Social AnxietyNCT05858294
The Safety, Acceptability and Efficacy of Alena
A study testing Cognitive Behavioral Therapy programme in people with Social Anxiety and Social Anxiety Disorder, run by Aya Technologies Limited at 1 site in United Kingdom.
Trial summary
The present study is a randomised controlled trial that seeks to investigate the safety, acceptability and efficacy and safety of the Alena CBT programme as a treatment for social anxiety disorder. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Social Anxiety, Social Anxiety Disorder, Social Anxiety Disorder (Social Phobia)
- What is being tested?
- Cognitive Behavioral Therapy programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Oct 2022to 18 Dec 2022
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female
- aged between 18 and 35 years old (inclusive)
- located in the UK
- fluent in English
- comfortable taking part in a study that included deception (due to the nature of the cognitive assessments)
- had an iPhone and daily access to an internet connection
- scored over 30 on the Social Phobia Inventory (SPIN; indicating at least moderate social anxiety).
Who cannot join
- currently undergoing any mental health therapy
- changed the usual mental health medication or dosage within the past eight weeks
- scored eight or above on the Alcohol Use Disorders Identification Test for consumption (AUDIT-C; indicating higher risk of alcohol dependence)
- scored two or above on the adapted drug questions (indicating higher risk of drug dependence)
- had previously participated in scientific studies or user research undertaken by Alena
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety, Acceptability and Efficacy of Alena, a Modularized CBT-based Mobile App Intervention for Social Anxiety: a Randomised Controlled Trial
The present study is a randomised controlled trial that seeks to investigate the safety, acceptability and efficacy and safety of the Alena CBT programme as a treatment for social anxiety disorder.
Read the detailed description
This is a 6-week web-based parallel-group unblinded randomised controlled trial with a 4-week intervention period and a 2-week follow-up post intervention. Participants are randomly allocated to receive access to the Alena CBT programme or to a wait list control group, in a 1:1 ratio. The programme consists of CBT-based therapy for social anxiety based on the Clark and Wells model.
- Being tested
- Cognitive Behavioral Therapy programme
- Keywords
- RCT, CBT
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy programmeBehavioural
This mobile application comprised CBT-based therapy for social anxiety based on the Clark and Wells model
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy program | Experimental | Access to the "Alena" CBT-based therapy programme for 4 weeks. Each of the four therapy modules gradually became available on a weekly basis until all four were available in the final intervention week. Participants were instructed to complete one module per week. Each therapy module consisted of psychoeducational content, guided psychological reflection and perspective-taking exercises, and, where appropriate, skills training exercises such as attention training, public speaking, and exposure experiments to be completed in real life. Receives: Behavioral: Cognitive Behavioral Therapy programme |
| Waitlist control | No intervention | Waitlist control. Participants in this arm were given access to the CBT content at the end of the 4-week trial period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaires assessing negative effects from using the app and adverse health events
The Intervention group was asked "Have you experienced any negative effects from using the Alena app? This could be a physical or emotional effect that you believe you have experienced as a result of using the app and/or engaging in the app therapy." Both groups were asked: "Have you experienced any new, serious negative health effects in the past week? This includes having to see your GP for a new reason, going to hospital, or being otherwise very unwell in terms of your physical or mental health." If participants responded positively to either question, they were prompted for additional details and to rate the severity of the experience.
Measured: Week 4 (primary endpoint)
Questionnaires assessing negative effects from using the app and adverse health events
The Intervention group was asked "Have you experienced any negative effects from using the Alena app? This could be a physical or emotional effect that you believe you have experienced as a result of using the app and/or engaging in the app therapy." Both groups were asked: "Have you experienced any new, serious negative health effects in the past week? This includes having to see your GP for a new reason, going to hospital, or being otherwise very unwell in terms of your physical or mental health." If participants responded positively to either question, they were prompted for additional details and to rate the severity of the experience.
