An interventional study of SilverCloud Internet-delivered Cognitive Behavioural Therapy and Waiting List in Depression, Anxiety Disorders and Depressive Disorder, sponsored by Silver Cloud Health. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-09-10.
Sponsored by Silver Cloud Health · Not applicable, Interventional, and Treatment
Among 282 studies in Depression with a site in United Kingdom — 49 open to participants now, 52 under way, 6 of them phase 3. Depression · United Kingdom.
Among the 282 studies in Depression with a site in United Kingdom, this one is the 30th largest by enrollment of the 232 interventional ones, is one of 11 that started in 2017, is one of 180 with no phase, and was the 93rd registered.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 384 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →49 of the 282 studies in Depression with a site in United Kingdom 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 to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →282 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 11 started in 2017.
Median enrollment 62 across the 232 interventional studies, 185 across the 50 observational. Of the 186 that completed or were terminated, 19 (10%) have results posted.
39 of 282 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.
17 of the studies in Depression with a site in United Kingdom that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06793397Phase 3Cybin IRL LimitedA Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder | 2027-06-07 |
| NCT06963021Phase 3Neurocrine BiosciencesNBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) | 2027-07 |
| NCT07599930King's College LondonImpact of a Novel Functional Snack on Perimenopausal Symptoms and Well-being | 2026-12 |
| NCT07398365University of EdinburghMedical Phenotyping of NHS General Adult Psychiatry (GAP) Inpatients | 2026-12-31 |
| NCT07424781University of OxfordFluoxetine on Emotional Experience (FLEX) Study | 2026-12-31 |
Among the 282 studies in Depression with a site in United Kingdom, from their registry updates:
Depression and anxiety are common mental health problems. There are effective treatments for depression and anxiety and one of these is talking therapies using cognitive behaviour therapy (CBT). In recent years CBT has been transferred to online delivery methods and these interventions have proven successful for people being treated with symptoms of depression and anxiety.
The current study will utilise a randomised controlled trial design, where the majority (n=240) of participants will be allocated to the immediate treatment (internet-delivered CBT for either depression or anxiety), and a smaller number (n=120) will be allocated to a waiting list. The waiting list group will receive treatment after an eight week wait. This design helps us to understand that any changes in symptoms in the treatment group will be likely due to the treatment they received compared to the waiting list.
A sample size of 360 participants is proposed and has been adjusted to ameliorate against patient dropout. Follow-up and maintenance of any positive changes in symptoms is very important in CBT for depression and anxiety, simply because some people can have a relapse of symptoms. We will therefore follow-up the treatment group for 3, 6, 9 and 12 months to assess maintenance of positive gains from treatment.
The study also seeks to investigate the cost effectiveness of the treatments.
A CONSORT compliant single-blinded, parallel-groups, randomised controlled trial design will be used to examine the efficacy of internet-delivered interventions for depression and anxiety disorders against a waiting list control group. To be eligible participants will be screened and will need to score ≥ 9 on the PHQ-9 and / or ≥ 8 on the GAD-7. To establish a formal diagnosis of depression or anxiety, eligible participants will complete the M.I.N.I. neuropsychiatric interview and thereafter will be randomised to either an immediate treatment group or a waiting list group. Randomisation will follow a 2:1 ratio. The immediate treatment will complete a M.I.N.I. neuropsychiatric interview at 3-months follow-up from baseline. The treatment group will be followed up at 6-, 9- and 12-months post-treatment. The waiting list control group will be enrolled into the treatment once the immediate treatment group will have completed. The waiting list will complete baseline screening and research measures at baseline and similarly complete research measures at the end of the waiting period (8-weeks).
In addition, a nested study examining the mediators and moderators for change and maintenance of change is included. Specific and general mechanisms of change will be explored to include positive beliefs about repetitive negative thinking, therapeutic skills usage and therapist behaviours. General mediators including the therapeutic alliance and participant's expectancy / credibility and will be examined. The study protocol, information on the study, informed consent will be submitted for approval by the NHS England Research Ethics Committee and Health Research Authority approval for the study will be sought.
The study aims to evaluate the effectiveness and cost effectiveness of internet-delivered interventions for symptoms of depression and anxiety disorders in IAPT.
Individuals who contact Berkshire Healthcare NHS Foundation Trust to access IAPT psychological services will be eligible to participate. Recruitment will begin in May 2017 and will continue for 6 months until the numbers are reached or exceeded.
