DepressionEAITDASNCT02614443
Effectiveness and Acceptability of Internet-delivered Treatment for Depression, Anxiety and Stress
A study testing Space from Depression, Space from Anxiety and Space from Stress in people with Depression and Anxiety, run by Silver Cloud Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Stress
- What is being tested?
- Space from Depression, Space from Anxiety and Space from Stress
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be at least 18 years of age. Participants must have self-reported mild to severe symptoms of depression (5-27+) according to PHQ-9, self-reported mild to severe symptoms of anxiety (5-21+) according to GAD-7, or self-reported mild to severe symptoms of stress (15-34+) according to the stress sub-scale of DASS-21.
Who cannot join
- Students who currently are in face-to-face therapy at UCCS or BHS will be excluded. Students who score in the "red zone" in terms of risk of self-harm on the screening questions routinely used at UCCS will not be referred to the study. Students who score greater than 0 on the PHQ-9 self-harm item during the initial screening phase will be automatically directed to be further evaluated and alerted that a counselor will try to reach them. Based on this further evaluation, they may be recommended to seek help from their health/counseling service and may/may not be eligible to participate in the study. They will be telephoned within 1 working day and contacted by email if they cannot be reached by phone.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Effectiveness and Acceptability of Internet-delivered Treatment for Depression, Anxiety and Stress in University Students: Protocol for an Open Feasibility Trial
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.
Read the detailed description
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.
- Conditions
- Depression, Anxiety, Stress
- Being tested
- Space from Depression, Space from Anxiety, Space from Stress
- Keywords
- Depression, Anxiety, Stress, Online interventions, University students, CBT
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Space from DepressionOther
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.
Space from AnxietyOther
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.
Space from StressOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Depression Condition | Experimental | 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. Receives: Other: Space from Depression |
| Anxiety Condition | Experimental | 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. Receives: Other: Space from Anxiety |
| Stress Condition | Experimental | 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. Receives: Other: Space from Stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stress sub-scale of Depression Anxiety and Stress Scale-21 (DASS-21)
Composed of 7-item sub-scale measuring symptoms of stress.
Measured: 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.
Measured: 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.
Measured: Baseline, postintervention at 8 weeks and 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silver Cloud Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Derek Richards, PhD, Study director, SilverCloud HealthPatricia Frazier, PhD, Principal investigator, University of MinnesotaStefan G. Hofmann, PhD, Principal investigator, Department of Psychological and Brain Sciences, Boston UniversityDeborah Beidel, PhD, Principal investigator, UCF RESTORES, Department of Psychology, University of Central FloridaPatrick A. Palmieri, PhD, Principal investigator, Center for the Treatment and Study of Traumatic Stress, Summa Health System, Akron, OhioJacqueline Mooney, MA, Principal investigator, SilverCloud HealthChristopher Bonner, MSc, Principal investigator, SilverCloud Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614443
- Sponsor's protocol ID
- EAITDAS
- Acronym
- EAITDAS
- Status last verified
- Sep 2018
- First submitted
- 19 Nov 2015
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593.
PubMed 15939837Kessler RC, Aguilar-Gaxiola S, Alonso J, Chatterji S, Lee S, Ormel J, Ustun TB, Wang PS. The global burden of mental disorders: an update from the WHO World Mental Health (WMH) surveys. Epidemiol Psichiatr Soc. 2009 Jan-Mar;18(1):23-33. doi: 10.1017/s1121189x00001421.
PubMed 19378696Cuijpers P, Smit F, Oostenbrink J, de Graaf R, Ten Have M, Beekman A. Economic costs of minor depression: a population-based study. Acta Psychiatr Scand. 2007 Mar;115(3):229-36. doi: 10.1111/j.1600-0447.2006.00851.x.
PubMed 17302623Rapaport MH, Clary C, Fayyad R, Endicott J. Quality-of-life impairment in depressive and anxiety disorders. Am J Psychiatry. 2005 Jun;162(6):1171-8. doi: 10.1176/appi.ajp.162.6.1171.
PubMed 15930066Richards D. Prevalence and clinical course of depression: a review. Clin Psychol Rev. 2011 Nov;31(7):1117-25. doi: 10.1016/j.cpr.2011.07.004. Epub 2011 Jul 23.
