An interventional study of Space from Depression and Space from Anxiety in Depression, Anxiety and Stress, sponsored by Silver Cloud Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-11.
Sponsored by Silver Cloud Health · Not applicable, Interventional, and Treatment
Among 3,706 studies in Depression with a site in United States — 576 open to participants now, 716 under way, 30 of them phase 3. Depression · United States.
Among the 3,706 studies in Depression with a site in United States, this one is the 1,177th largest by enrollment of the 3,313 interventional ones, is one of 130 that started in 2015, is one of 2,213 with no phase, and was the 1,640th registered.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 120 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →576 of the 3,706 studies in Depression with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 1,088 Depression studies recruiting now, 469 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 310 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →3,706 studies; the count open now beside each. This study's row is marked.
First in 1977; this study’s year is marked. 130 started in 2015.
Median enrollment 72 across the 3,313 interventional studies, 138 across the 371 observational. Of the 2,759 that completed or were terminated, 1,045 (38%) have results posted.
392 of 3,706 have an industry lead sponsor. The 10 most frequent:
Silver Cloud Health is the lead sponsor of 7 studies on the registry; none are open to participants now.
Silver Cloud Health has 7 studies filed under Depression — fewer than ten, so there is no comparison to draw.
299 of the studies in Depression with a site in United States that are under way reach primary completion within a year, 12 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05552053Phase 3Cedars-Sinai Medical CenterResources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women | 2026-12-31 |
| NCT06922110Phase 3Xenon Pharmaceuticals Inc.An Open-Label Study of Azetukalner in Major Depressive Disorder | 2027-01 |
| NCT05474846Phase 3M.D. Anderson Cancer CenterCombination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer | 2027-02-28 |
| NCT04777357Phase 3AbbVieA Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder. | 2027-03 |
| NCT07076407Phase 3Xenon Pharmaceuticals Inc.A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3) | 2027-05 |
Among the 3,706 studies in Depression with a site in United States, from their registry updates:
The aims of this study are to test the effectiveness and acceptability of internet-delivered treatment for depression, anxiety and stress in university students. These data will inform the methods for a future randomized controlled trial.
The trial will establish an initial estimate of the effectiveness of these online interventions for students in terms of within-group effect sizes associated with changes in depression, anxiety and stress from pre to post-intervention and follow-up. These data will be used to estimate the sample size for a future trial to ensure that the study is sufficiently powered. A conservative estimate using the 90% upper confidence limit will be used to inform the sample size calculation of the definitive RCT.
Acceptability of the intervention to participants will be assessed using data on usage and engagement with the intervention (e.g. percentage of participants completing each module, average number of log ins, average time spent per session and total time spent on the program). These data are acquired through the online SilverCloud system. Satisfaction with will be assessed through the use of a post-intervention questionnaire on satisfaction with accessing and using an online delivery format for treatment.
Depression, anxiety and stress are among the primary causes of disease rates worldwide and are the most prevalent mental health problems in the U.S. Each is associated with significant economic, personal, intrapersonal and societal losses including lower quality of life and increased mortality.
Depression, Anxiety and Stress in Students:
Depression and anxiety are also the most prevalent mental health problems among the student population. In the 2010 American College Health Survey, 48% of college and university students reported feeling overwhelming anxiety at least once in the previous year. Thirty-one percent reported feeling so depressed it was difficult to function at least once in the previous 12 months. More recently, University counseling and mental health services have reported an increase in the number of clients seeking services and in yearly visits.
The college years can be a highly stressful time in students' lives. This is particularly true of the period of transition to college as students are learning to cope with increased academic pressures. Students are at a developmental stage when newfound stressors can promote the onset of mental health difficulties. In addition to academic stress, international students can experience significant sociocultural adjustment demands.
Young adults between 17 and 25 years of age are reported to be at greater risk of developing a serious mental illness than individuals in other age groups. Although early diagnosis of mental disorders can be difficult, delayed diagnosis can often lead to treatment resistance and poorer longer-term outcomes. In addition, underachievement or failure at this point in life can cause long-term setbacks to individuals' self-esteem and future progress.
Treating Depression, Anxiety and Stress:
Depression, anxiety and stress disorders can each be treated effectively using medications; however, after completing a course of this type of treatment the chances of relapse are high, and equally successful psychological therapies are often preferred. Of these, cognitive-behavior therapy (CBT) is the most widely researched and CBT is recognized as the leading choice of treatment for depression and anxiety in terms of post-treatment improvements, maintaining progress, and preventing relapse. CBT also is effective for stress management. CBT is comprised of a variety of cognitive and behavioral approaches, each concerned with changing distressing thoughts and beliefs. Treatment is often comprised of self-monitoring and thought recording, behavioral activation, cognitive restructuring, and exposure.
