An interventional study of Space from Depression and Space from Anxiety in Depressive Disorder, Anxiety Disorders and Depression, sponsored by Silver Cloud Health. Terminated at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2018-09-10.
Sponsored by Silver Cloud Health · Not applicable, Interventional, and Treatment
Among 318 studies in Depressive Disorder with a site in United States — 38 open to participants now, 45 under way, 2 of them phase 3. Depressive Disorder · United States.
Among the 318 studies in Depressive Disorder with a site in United States, this one is the 246th largest by enrollment of the 274 interventional ones, is one of 17 that started in 2017, is one of 127 with no phase, and was the 177th registered.
855 studies on the registry are indexed under Depressive Disorder; 159 are open to participants now.
This study's enrollment of 12 is below the median of 88 across 689 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →38 of the 318 studies in Depressive Disorder with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 115 Depressive Disorder studies recruiting now, 43 (37%) set no upper age limit and 66 (57%) stop at 75 or younger; 24 take children under 18; 25 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
The full table on the hub →318 studies; the count open now beside each. This study's row is marked.
First in 1988; this study’s year is marked. 17 started in 2017.
Median enrollment 87 across the 274 interventional studies, 149 across the 40 observational. Of the 258 that completed or were terminated, 98 (38%) have results posted.
79 of 318 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 2 studies filed under Depressive Disorder — fewer than ten, so there is no comparison to draw.
17 of the studies in Depressive Disorder with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07042217Soterix MedicalTranscranial Direct Current Stimulation for Depression | 2026-11-01 |
| NCT07841483Slingshot AIAI Mental Health Tool vs. Psychoeducation Control | 2026-12 |
| NCT06508450New York UniversityA Mental Health Services Engagement Program for Racial and Ethnic Minority Young Adults | 2026-12 |
| NCT05282277University of North Carolina, Chapel HillExamining the Effects of Estradiol on Neural and Molecular Response to Reward | 2026-12-31 |
| NCT05920252Ksana HealthA Digitally Assisted Risk Reduction Platform for Youth at High Risk for Suicide | 2026-12-31 |
Among the 318 studies in Depressive Disorder with a site in United States, from their registry updates:
The current study is an open feasibility trial with the aim of providing a description of the factors associated with the implementation of an iCBT platform into an existing treatment framework in a primary care setting. The trial will examine the factors surrounding implementation, such as the experience of primary care practitioners and the online supporters, the recruitment process, and attitudes towards the overall implementation of the interventions. Patients presenting to the primary care setting will be screened using standard depression and anxiety measures, and where appropriate, will be referred to an iCBT intervention for either depression or anxiety, with support from trained staff. Analyses will be conducted on outcome measures to examine changes in symptom severity as patients progress through the intervention. Patient satisfaction data will also be collected to establish patient acceptability of the intervention. [Note: Recruitment is ONLY open to patients at Ohio Family Practice Center]
iCBT is the delivery of a tailored structured cognitive and behaviour therapy based programme, with support, to individuals with mild to moderate symptoms of depression and anxiety. There is now a substantial body of research evidence that supports the efficacy and effectiveness of internet-delivered cognitive behaviour therapy for depression and anxiety. Historically, a number of iCBT interventions have been used in clinical practice in IAPT services. However, they have often suffered with poor engagement and consequently poor clinical outcomes. More recent developments in the field have produced more robust technological platforms, where content is delivered through a variety of media that enhance productivity, increase engagement and produce better clinical outcomes. The SilverCloud intervention has been demonstrated to be a clinical effective evidence-based cognitive behavioural treatment option.
Approximately 90% of primary care patients with depression have one or more visits to a primary care physician (PCP) over a 12-month period, whereas less than one-third see a mental health professional. It has been reported that individuals with an anxiety disorder are 3 to 5 times more likely to visit their primary care physician than those without, but their symptoms are often associated with physical causes. PCPs often do not have training in psychological therapies and therefore they do not feel competent to treat individuals presenting with depression or anxiety. Often these individuals are prescribed antidepressant or anti-anxiety medications.