Using G-Power to calculate our sample size and based on a moderate between group effect size of d=0.5 with a power of 80% and a 2:1 randomisation procedure into immediate treatment for depression and/or anxiety and a corresponding waiting list control group returned a total sample of 288. Adding a 25% uplift to ameliorate against attrition gave a total sample size of 360. Therefore for depression a total sample of 120 in the treatment group and a corresponding 60 in the control group and the same ratio for anxiety disorders. The 2:1 randomisation procedure was implemented to reduce the concern of having many people waiting for treatment after presenting to the IAPT service.
PWP clinicians who are involved in the study trial as supporters to participants will be invited to take part in the research, to complete post-review alliance measures online, complete post review therapist behaviours checklist and volunteer for a semi-structured interview to collect qualitative data on therapeutic alliance and therapist behaviours.
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:
SilverCloud Internet-Delivered Cognitive Behavioural Therapy
Behavioral: SilverCloud Internet-delivered Cognitive Behavioural Therapy
Waiting list control
Other: Waiting List
SilverCloud Health is a leading provider of online therapeutic solutions to support and promote positive behavior change and mental wellness. SilverCloud delivers interventions for all of the anxiety disorders (panic disorder, social anxiety, phobias, GAD, health anxiety, OCD), depression and also comorbid depression and anxiety. The programs for the treatment of depression and anxiety employ several innovative engagement strategies for improving the user experience. These are divided into several categories: personal, interactive, supportive, and social. Research on the SilverCloud interventions has yielded significant clinical outcomes (Richards et al., 2015).
8 week waiting list period.
Change in Depression symptoms
Measured by the 9 item Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up
Change in Anxiety symptoms
Measured by the 7 item Generalised Anxiety Disorder inventory (GAD-7)
Time frame: Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up
Work and Social Adjustment
Measured using the Work and Social Adjustment scale (WSAS)
Time frame: Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up
Social Anxiety
Measured using the Social Phobia Inventory (SPIN)
Time frame: Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up
Health Anxiety
Measured using the Short Health Anxiety Inventory (SHAI)
Time frame: Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up
Panic
Measured using the Panic Disorder Severity Scale (PDSS)
Time frame: Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up
Generalised Anxiety Symptoms
Measured using the Penn State Worry Questionnaire (PSWQ)
Time frame: Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up
Quality of life
Measured using the EQ5D5L
Time frame: baseline, 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up
Quality of life for users of mental health services
Measured using the Re-QOL
Time frame: baseline, 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up
Client service usage
Measured using the Client Services Receipt Inventory (CSRI)
Time frame: baseline, 8 weeks, 6 month follow-up, 9 month follow-up and 12 month follow-up
Emotion Regulation
Measured using the Emotion Regulation Questionnaire (ERQ)
Time frame: Baseline and 8 weeks
Rumination
Measured using the Positive Beliefs about Depressive Rumination scale (PBRS-A)
Time frame: Baseline and 8 weeks
Therapeutic Expectancy
Measured using the Expectancy/Credibility scale (TEQ)
Time frame: Baseline, 4 weeks and 8 weeks.
CBT Skills Usage
Measured using the Frequency of Actions and Thoughts scale (FATS)
Time frame: 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up
Therapist Behaviours
Measured using the Therapist Behaviours Checklist (TBCL)
Time frame: Continuous during treatment after each session for 8 weeks
Therapeutic Alliance for patients
Measured using the Scale to Assess Therapeutic Relationships - Patient Version (STAR-P)
Time frame: Continuous during treatment after each session for 8 weeks
Therapeutic Alliance for clinicians
Measured using the Scale to Assess Therapeutic Relationships - Clinician version (STAR-C)
Time frame: Continuous during treatment after each session for 8 weeks
Therapeutic Alliance for clinicians
Semi-structured interview will be employed to assess qualitatively clinicians experience of the therapeutic relationship online.
Time frame: During the patient recruitment period.
M.I.N.I. International Neuropsychiatric Interview
Used to determine a diagnosis of depression and/or anxiety (MINI)
Time frame: Baseline and 3-month follow-up
Patient Experience/Satisfaction
Measured using the Patient Experience Questionnaire (PEQ)
Time frame: Post treatment (up to 8 weeks).
Plan to share: No — Available on request from the PI
Started Jun 2017 (actual). Primary completion is estimated for Jul 2019, 25 months after the start.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 25 months is above that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Silver Cloud Health