CBT) when needed, with f2f CBT (treatment as usual [TAU]) on fatigue severity. The secondary aim was to investigate treatment efficiency.MethodsA total of 363 CFS patients were randomized to 1 of the 3 treatment arms (n=121). There were 2 stepped care conditions that differed in the therapists' feedback during I-CBT: prescheduled or on-demand. When still severely fatigued or disabled after I-CBT, the patients were offered f2f CBT. Noninferiority of both stepped care conditions to TAU was tested using analysis of covariance. The primary outcome was fatigue severity (Checklist Individual Strength). Disabilities (Sickness Impact Profile -8), physical functioning (Medical Outcomes Survey Short Form-36), psychological distress (Symptom Checklist-90), and proportion of patients with clinically significant improvement in fatigue were the secondary outcomes. The amount of invested therapist time was compared between stepped care and TAU. Exploratory comparisons were made between the stepped care conditions of invested therapist time and proportion of patients who continued with f2f CBT.ResultsNoninferiority was indicated, as the upper boundary of the one-sided 98.75% CI of the difference in the change in fatigue severity between both forms of stepped care and TAU were below the noninferiority margin of 5.2 (4.25 and 3.81, respectively). The between-group differences on the secondary outcomes were also not significant (P=.11 to P=.79). Both stepped care formats required less therapist time than TAU (median 8 hours, 9 minutes and 7 hours, 25 minutes in stepped care vs 12 hours in TAU; P<.001). The difference in therapist time between both stepped care formats was not significant. Approximately half of the patients meeting step-up criteria for f2f CBT after I-CBT did not continue.ConclusionsStepped care, including I-CBT followed by f2f CBT when indicated, is noninferior to TAU of f2f CBT and requires less therapist time. I-CBT for CFS can be used as a first step in stepped care.Trial registrationNederlands Trial Register NTR4809; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4809 (Archived by WebCite at http://www.webcitation.org/74SWkw1V5).

Project description:BACKGROUND:Internet-delivered treatments for depressive symptoms have proved to be successful in high-income Western countries. There may be potential for implementing such treatments in low- and middle-income countries such as Colombia, where access to mental health services is limited. OBJECTIVE:The objective of this study was to assess the efficacy of a culturally adapted cognitive behavioral internet-delivered treatment for college students with depressive symptoms in Colombia. METHODS:This was a randomized controlled trial with a 3-month follow-up. The program comprised seven modules. A total of 214 Colombian college students were recruited. They were assessed and randomly assigned to either the treatment group (n=107) or a waiting list (WL) control group (n=107). Participants received weekly support from a trained supporter. The primary outcome was symptoms of depression, as measured by the Patient Health Questionnaire - 9, and the secondary outcomes were anxiety symptoms assessed by the Generalized Anxiety Disorder questionnaire - 7. Other measures, including satisfaction with treatment, were evaluated after 7 weeks. RESULTS:Research attrition and treatment dropouts were high in this study. On average, 7.6 sessions were completed per user. The mean time spent on the program was 3 hours and 18 min. The linear mixed model (LMM) showed significant effects after treatment (t197.54=-5.189; P<.001) for the treatment group, and these effects were maintained at the 3-month follow-up (t39.62=4.668; P<.001). Within-group results for the treatment group yielded a large effect size post treatment (d=1.44; P<.001), and this was maintained at the 3-month follow-up (d=1.81; P<.001). In addition, the LMM showed significant differences between the groups (t197.54=-5.189; P<.001). The results showed a large effect size between the groups (d=0.91; P<.001). In the treatment group, 76.0% (16/107) achieved a reliable change, compared with 32.0% (17/107) in the WL control group. The difference between groups was statistically significant (X22=10.5; P=.001). CONCLUSIONS:This study was the first contribution to investigating the potential impact of a culturally adapted internet-delivered treatment on depressive symptoms for college students as compared with a WL control group in South America. Future research should focus on identifying variables associated both with premature dropout and treatment withdrawal at follow-up. TRIAL REGISTRATION:ClinicalTrials.gov NCT03062215; https://clinicaltrials.gov/ct2/show/NCT03062215.

Project description:BACKGROUND:Individuals with newly diagnosed cancer may experience impaired health in several aspects and often have a large need for information and support. About 30% will experience symptoms of anxiety and depression, with varying needs of knowledge and support. Despite this, many of these patients lack appropriate support. Internet-based support programs may offer a supplement to standard care services, but must be carefully explored from a user perspective. OBJECTIVE:The purpose of this study was to explore the participants' perceptions of the relevance and benefits of an internet-based stepped care program (iCAN-DO) targeting individuals with cancer and concurrent symptoms of anxiety and depression. METHODS:We performed a qualitative study with an inductive approach, in which we used semistructured questions to interview 15 individuals using iCAN-DO. We analyzed the interviews using content analysis. RESULTS:The analysis found 17 subcategories regarding the stepped care intervention, resulting in 4 categories. Participants described the need for information as large and looked upon finding information almost as a survival strategy when receiving the cancer diagnosis. iCAN-DO was seen as a useful, reliable source of information and support. It was used as a complement to standard care and as a means to inform next of kin. Increased knowledge was a foundation for continued processing of participants' own feelings. The optimal time to gain access to iCAN-DO would have been when being informed of the diagnosis. The most common denominator was feeling acknowledged and supported, but with a desire for further adaptation of the system to each individual's own situation and needs. CONCLUSIONS:Users saw the internet-based stepped care program as safe and reliable and used it as a complement to standard care. Similar interventions may gain from more personalized contents, being integrated into standard care, or using symptom tracking to adjust the contents. Offering this type of program close to diagnosis may provide benefits to users. TRIAL REGISTRATION:ClincalTrials.gov NCT-01630681; https://clinicaltrials.gov/ct2/show/NCT01630681.

