Internet-delivered interventions for people with depression and anxiety in IAPT services
| ISRCTN | ISRCTN91967124 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91967124 |
| Secondary identifying numbers | 214669 |
- Submission date
- 16/05/2017
- Registration date
- 06/06/2017
- Last edited
- 14/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
SilverCloud Health
One Stevens Street Upper
Dublin
8
Ireland
 ORCID ID |
0000-0003-0871-4078 |
|---|
Study information
| Study design | Single-blind parallel-group randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | D-IAPT |
| Study objectives | 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(s) | NHS North-West Haydock Research Committee, 16/05/2017, ref: 17/NW/0311 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 30/09/2016 |
| Completion date | 01/08/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 360 |
| Total final enrolment | 361 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 28/06/2017 |
| Date of final enrolment | 30/04/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Fitzwilliam House
Skimped Hill Lane
Bracknell
RG12 1BQ
United Kingdom
Sponsor information
Other
One Stevens Street Upper
Dublin
8
Ireland
| Phone | +353 15 549 767 |
|---|---|
| info@silvercloudhealth.com | |
| Website | www.silvercloudhealth.com |
"ROR" |
https://ror.org/05319p535 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Derek Richards. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 02/03/2018 | Yes | No | |
| Results article | results | 01/12/2020 | 01/09/2020 | Yes | No |
| Other publications | assessment of psychometric measures | 09/04/2021 | 14/07/2021 | Yes | No |
| Preprint results | non-peer-reviewed dropout results | 01/08/2021 | 14/07/2021 | No | No |
| Results article | nested longitudinal qualitative results | 28/05/2021 | 14/07/2021 | Yes | No |
| Results article | secondary analysis | 18/01/2021 | 14/07/2021 | Yes | No |
| Results article | Cost-Effectiveness | 01/06/2022 | 01/07/2022 | Yes | No |
| Results article | Durability of treatment effects | 25/04/2022 | 01/07/2022 | Yes | No |
| Results article | The relationship between posttherapeutic Cognitive Behavior Therapy skills usage and follow-up outcomes of internet-delivered Cognitive Behavior Therapy | 21/06/2022 | 01/07/2022 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | secondary analysis | 12/07/2023 | 14/08/2024 | Yes | No |
Editorial Notes
14/08/2024: Publication reference added.
01/07/2022: Publication references added.
14/07/2021: Publication references added.
01/09/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
11/06/2019: The following changes were made:
1. The recruitment start date was updated from 25/07/2017 to 28/06/2017.
2. The recruitment end date was updated from 24/07/2018 to 30/04/2018.
13/09/2018: The overall trial end date was updated from 01/09/2018 to 01/08/2019 and the intention to publish date was updated from 20/08/2018 to 31/12/2019.
08/03/2018: Publication reference added.