PubMed 21820991Day V, McGrath PJ, Wojtowicz M. Internet-based guided self-help for university students with anxiety, depression and stress: a randomized controlled clinical trial. Behav Res Ther. 2013 Jul;51(7):344-51. doi: 10.1016/j.brat.2013.03.003. Epub 2013 Mar 28.
PubMed 23639300Adlaf EM, Gliksman L, Demers A, Newton-Taylor B. The prevalence of elevated psychological distress among Canadian undergraduates: findings from the 1998 Canadian Campus Survey. J Am Coll Health. 2001 Sep;50(2):67-72. doi: 10.1080/07448480109596009.
PubMed 11590985American College Health Association (2010). National college health assessment reference group executive summary. Hanover, MD: American College Health Association.
Association for University and College Counseling Center Directors (2014). The Association for University and College Counseling Center Directors Annual Survey. Aurora, IL: Association for University and College Counseling Center Directors.
Rutter M, Sroufe LA. Developmental psychopathology: concepts and challenges. Dev Psychopathol. 2000 Summer;12(3):265-96. doi: 10.1017/s0954579400003023.
PubMed 11014739Dyson R, Renk K. Freshmen adaptation to university life: depressive symptoms, stress, and coping. J Clin Psychol. 2006 Oct;62(10):1231-44. doi: 10.1002/jclp.20295.
PubMed 16810671Hirai R, Frazier P, Syed M. Psychological and sociocultural adjustment of first-year international students: Trajectories and predictors. J Couns Psychol. 2015 Jul;62(3):438-52. doi: 10.1037/cou0000085. Epub 2015 May 11.
PubMed 25961754Wang PS, Berglund PA, Olfson M, Kessler RC. Delays in initial treatment contact after first onset of a mental disorder. Health Serv Res. 2004 Apr;39(2):393-415. doi: 10.1111/j.1475-6773.2004.00234.x.
PubMed 15032961Johnson EM, Coles ME. Failure and delay in treatment-seeking across anxiety disorders. Community Ment Health J. 2013 Dec;49(6):668-74. doi: 10.1007/s10597-012-9543-9. Epub 2012 Sep 29.
PubMed 23054147Cuijpers P, Sijbrandij M, Koole SL, Andersson G, Beekman AT, Reynolds CF 3rd. Adding psychotherapy to antidepressant medication in depression and anxiety disorders: a meta-analysis. World Psychiatry. 2014 Feb;13(1):56-67. doi: 10.1002/wps.20089.
PubMed 24497254
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Acceptability of Internet-delivered Treatment for Depression, Anxiety and Stress in University Students: Protocol for an Open Feasibility Trial
- ClinicalTrials.gov ID
- NCT02614443
- Acronym / sponsor ID
- EAITDAS / EAITDAS
- Conditions
- Depression, Anxiety, Stress
- Keywords
- Depression, Anxiety, Stress, Online interventions, University students, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Silver Cloud HealthUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Depression Condition | Experimental | Other: Space from DepressionParticipants 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. |
| Anxiety Condition | Experimental | Other: Space from AnxietyParticipants 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. |
| Stress Condition | Experimental | Other: Space from StressParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must be at least 18 years of age. Participants must have self-reported mild to severe symptoms of depression (5-27+) according to PHQ-9, self-reported mild to severe symptoms of anxiety (5-21+) according to GAD-7, or self-reported mild to severe symptoms of stress (15-34+) according to the stress sub-scale of DASS-21.
Key exclusion criteria (1 listed)
- Students who currently are in face-to-face therapy at UCCS or BHS will be excluded. Students who score in the "red zone" in terms of risk of self-harm on the screening questions routinely used at UCCS will not be referred to the study. Students who score greater than 0 on the PHQ-9 self-harm item during the initial screening phase will be automatically directed to be further evaluated and alerted that a counselor will try to reach them. Based on this further evaluation, they may be recommended to seek help from their health/counseling service and may/may not be eligible to participate in the study. They will be telephoned within 1 working day and contacted by email if they cannot be reached by phone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Space from DepressionDelivered 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. | Other | Depression Condition |
| Space from AnxietyDelivered 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. | Other | Anxiety Condition |
| Space from StressDelivered 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. | Other | Stress Condition |
Primary outcome
Change in Stress sub-scale of Depression Anxiety and Stress Scale-21 (DASS-21)
Time frame: Baseline, postintervention at 8 weeks and 3 month follow-up
Composed of 7-item sub-scale measuring symptoms of stress.
Change in Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, postintervention at 8 weeks and 3 month follow-up
A self-report measure of depression that has been widely used in screening, primary care, and research.
Change in Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline, postintervention at 8 weeks and 3 month follow-up
Comprises 7 items measuring symptoms and severity of GAD based on the DSM-IV diagnostic criteria for GAD.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Background: PubMed 15939837Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593.
- Background: PubMed 19378696Kessler RC, Aguilar-Gaxiola S, Alonso J, Chatterji S, Lee S, Ormel J, Ustun TB, Wang PS. The global burden of mental disorders: an update from the WHO World Mental Health (WMH) surveys. Epidemiol Psichiatr Soc. 2009 Jan-Mar;18(1):23-33. doi: 10.1017/s1121189x00001421.
- Background: PubMed 17302623Cuijpers P, Smit F, Oostenbrink J, de Graaf R, Ten Have M, Beekman A. Economic costs of minor depression: a population-based study. Acta Psychiatr Scand. 2007 Mar;115(3):229-36. doi: 10.1111/j.1600-0447.2006.00851.x.
- Background: PubMed 15930066Rapaport MH, Clary C, Fayyad R, Endicott J. Quality-of-life impairment in depressive and anxiety disorders. Am J Psychiatry. 2005 Jun;162(6):1171-8. doi: 10.1176/appi.ajp.162.6.1171.
- Background: PubMed 21820991Richards D. Prevalence and clinical course of depression: a review. Clin Psychol Rev. 2011 Nov;31(7):1117-25. doi: 10.1016/j.cpr.2011.07.004. Epub 2011 Jul 23.
- Background: PubMed 23639300Day V, McGrath PJ, Wojtowicz M. Internet-based guided self-help for university students with anxiety, depression and stress: a randomized controlled clinical trial. Behav Res Ther. 2013 Jul;51(7):344-51. doi: 10.1016/j.brat.2013.03.003. Epub 2013 Mar 28.
- Background: PubMed 11590985Adlaf EM, Gliksman L, Demers A, Newton-Taylor B. The prevalence of elevated psychological distress among Canadian undergraduates: findings from the 1998 Canadian Campus Survey. J Am Coll Health. 2001 Sep;50(2):67-72. doi: 10.1080/07448480109596009.
- BackgroundAmerican College Health Association (2010). National college health assessment reference group executive summary. Hanover, MD: American College Health Association.
- BackgroundAssociation for University and College Counseling Center Directors (2014). The Association for University and College Counseling Center Directors Annual Survey. Aurora, IL: Association for University and College Counseling Center Directors.
- Background: PubMed 11014739Rutter M, Sroufe LA. Developmental psychopathology: concepts and challenges. Dev Psychopathol. 2000 Summer;12(3):265-96. doi: 10.1017/s0954579400003023.
- Background: PubMed 16810671Dyson R, Renk K. Freshmen adaptation to university life: depressive symptoms, stress, and coping. J Clin Psychol. 2006 Oct;62(10):1231-44. doi: 10.1002/jclp.20295.
- Background: PubMed 25961754Hirai R, Frazier P, Syed M. Psychological and sociocultural adjustment of first-year international students: Trajectories and predictors. J Couns Psychol. 2015 Jul;62(3):438-52. doi: 10.1037/cou0000085. Epub 2015 May 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek Richards, PhD study director
SilverCloud Health
Patricia Frazier, PhD principal investigator
University of Minnesota
Stefan G. Hofmann, PhD principal investigator
Department of Psychological and Brain Sciences, Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Space from Depression, Space from Anxiety and Space from Stress in people with Depression and Anxiety, run by Silver Cloud Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Stress sub-scale of Depression Anxiety and Stress Scale-21 (DASS-21) (time frame: Baseline, postintervention at 8 weeks and 3 month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02614443, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.