Project description:BackgroundAntenatal depression and antenatal anxiety adversely affect several obstetric and foetal outcomes, and increase the rate of postnatal mental illness. Thus, to tackle these challenges the need for social support during pregnancy is vital. However, an extensive literature search failed to show a published study on the relationship between domains of social support and antenatal depressive, as well as antenatal anxiety symptoms in Australia. This study examined the association between domains of social support and antenatal depressive and anxiety symptoms among Australian women.MethodsThe current study used data obtained from the 1973-78 cohort of the Australian Longitudinal Study on Women's Health (ALSWH), focusing upon women who reported being pregnant (n = 493). Depression and anxiety were assessed using the 10 item Center for Epidemiological Studies Depression (CES-D-10) scale, and the 9-item Goldberg Anxiety and Depression scale (GADS) respectively. The 19 item-Medical Outcomes Study Social Support index (MOSS) was used to assess social support. A logistic regression model was used to examine the associations between domains of social support and antenatal depressive and anxiety symptoms after adjusting for potential confounders.ResultThe current study found 24.7 and 20.9% of pregnant women screened positive for depressive and anxiety symptoms respectively. After adjusting for potential confounders, our study found that the odds of antenatal depressive symptoms was about four and threefold higher among pregnant women who reported low emotional/informational support (AOR = 4.75; 95% CI: 1.45, 15.66; p = 0.010) and low social support (overall support) (AOR = 3.26; 95%CI: 1.05, 10.10, p = 0.040) respectively compared with their counterpart. In addition, the odds of antenatal anxiety symptoms was seven times higher among pregnant women who reported low affectionate support/positive social interaction (AOR = 7.43; 95%CI: 1.75, 31.55; p = 0.006).ConclusionA considerable proportion of pregnant Australian women had depressive symptoms and/or anxiety symptoms, which poses serious health concerns. Low emotional/informational support and low affectionate support/positive social interaction have a significant association with antenatal depressive and anxiety symptoms respectively. As such, targeted screening of expectant women for social support is essential.

Project description:ImportanceIn most countries, young people with obsessive-compulsive disorder have limited access to specialist cognitive behavioral therapy (CBT), a first-line treatment.ObjectiveTo investigate whether internet-delivered CBT implemented in a stepped-care model is noninferior to in-person CBT for pediatric obsessive-compulsive disorder.Design, setting and participantsA randomized clinical noninferiority trial conducted at 2 specialist child and adolescent mental health clinics in Sweden. Participants included 152 individuals aged 8 to 17 years with obsessive-compulsive disorder. Enrollment began in October 2017 and ended in May 2019. Follow-up ended in April 2020.InterventionsParticipants randomized to the stepped-care group (n = 74) received internet-delivered CBT for 16 weeks. Nonresponders at the 3-month follow-up were then offered a course of traditional face-to-face treatment. Participants randomized to the control group (n = 78) immediately received in-person CBT for 16 weeks. Nonresponders at the 3-month follow-up received additional face-to-face treatment.Main outcomes and measuresThe primary outcome was the masked assessor-rated Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score at the 6-month follow-up. The scale includes 10 items rated from 0 (no symptoms) to 4 (extreme symptoms), yielding a total score range of 0 to 40, with higher scores indicating greater severity. Assessors were masked to treatment allocation at pretreatment, posttreatment, 3-month follow-up, and 6-month follow-up assessments. The predefined noninferiority margin was 4 points on the CY-BOCS.ResultsAmong the 152 randomized participants (mean age, 13.4 years; 94 [62%] females), 151 (99%) completed the trial. At the 3-month follow-up, 34 participants (46%) in the stepped-care group and 23 (30%) in the in-person CBT group were nonresponders. At the 6-month follow-up, the CY-BOCS score was 11.57 points in the stepped-care group vs 10.57 points in the face-to-face treatment group, corresponding to an estimated mean difference of 0.91 points ([1-sided 97.5% CI, -∞ to 3.28]; P for noninferiority = .02). Increased anxiety (30%-36%) and depressive symptoms (20%-28%) were the most frequently reported adverse events in both groups. There were 2 unrelated serious adverse events (1 in each group).Conclusions and relevanceAmong children and adolescents with obsessive-compulsive disorder, treatment with an internet-delivered CBT program followed by in-person CBT if necessary compared with in-person CBT alone resulted in a noninferior difference in symptoms at the 6-month follow-up. Further research is needed to understand the durability and generalizability of these findings.Trial registrationClinicalTrials.gov Identifier: NCT03263546.

Dataset Information

U-CARE: Internet-based stepped care with interactive support and cognitive behavioral therapy for reduction of anxiety and depressive symptoms in cancer--a clinical trial protocol.

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U-CARE: Internet-based stepped care with interactive support and cognitive behavioral therapy for reduction of anxiety and depressive symptoms in cancer--a clinical trial protocol.

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