Condition category
Mental and Behavioural Disorders
Date applied
16/05/2017
Date assigned
06/06/2017
Last edited
06/06/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Depression and anxiety are common mental health problems. There are effective treatments for depression and anxiety and one of these is talking therapies using a technique called cognitive behavioural therapy (CBT). CBT is a type of therapy that helps people to change the way they think and behave. In recent years internet-delivered CBT has emerged as an alternative to face-to-face psychological services, and it has proven to be successful in treating people with depression and anxiety. SilverCloud is an innovative online behavioral health and wellness e-therapy delivery platform. It enables healthcare organisations to deliver a broad range of highly engaging and interactive online behavioral and long-term illness content, programs and support to their clients and patients. SilverCloud is proven to improve clinical/patient outcomes, dramatically reduce the cost of behavioral health delivery/support, increase scalability/reach and increase access. The aim of this study is to evaluate the effectiveness and cost-effectiveness of this program in improving the symptoms of depression and anxiety disorders.

Who can participate?
Adults who are suffering from depression or anxiety.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive immediate treatment with internet-delivered CBT for either depression or anxiety. Those in the second group receive the treatment after an eight week wait. At the start of the study and then after three, six, nine and twelve months, participants in both groups complete a range of questionnaires to assess their mental wellbeing, to find out if they have benefited from the treatment.

What are the possible benefits and risks of participating?
Participants may benefit from receiving the treatment, which could help improve their symptoms. There are no notable risks involved with participating.

Where is the study run from?
Talking Therapies IAPT (UK)

When is the study starting and how long is it expected to run for?
September 2016 to September 2018

Who is funding the study?
SilverCloud Health (Ireland)

Who is the main contact?
Dr Derek Richards

Trial website

Contact information

Type

Scientific

Primary contact

Dr Derek Richards

ORCID ID

http://orcid.org/0000-0003-0871-4078

Contact details

SilverCloud Health
One Stevens Street Upper
Dublin
8
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

214669

Study information

Scientific title

Digital IAPT: The effectiveness & cost-effectiveness of internet-delivered interventions for depression and anxiety disorders in the Improving Access to Psychological Therapies programme

Acronym

D-IAPT

Study hypothesis

The aim of this study is to evaluate the effectiveness and cost-effectiveness of internet-delivered interventions for symptoms of depression and anxiety disorders.

Ethics approval

NHS North-West Haydock Research Committee, 16/05/2017, ref: 17/NW/0311

Study design

Single-blind parallel-group randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Depression and anxiety disorders

Intervention

Post diagnostic assessment participants will be randomised to either the immediate treatment (depression or anxiety) or a waiting list control group using random permuted blocks using block sizes of 9 and including stratification within a 2:1 ratio between treatment groups – depression and anxiety - and the waiting list control group.

Immediate treatment group: Participants will be assigned to either the Space from Deopression or the Space from Anxiety interventions and they will be encouraged to use the intervention over 8 weeks and they will receive up to 6 online reviews from their clinician supporter over that time. Data will be collected at baseline, continuously at each session, at 8 weeks and at 3, 6, 9 and 12 months follow-up.

Space from Depression
The online intervention ‘Space from Depression’ is a seven-module online CBT-based intervention for depression, delivered on a Web 2.0 platform using media-rich interactive content. Programme content is delivered in a non-linear fashion. Each module takes roughly 1 hour to complete and it is recommended one module be completed per week. The structure and content of the programme modules follow evidence-based CBT principles. The treatment is comprised of established cognitive and behavioural components including self-monitoring, self-control desensitization, gradual stimulus control, thought recording, behavioural activation, cognitive restructuring, relaxation training and challenging core beliefs. Each module is structured to incorporate 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. The intervention follows NICE guidelines for the treatment of depression and the intervention has been tested and proved efficacious (National Institute for Clinical Excellence, 2009; National Institute for Health and Clinical Excellence, 2006; D. Richards, Timulak, et al., 2015)

Space from Anxiety
Space from Anxiety is an eight-module online CBT-based intervention for Anxiety. The structure and content of the program modules follow established evidence-based principles of CBT for the treatment Anxiety. The treatment comprises cognitive, emotional, and behavioral components that include self-monitoring, relaxation training, cognitive restructuring, and worry outcome monitoring. The treatment is delivered on a Web 2.0 platform using media-rich interactive content. The getting started module for the core Anxiety programme introduces the user to the cycle of anxiety and the emotional, cognitive and behavioural aspects of anxiety. The goal of the intervention is to help people with anxiety as a primary disorder manages their thoughts, emotions and behaviours to help them alleviate their symptoms. The intervention follows NICE guidelines for the treatment of anxiety and the intervention has been tested and proved efficacious (National Institute for Clinical Excellence, 2009; National Institute for Health and Clinical Excellence, 2006; D. Richards, Timulak, et al., 2015).