The use of online programs to deliver CBT to people with mental health disorders is becoming increasingly popular. Internet-delivered CBT (iCBT) consists of programs designed for the treatment of specific disorders, such as depression and anxiety, which are delivered via the internet. These programs can be clinician-guided and/or self-administered interventions. Evidence suggests that iCBT can benefit individuals with anxiety and depression when offered in a service context that offers brief support from trained staff. Such iCBT interventions are widely-used in some European countries and the recommended length of treatment is generally 6 - 8 online sessions. A robust evidence base supporting the use and effectiveness of internet-delivered treatments for depression and anxiety has been established. Outcomes have been greater for those programs offering the additional feature of human support.
The current study will examine the feasibility of implementing an iCBT platform within a primary care setting. This objective can be further dismantled into several sub objectives:
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.
At least 18 years of age, Speak English, Self-report symptoms of depression or anxiety (using PHQ-9 and GAD-7 measures).
Specifically for the self-report symptoms,
participants will need to have a PHQ-9 score of 5 to 19 for the depression program or a GAD-7 score of 5 to 15 for the anxiety program.
Participants currently attending face-to-face therapy/counseling will be excluded.
Exclusion criteria
Participants who flag as a risk on the self-harm item of the PHQ-9 during routine office visit screening will not be referred to the study and will be provided treatment and/or referral services as per the clinic's standard procedure.
Space from Depression is an eight-module online CBT-based intervention for depression, composed of cognitive and behavioral components including self-monitoring and thought recording, behavioral activation, cognitive restructuring, and challenging core beliefs. Each module follows a structured format that incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other users are incorporated into the presentation of the material.
Behavioral: Space from Depression
Space from Anxiety is an eight-module online CBT-based intervention for depression, composed of cognitive and behavioral components including self-monitoring and thought recording, behavioral activation, cognitive restructuring, and challenging core beliefs. Each module follows a structured format that incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other users are incorporated into the presentation of the material.
Behavioral: Space from Anxiety
internet-delivered CBT
internet-delivered CBT
Patient health Questionnaire
The PHQ-9 is a self-report measure of depression that has been widely used in screening, primary care, and research. The PHQ-9 items reflect the diagnostic criteria for depression outlined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) (American Psychiatric Association \[APA\], 2000). Summed scores range from 0-27; larger scores reflect a greater severity of depressive symptoms. The PHQ-9 discriminated well between depressed and nondepressed individuals using the clinical cut-off of total score ≥10, with good sensitivity (88.0%) and specificity (88.0%) (Kroenke et al., 2001; R. Spitzer et al., 1999).
Time frame: At week 8
Generalized Anxiety Disorder
The GAD-7 (Spitzer, Krownke, Williams, \& Lowe, 2006) comprises 7 items measuring symptoms and severity of GAD based on the DSM-IV diagnostic criteria for GAD. The GAD-7 has good internal consistency (.89) and good convergent validity with other anxiety scales. Higher scores indicate greater severity of symptoms. The GAD-7 is increasingly used in large-scale studies as a generic measure of changes in anxiety symptomatology, using a cut-off score of 8 (Richards \& Suckling, 2009).
Time frame: At week 8
Socio-demographic Questionnaire
Collects information on the characteristics of the sample including age, gender etc.
Time frame: At baseline for screening
Work and Social Adjustment
The Work and Social Adjustment (WASA; Mundt, Marks, Shear, \& Greist, 2002) is a simple, reliable and valid measure of impaired functioning. It is a simple and reliable (α \>.75) 5-item self-report measure that provides an experiential impact of a disorder from the patient's point of view. It looks at how the disorder impairs the patient's ability to function day to day on five dimensions: work, social life, home life, private life and close relationships.
Time frame: At baseline and week 8
Satisfaction with Treatment
The Satisfaction with Treatment (SAT; Timulak \& Richards, 2012) measure contains several questions that aim to assess patient satisfaction with the iCBT intervention received. The measure consists of 2 qualitative questions and several quantitative questions, centring on what the patients liked or disliked about the iCBT intervention.
Time frame: At week 8
Attitudes towards Psychological Online Interventions
The Attitudes towards Psychological Online Interventions (APOI; Schroder et al., 2015) will be administered to patients at both pre and post intervention time points. The APOI is a brief inventory that assesses attitudes towards online interventions across four domains - scepticism and perception of risks, confidence in effectiveness, technologization threat and anonymity benefits.
Time frame: At baseline and week 8
Plan to share: No
Ran from Feb 2017 to primary completion in Feb 2018, 12 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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