Access to Treatment:
On a global scale, a significant number of individuals in need of treatment receive no medical diagnosis nor do they seek treatment. The worldwide treatment gap between those needing treatment for depression compared to those receiving treatment has been estimated at 56%; the gap in treatment for anxiety disorders has been estimated at 46%. Several factors prevent people from accessing treatment, such as waiting lists, lack of motivation, negative attitudes about treatment, and costs. Of those willing to seek treatment, many encounter a lack of trained professionals or are placed on a waiting list. Although students can often obtain mental health services on campus, many campuses have limited services or have wait lists for services because of the high demand. A survey of U.S. students with mental health problems revealed that common barriers to seeking services, even if they were available, were stigma, lack of time/accessibility, and wait lists. Internet-delivered interventions are one way to address these issues.
Internet-Delivered CBT (iCBT):
Internet-delivered CBT programs are specially designed for the treatment of specific disorders, and can be either clinician-guided or self-administered. When such interventions are used in the UK, 6-8 sessions is the recommended length of treatment. Many studies provide support for the utility and effectiveness of internet-delivered treatments for depression, anxiety and stress . Those with the additional feature of human support tend to produce greater results.
Several studies also have assessed the efficacy of online interventions for depression, stress, and anxiety for college students. Recent reviews of these studies have found evidence for the efficacy of these online interventions. However, most of these studies do not assess the efficacy of the interventions in the context of existing service delivery systems. Rather, many are RCTs assessing efficacy in convenience samples of students (e.g., Psychology majors). The current trial seeks to investigate the effectiveness and acceptability of internet-delivered interventions among university students seeking services and the procedures needed to incorporate these interventions into mental health delivery in U.S. universities. Additionally, it hopes to support and extend existing empirical evidence for SilverCloud programs.
University of Minnesota:
The University of Minnesota-Twin Cities is a public research university located in Minneapolis and St. Paul, Minnesota established in 1851. It is the oldest and largest campus within the University of Minnesota system and has the sixth-largest main campus student body in the United States, with 57,600 students. The university is organized into 19 colleges and schools.
Participants will be recruited through three units at the University of Minnesota-Twin Cities. The first is Student Counseling Services (SCS) which provides free short-term counseling to undergraduate and graduate students. The second is Boynton Mental Health Clinic (BMHC) which also provides short term psychological services to full-time students at the University of Minnesota. Unlike SCS, BMHC also has psychiatrists on staff and is affiliated with the university health service. Finally, the investigators will recruit participants through the International Student and Scholar Services (ISSS) office which provides counseling to foreign national students on campus.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants in this group will be offered the Space from Depression programme to be completed over an 8 week period. The programme is delivered through the online SilverCloud platform.
Other: Space from Depression
Participants in this group will be offered the Space from Anxiety programme to be completed over an 8 week period. The programme is delivered through the online SilverCloud platform.
Other: Space from Anxiety
Participants in this group will be offered the Space from Stress programme to be completed over an 8 week period. The programme is delivered through the online SilverCloud platform.
Other: Space from Stress
Delivered through the online SilverCloud platform, the program for the treatment of depression employs several innovative engagement strategies for improving the user experience. These are divided into several categories: personal, interactive, supportive, and social.
Delivered through the online SilverCloud platform, the program for the treatment of anxiety employs several innovative engagement strategies for improving the user experience. These are divided into several categories: personal, interactive, supportive, and social.
Delivered through the online SilverCloud platform, the program for the treatment of stress employs several innovative engagement strategies for improving the user experience. These are divided into several categories: personal, interactive, supportive, and social.
Change in Stress sub-scale of Depression Anxiety and Stress Scale-21 (DASS-21)
Composed of 7-item sub-scale measuring symptoms of stress.
Time frame: Baseline, postintervention at 8 weeks and 3 month follow-up
Change in Patient Health Questionnaire-9 (PHQ-9)
A self-report measure of depression that has been widely used in screening, primary care, and research.
Time frame: Baseline, postintervention at 8 weeks and 3 month follow-up
Change in Generalized Anxiety Disorder-7 (GAD-7)
Comprises 7 items measuring symptoms and severity of GAD based on the DSM-IV diagnostic criteria for GAD.
Time frame: Baseline, postintervention at 8 weeks and 3 month follow-up
Change in The Satisfaction with Treatment (SAT) Questionnaire
Satisfaction measure containing two qualitative questions asking participants to describe what they most liked and least liked about the online treatment.
Time frame: Postintervention at 8 weeks and 3 month follow-up
Plan to share: No
The record gives a start of Oct 2015, a primary completion of Sep 2017 and a completion of Sep 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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