Waiting list control group: Those in the waiting list group will be given access to the programme after an 8 week waiting period post randomisation. This group will receive assessments at baseline, and before they begin treatment after the 8 week waiting period.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Depression is assessed using the Patient Health Questionnaire-9 (PHQ-9) at baseline, throughout treatment, at 8 weeks and at 3, 6, 9 and 12 months follow-up
2. Anxiety is assessed using the Generalized Anxiety Disorder-7 (GAD-7) at baseline, throughout treatment, at 8 weeks and at 3, 6, 9 and 12 months follow-up

Secondary outcome measures

1. Diagnosis of depression or anxiety for research purposes will be established using the M.I.N.I. International Neuropsychiatric Interview 7.0 (MINI) at baseline and 3 months follow-up
2. Work and social adjustment is assessed using the Work and Social Adjustment (WASA)at baseline, throughout treatment, at 8 weeks and at 3, 6, 9 and 12 months follow-up
3. Social Anxiety is assessed using the Social Phobia Inventory (SPIN)at baseline, throughout treatment, at 8 weeks and at 3, 6, 9 and 12 months follow-up
4. Health Anxiety is assessed using the Short Health Anxiety Inventory (HAI) at baseline, throughout treatment, at 8 weeks and at 3, 6, 9 and 12 months follow-up
5. Panic is assessed using the Panic Disorder Severity Scale-Self Report (PDSS-SR)at baseline, throughout treatment, at 8 weeks and at 3, 6, 9 and 12 months follow-up
6. GAD symptoms are assessed using the Penn State Worry Questionnaire (PSWQ) at baseline, throughout treatment, at 8 weeks and at 3, 6, 9 and 12 months follow-up
7. Quality of life for users of mental health services is assessed using the Recovering Quality of Life scale (ReQoL)at baseline, throughout treatment, at 8 weeks and at 3, 6, 9 and 12 months follow-up
8. Client service usage is assessed using the Client Service Receipt Inventory (CSRI)at baseline, throughout treatment, at 8 weeks and at 6, 9 and 12 months follow-up
9. Emotion regulation is assessed using the Emotion Regulation Questionnaire (ERQ) at baseline and at 8 weeks
10. Rumination is assessed using the Positive Beliefs about Depressive Rumination Scale – adapted (PBRS-A) version at baseline and 8 weeks
11. Therapeutic Expectancy is assessed using the Expectancy and Credibility Questionnaire (ECQ) for the treatment group at baseline, 4 and 8 weeks
12. Therapeutic Alliance for patients is assessed using the Scale to Assess Therapeutic Relationships – Patient Version (STAR-P) throughout treatment
13. Therapeutic Alliance for clinicians is assessed using the Scale to Assess Therapeutic Relationships – Clinician Version (STAR-C) each time they review a patient and using semi-structured interview with clinicians.
14. CBT Skills is assessed using the Frequency of Actions and Thoughts Scale (FATS) at 3, 6, 9 and 12 months follow-up
15. Therapist behaviours are assessed by clinicians using the therapist behaviours checklist throughout treatment

Overall trial start date

30/09/2016

Overall trial end date

01/09/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. A score of ≥ 9 on PHQ-9 and/ or a score of ≥ 8 on GAD-7
2. 18 years of age
3. Suitable for an internet-delivered intervention (iCBT)
4. Users of the Berkshire NHS Trust IAPT Talking Therapies Step 2 services

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

360

Participant exclusion criteria

1. Suicidal intent/ideation
2. Psychotic illness
3. Currently in psychological treatment for depression and/or anxiety
4. Alcohol or drug misuse
5. Previous diagnosis of an organic mental health disorder

Recruitment start date

25/07/2017

Recruitment end date

24/07/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Talking Therapies IAPT
Berkshire Healthcare NHS Foundation Trust Fitzwilliam House Skimped Hill Lane
Bracknell
RG12 1BQ
United Kingdom

Sponsor information

Organisation

SilverCloud Health

Sponsor details

One Stevens Street Upper
Dublin
8
Ireland
+353 15 549 767
info@silvercloudhealth.com

Sponsor type

Other

Website

www.silvercloudhealth.com

Funders

Funder type

Other

Funder name

SilverCloud Health

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The main outcomes form the trial and the cost effectiveness analysis will be prepared for and submitted for publication in a suitable peer reviewed publication.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Derek Richards.

Intention to publish date

20/08/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes