Digital cognitive behavioural therapy for anxiety
| ISRCTN | ISRCTN12765810 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12765810 |
| Protocol serial number | N/A |
| Sponsor | University of Oxford |
| Funder | Big Health Inc. |
- Submission date
- 09/01/2019
- Registration date
- 11/01/2019
- Last edited
- 19/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Generalised anxiety disorder (GAD) is a condition involving excessive anxiety and worry that is difficult to control. It is estimated to affect around 5-8% of the population and can have substantial personal and economic impact. Cognitive behavioural therapy (CBT) aims to help people develop coping strategies and change unhelpful thought patterns and behaviours. CBT is the recommended treatment for GAD. However, there can be substantial barriers in accessing CBT, such as too few trained clinicians, cost, waiting lists, distance from CBT services, and stigma. A way to solve this problem is digital CBT which is CBT delivered with extensive involvement of digital means (e.g., computers, smartphones). The widespread use of smartphone technologies in our daily lives has increased interest in the use of these devices to deliver psychological therapies such as CBT. Recent evidence has shown the effectiveness of smartphone-delivered methods of reducing anxiety, but there is a lack of smartphone-based digital CBT interventions addressing GAD. This study aims to examine the effects of a new digital CBT intervention, 'Daylight', on symptoms of GAD.
Who can participate?
Adults aged 18+ with a probable diagnosis of GAD and at least moderate anxiety severity.
What does the study involve?
Participants will be randomly allocated to receive either the digital CBT programme or to a waiting list control group. Participants will be asked to complete surveys at baseline, mid-intervention (3 weeks from randomisation), post-intervention (6 weeks from randomisation), and at follow-up (10 weeks from randomisation). Waitlist control participants will receive access to the programme after completing the follow-up assessment point (after 10 weeks from randomisation).
What are the possible benefits and risks of participating?
Potential benefits of participating include the opportunity to undertake a programme based on CBT, which has been found to be an effective treatment for GAD. Participants will also be compensated in Amazon gift vouchers for their time spent completing questionnaire measures as part of the study. There are no known risks to participants taking part in this study. There is a chance participants may be fatigued or distressed by questionnaire assessments or programme content. Safety will be monitored throughout the study and participants are free to stop taking part at any time, without having to give a reason.
Where is the study run from?
This study will be conducted entirely online and is run from Nuffield Department of Clinical Neurosciences, University of Oxford.
When is the study starting and how long is it expected to run for?
The study was reviewed by the ethics committee in December 2018, recruitment will start in June 2019, and the trial is expected to end in January 2020.
Who is funding the study?
Big Health Inc.
Who is the main contact?
Chris Miller (anxiety@ndcn.ox.ac.uk)
Contact information
Public
Runway East
20 St Thomas St.
London
SE1 9RG
United Kingdom
 ORCID ID |
0000-0002-2936-7717 |
|---|---|
| Phone | +447305234684 |
| anxiety@ndcn.ox.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional parallel-group randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Efficacy of DigitaL cognitive behavioural Therapy to reduce symptoms of anxiety in adults with generalised Anxiety disorder: a randomised controlled trial |
| Study acronym | DeLTA |
| Study objectives | Current study hypothesis as of 01/05/2019: This randomised controlled trial (RCT) examines the efficacy of a novel smartphone-delivered digital Cognitive Behavioural Therapy (CBT) programme to address symptoms of Generalised Anxiety Disorder (GAD) compared with a waitlist control. Primary aim and hypothesis: The primary aim is to examine the effects of digital CBT compared to waitlist control on GAD symptom severity at post-intervention (6 weeks from randomisation). The primary hypothesis is that digital CBT will significantly reduce GAD symptom severity compared to waitlist at post-intervention. Secondary aims and hypotheses: 1. To examine the effects of digital CBT compared to waitlist control on anxiety at 10 weeks (from randomisation) follow-up. Compared to waitlist control, digital CBT is hypothesised to significantly reduce GAD symptom severity at 10 weeks follow-up. 2. To examine the effects of digital CBT compared to waitlist control at post-intervention (6 weeks from randomisation) and 10 weeks follow-up for other salient outcomes: worry, depression symptom severity, insomnia symptoms, wellbeing, and quality of life. Compared to waitlist control, digital CBT is hypothesised to significantly improve these at post-intervention and 10 weeks follow-up: worry, depression symptom severity, insomnia symptoms, wellbeing, and quality of life. Previous study hypothesis: This randomised controlled trial (RCT) examines the efficacy of a novel smartphone-delivered digital Cognitive Behavioural Therapy (CBT) programme to address symptoms of Generalised Anxiety Disorder (GAD) compared with a waitlist control. Primary aim and hypothesis: The primary aim is to examine the effects of digital CBT compared to waitlist control on GAD symptom severity at post-intervention (6 weeks from randomisation). The primary hypothesis is that digital CBT will significantly reduce GAD symptom severity compared to waitlist at post-intervention. Secondary aims and hypotheses: 1. To examine the effects of digital CBT compared to waitlist control on anxiety at 18 weeks (from randomisation) follow-up. Compared to waitlist control, digital CBT is hypothesised to significantly reduce GAD symptom severity at 18 weeks follow-up. 2. To examine the effects of digital CBT compared to waitlist control at post-intervention (6 weeks from randomisation) and 18 weeks follow-up for other salient outcomes: worry, depression symptom severity, insomnia symptoms, wellbeing, and quality of life. Compared to waitlist control, digital CBT is hypothesised to significantly improve these at post-intervention and 18 weeks follow-up: worry, depression symptom severity, insomnia symptoms, wellbeing, and quality of life. |
| Ethics approval(s) | University of Oxford Central University Research Ethics Committee, 20/12/2018, ref. R61262/RE001. |
| Health condition(s) or problem(s) studied | Generalised anxiety disorder |
| Intervention | Current interventions as of 01/05/2019: The intervention involves interactive and tailored delivery of digital CBT (cognitive behavioural therapy) for worry and anxiety via a smartphone app using the 'Daylight' programme. The Daylight programme is a voice-led experience, in which a virtual therapist guides the user through the programme. The app provides an interactive and media-rich experience and includes supportive visuals and brief animations to help to illustrate the programme content. Throughout the programme, participants will be asked to complete questions within the app about their anxiety and other aspects of experience (e.g., mood, sleep). Personalisation is built in using algorithms to tailor the intervention based on participants’ responses to questions and their progress. The Daylight programme was developed in collaboration with leading experts in the area of CBT for anxiety disorders. The content is based on evidence-based CBT techniques for the treatment of GAD, including psychoeducation, stimulus control, applied relaxation, cognitive restructuring, imaginal exposures, and progress monitoring. The programme is designed to be self-paced and includes 4 core modules, each lasting up to 20 minutes. Modules are accessed sequentially, with access to a subsequent module available on completion of the previous module. It is estimated to take approximately 6 weeks to complete the programme. Additionally, modules can be repeatedly accessed (as per the user’s preference) for repeated practice of a certain technique. The programme provides guided exercises of specific techniques, as well as personalised recommendations for how these techniques may be applied in the user’s life. In this study, participants are randomised to one of two groups. Group A will receive digital CBT and group B will be allocated to a waitlist control condition. Outcomes are assessed at 3 (mid-intervention), 6 (post-intervention), and 10 weeks (follow-up) from randomisation. Randomisation (simple randomisation with a 1:1 allocation ratio) will be conducted automatically upon enrolment and completion of the baseline survey, using the randomisation function within Qualtrics Survey Software (www.qualtrics.com). Members of the research team will be unable to influence randomisation and will be concealed from future assignments. Waitlist control participants will receive access to the digital CBT intervention after completing the follow-up assessment point (after 10 weeks from randomisation). This trial will be conducted and findings will be reported In accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines. Previous interventions: The intervention involves interactive and tailored delivery of digital CBT (cognitive behavioural therapy) for worry and anxiety via a smartphone app using the 'Daylight' programme. The Daylight programme is a voice-led experience, in which a virtual therapist guides the user through the programme. The app provides an interactive and media-rich experience and includes supportive visuals and brief animations to help to illustrate the programme content. Throughout the programme, participants will be asked to complete questions within the app about their anxiety and other aspects of experience (e.g., mood, sleep). Personalisation is built in using algorithms to tailor the intervention based on participants’ responses to questions and their progress. The Daylight programme was developed in collaboration with leading experts in the area of CBT for anxiety disorders. The content is based on evidence-based CBT techniques for the treatment of GAD, including psychoeducation, stimulus control, applied relaxation, cognitive restructuring, imaginal exposures, and progress monitoring. The programme is designed to be self-paced and includes 4 core modules, each lasting up to 20 minutes. Modules are accessed sequentially, with access to a subsequent module available on completion of the previous module. It is estimated to take approximately 6 weeks to complete the programme. Additionally, modules can be repeatedly accessed (as per the user’s preference) for repeated practice of a certain technique. The programme provides guided exercises of specific techniques, as well as personalised recommendations for how these techniques may be applied in the user’s life. In this study, participants are randomised to one of two groups. Group A will receive digital CBT and group B will be allocated to a waitlist control condition. Outcomes are assessed at 3 (mid-intervention), 6 (post-intervention), and 18 weeks (follow-up) from randomisation. Randomisation (simple randomisation with a 1:1 allocation ratio) will be conducted automatically upon enrolment and completion of the baseline survey, using the randomisation function within Qualtrics Survey Software (www.qualtrics.com). Members of the research team will be unable to influence randomisation and will be concealed from future assignments. Waitlist control participants will receive access to the digital CBT intervention after completing the follow-up assessment point (after 18 weeks from randomisation). This trial will be conducted and findings will be reported In accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Current primary outcome measure as of 08/08/2019: |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 08/08/2019: |
| Completion date | 01/06/2020 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 242 |
| Total final enrolment | 256 |
| Key inclusion criteria | Current participant inclusion criteria as of 18/09/2019: 1. Aged 18+ years. 2. A score of 10 or higher on the Generalised Anxiety Disorder questionnaire (GAD-7) indicating at least moderate GAD symptom severity. 3. Screen positive for a GAD diagnosis on a digital version of the MINI International Neuropsychiatric Interview (MINI) version 7 for DSM-5. 4. Must be either not on psychotropic medication or on a stable dose for at least 4 weeks. 5. Must not be currently receiving or have previously received CBT for anxiety in the last 12 months. Previous participant inclusion criteria: 1. Aged 18+ years 2. A score of 10 or higher on the Generalised Anxiety Disorder questionnaire (GAD-7) indicating at least moderate GAD symptom severity 3. Screen positive for a GAD diagnosis on a digital version of the MINI International Neuropsychiatric Interview (MINI) version 7 for DSM-5 4. Must be either not on psychotropic medication or on a stable dose for at least 4 weeks |
| Key exclusion criteria | 1. Past or present seizure disorder or a clinically significant head trauma (e.g. brain damage) 2. Substance use disorder 3. Serious physical health concerns necessitating surgery or with prognosis < 6 months 4. Current bipolar disorder, psychosis, or schizophrenia 5. Severe cognitive impairment that does not allow participants to consent or follow treatment instructions 6. Pregnancy |
| Date of first enrolment | 01/06/2019 |
| Date of final enrolment | 07/11/2019 |
Locations
Countries of recruitment
- United Kingdom
- England
- United States of America
Study participating centre
University of Oxford
Oxford
OX3 9DU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| IPD sharing plan | The final anonymised research data containing quantitative questionnaire data will be stored in the Oxford Research Archive (ORA; https://www.bodleian.ox.ac.uk/ora/about) at the University of Oxford for long term storage of seven years after publication or public release of the results. Information on the conditions under which data are shared is given on the ORA website. This process has received ethical approval from the University of Oxford Central University Research Ethics Committee and participants will be informed of and consent to this data storage arrangement. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2021 | 19/10/2020 | Yes | No |
| Protocol article | protocol | 23/04/2020 | 27/04/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/10/2020: Publication reference added.
27/04/2020: Publication reference added.
12/12/2019: The overall trial end date has been changed from 01/01/2020 to 01/06/2020.
11/11/2019: The recruitment end date was changed from 30/11/2019 to 07/11/2019, total final enrolment number added.
07/10/2019: The recruitment end date was changed from 01/10/2019 to 30/11/2019.
18/09/2019: The participant inclusion criteria was updated.
08/08/2019: The following changes were made:
1. The primary outcome measures were updated.
2. The secondary outcome measures were updated.
3. The plain English summary was updated.
4. The contact details were updated.
01/05/2019: The following changes were made:
1. The countries of recruitment were updated.
2. The recruitment start date was updated from 21/01/2019 to 01/06/2019.
3. The recruitment end date was updated from 31/03/2019 to 01/10/2019.
4. The overall trial end date was updated from 01/10/2019 to 01/01/2020.
5. The study hypothesis was updated.
6. The interventions were updated.
7. The plain English summary was updated.
