DepressionD-IAPTNCT03188575
Effectiveness & Cost-effectiveness of Internet-delivered Interventions for Depression and Anxiety Disorders in IAPT
A study testing SilverCloud Internet-delivered Cognitive Behavioural Therapy and Waiting List in people with Depression and Anxiety Disorders, run by Silver Cloud Health at 1 site in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression, Anxiety Disorders, Depressive Disorder
- What is being tested?
- SilverCloud Internet-delivered Cognitive Behavioural Therapy and Waiting List
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jun 2017to 30 Aug 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A score of ≥ 9 on PHQ-9 and/ or a score of ≥ 8 on GAD-7
- 18 years of age
- Suitable for an internet-delivered intervention (iCBT)
Who cannot join
- Suicidal intent/ideation
- Psychotic illness
- Currently in psychological treatment for depression and/or anxiety
- Alcohol or drug misuse
- Previous diagnosis of an organic mental health disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital IAPT: The Effectiveness & Cost-effectiveness of Internet-delivered Interventions for Depression and Anxiety Disorders in the Improving Access to Psychological Therapies Programme
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Depression, Anxiety Disorders, Depressive Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Phobic Disorders
- Being tested
- SilverCloud Internet-delivered Cognitive Behavioural Therapy, Waiting List
- Medical subject headings
- Depression, Anxiety Disorders, Depressive Disorder, Generalized Anxiety Disorder, Phobia, Social, Phobic Disorders, Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilverCloud Internet-delivered Cognitive Behavioural TherapyBehavioural
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).
Waiting ListOther
8 week waiting list period.
| Study group | Role | What they receive |
|---|---|---|
| iCBT for Depression and Anxiety | Experimental | SilverCloud Internet-Delivered Cognitive Behavioural Therapy Receives: Behavioral: SilverCloud Internet-delivered Cognitive Behavioural Therapy |
| Waiting List | Active comparator | Waiting list control Receives: Other: Waiting List |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression symptoms
Measured by the 9 item Patient Health Questionnaire (PHQ-9)
Measured: 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)
Measured: 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
Secondary outcomes (18)
Work and Social Adjustment
Measured using the Work and Social Adjustment scale (WSAS)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: Baseline and 8 weeks
Rumination
Measured using the Positive Beliefs about Depressive Rumination scale (PBRS-A)
Measured: Baseline and 8 weeks
Therapeutic Expectancy
Measured using the Expectancy/Credibility scale (TEQ)
Measured: Baseline, 4 weeks and 8 weeks.
CBT Skills Usage
Measured using the Frequency of Actions and Thoughts scale (FATS)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: During the patient recruitment period.
M.I.N.I. International Neuropsychiatric Interview
Used to determine a diagnosis of depression and/or anxiety (MINI)
Measured: Baseline and 3-month follow-up
Patient Experience/Satisfaction
Measured using the Patient Experience Questionnaire (PEQ)
Measured: Post treatment (up to 8 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start15 Jun 2017
- Primary completion25 Jul 2019 (estimated)
- Study completion30 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silver Cloud Health
- Sponsor type
- University, hospital or other
- Collaborators
- Berkshire Healthcare NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Derek Richards, PhD, Study director, SilverCloud HealthSarah Sollesse, MSc, Principal investigator, Berkshire Healthcare NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188575
- Sponsor's protocol ID
- D-IAPT
- Acronym
- D-IAPT
- Status last verified
- Sep 2018
- First submitted
- 8 Jun 2017
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Available on request from the PI
Publications
Richards D, Timulak L, O'Brien E, Hayes C, Vigano N, Sharry J, Doherty G. A randomized controlled trial of an internet-delivered treatment: Its potential as a low-intensity community intervention for adults with symptoms of depression. Behav Res Ther. 2015 Dec;75:20-31. doi: 10.1016/j.brat.2015.10.005. Epub 2015 Oct 21.
PubMed 26523885Richards D, Duffy D, Blackburn B, Earley C, Enrique A, Palacios J, Franklin M, Clarke G, Sollesse S, Connell S, Timulak L. Digital IAPT: the effectiveness & cost-effectiveness of internet-delivered interventions for depression and anxiety disorders in the Improving Access to Psychological Therapies programme: study protocol for a randomised control trial. BMC Psychiatry. 2018 Mar 2;18(1):59. doi: 10.1186/s12888-018-1639-5.
PubMed 29499675
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital IAPT: The Effectiveness & Cost-effectiveness of Internet-delivered Interventions for Depression and Anxiety Disorders in the Improving Access to Psychological Therapies Programme
- ClinicalTrials.gov ID
- NCT03188575
- Acronym / sponsor ID
- D-IAPT / D-IAPT
- Conditions
- Depression, Anxiety Disorders, Depressive Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Phobic Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Silver Cloud HealthUniversity, hospital or other
- Collaborators
- Berkshire Healthcare NHS Foundation Trust
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 25 Jul 2019 (estimated)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 15 Jun 2017 (actual)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iCBT for Depression and Anxiety | Experimental | Behavioral: SilverCloud Internet-delivered Cognitive Behavioural TherapySilverCloud Internet-Delivered Cognitive Behavioural Therapy |
| Waiting List | Active comparator | Other: Waiting ListWaiting list control |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A score of ≥ 9 on PHQ-9 and/ or a score of ≥ 8 on GAD-7
- 18 years of age
- Suitable for an internet-delivered intervention (iCBT)
Key exclusion criteria (5 listed)
- Suicidal intent/ideation
- Psychotic illness
- Currently in psychological treatment for depression and/or anxiety
- Alcohol or drug misuse
- Previous diagnosis of an organic mental health disorder
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 |
|---|---|---|
| SilverCloud Internet-delivered Cognitive Behavioural TherapySilverCloud 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). | Behavioural | iCBT for Depression and Anxiety |
| Waiting List8 week waiting list period. | Other | Waiting List |
Primary outcome
Change in Depression symptoms
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
Measured by the 9 item Patient Health Questionnaire (PHQ-9)
Change in Anxiety symptoms
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
Measured by the 7 item Generalised Anxiety Disorder inventory (GAD-7)
18 secondary outcomes
Work and Social Adjustment
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
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
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
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
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
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
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
Time frame: baseline, 8 weeks, 6 month follow-up, 9 month follow-up and 12 month follow-up
Emotion Regulation
Time frame: Baseline and 8 weeks
Rumination
Time frame: Baseline and 8 weeks
Therapeutic Expectancy
Time frame: Baseline, 4 weeks and 8 weeks.
CBT Skills Usage
Time frame: 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up
Therapist Behaviours
Time frame: Continuous during treatment after each session for 8 weeks
Therapeutic Alliance for patients
Time frame: Continuous during treatment after each session for 8 weeks
Therapeutic Alliance for clinicians
Time frame: Continuous during treatment after each session for 8 weeks
Therapeutic Alliance for clinicians
Time frame: During the patient recruitment period.
M.I.N.I. International Neuropsychiatric Interview
Time frame: Baseline and 3-month follow-up
Patient Experience/Satisfaction
Time frame: Post treatment (up to 8 weeks).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Background: PubMed 26523885Richards D, Timulak L, O'Brien E, Hayes C, Vigano N, Sharry J, Doherty G. A randomized controlled trial of an internet-delivered treatment: Its potential as a low-intensity community intervention for adults with symptoms of depression. Behav Res Ther. 2015 Dec;75:20-31. doi: 10.1016/j.brat.2015.10.005. Epub 2015 Oct 21.
- Derived from this study: PubMed 29499675Richards D, Duffy D, Blackburn B, Earley C, Enrique A, Palacios J, Franklin M, Clarke G, Sollesse S, Connell S, Timulak L. Digital IAPT: the effectiveness & cost-effectiveness of internet-delivered interventions for depression and anxiety disorders in the Improving Access to Psychological Therapies programme: study protocol for a randomised control trial. BMC Psychiatry. 2018 Mar 2;18(1):59. doi: 10.1186/s12888-018-1639-5.
- Individual participant dataSharing planned: No. Available on request from the PI
Related trials for Depression
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
Recruiting
Cancer Pain Management Using a Web-based Intervention
Cancer of Breast, Depressive Symptoms
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
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
Sarah Sollesse, MSc principal investigator
Berkshire Healthcare NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SilverCloud Internet-delivered Cognitive Behavioural Therapy and Waiting List in people with Depression and Anxiety Disorders, run by Silver Cloud Health at 1 site in United Kingdom.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 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 Kingdom. 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?
Results are not available in the source record.
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 Depression symptoms (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). The study lists 2 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 NCT03188575, which also lists 2 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 10 Sep 2018.