Measured: Week 6 (2-week follow-up post-intervention)
Questionnaire assessing satisfaction, helpfulness and ease of use
Participants were asked how satisfied they were with the app overall (Likert rating scale from very dissatisfied to very satisfied); how helpful they found the app (Likert ratings from very unhelpful to very helpful); how likely they would be to recommend the app (Likert ratings from very unlikely to very likely); how easy they found using the app (Likert ratings from very difficult to very easy); whether they got to the end of the weekly exercise (yes/no), and what got in the way of completing the exercises, with options provided.
Measured: Week 4 (primary endpoint)
Questionnaire assessing satisfaction, helpfulness and ease of use
Participants were asked how satisfied they were with the app overall (Likert rating scale from very dissatisfied to very satisfied); how helpful they found the app (Likert ratings from very unhelpful to very helpful); how likely they would be to recommend the app (Likert ratings from very unlikely to very likely); how easy they found using the app (Likert ratings from very difficult to very easy); whether they got to the end of the weekly exercise (yes/no), and what got in the way of completing the exercises, with options provided.
Measured: Week 6 (2-week follow-up post-intervention)
Secondary outcomes (4)
Social phobia inventory (SPIN)
The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear, avoidance and physiological components. Total score ranging from 0 to 68, with higher scores indicating a worse outcome.
Measured: Week 4 (primary endpoint)
Social phobia inventory (SPIN)
The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear, avoidance and physiological components. Total score ranging from 0 to 68, with higher scores indicating a worse outcome.
Measured: Week 6 (2-week follow-up post-intervention)
Work and Social Adjustment Scale (WSAS)
The WSAS measures the extent to which the respondent's problem impairs their ability to carry out day-to-day activities, such as work, home management and social leisure activities. Total score ranging from 0 to 40, with higher scores indicating higher impairment
Measured: Week 4 (primary endpoint)
Work and Social Adjustment Scale (WSAS)
The WSAS measures the extent to which the respondent's problem impairs their ability to carry out day-to-day activities, such as work, home management and social leisure activities. Total score ranging from 0 to 40, with higher scores indicating higher impairment
Measured: Week 6 (2-week follow-up post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start31 Oct 2022
- Primary completion4 Dec 2022
- Study completion18 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Social AnxietyStudies 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
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aya Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mandana Ahmadi, PhD, Principal investigator, Aya Technologies Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858294
- Sponsor's protocol ID
- Alena CBT RCT 2022
- Status last verified
- May 2023
- First submitted
- 21 Apr 2023
- Last updated
- 15 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Connor KM, Davidson JR, Churchill LE, Sherwood A, Foa E, Weisler RH. Psychometric properties of the Social Phobia Inventory (SPIN). New self-rating scale. Br J Psychiatry. 2000 Apr;176:379-86. doi: 10.1192/bjp.176.4.379.
PubMed 10827888Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
PubMed 11983645Garvert MM, McFadyen J, Linke S, McCloud T, Meyer SS, Sobanska S, Sharp PB, Long A, Huys QJM, Ahmadi M. Safety and Efficacy of Modular Digital Psychotherapy for Social Anxiety: Randomized Controlled Trial. J Med Internet Res. 2025 Apr 10;27:e64138. doi: 10.2196/64138.
PubMed 40208666
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety, Acceptability and Efficacy of Alena, a Modularized CBT-based Mobile App Intervention for Social Anxiety: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05858294
- Acronym / sponsor ID
- Alena CBT RCT 2022
- Keywords
- RCT, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Aya Technologies LimitedIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 4 Dec 2022 (actual)
- Study completion
- 18 Dec 2022 (actual)
- First posted
- 15 May 2023 (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.
The present study is a randomised controlled trial that seeks to investigate the safety, acceptability and efficacy and safety of the Alena CBT programme as a treatment for social anxiety disorder.
Detailed description
This is a 6-week web-based parallel-group unblinded randomised controlled trial with a 4-week intervention period and a 2-week follow-up post intervention. Participants are randomly allocated to receive access to the Alena CBT programme or to a wait list control group, in a 1:1 ratio. The programme consists of CBT-based therapy for social anxiety based on the Clark and Wells model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy program | Experimental | Behavioral: Cognitive Behavioral Therapy programmeAccess to the "Alena" CBT-based therapy programme for 4 weeks. Each of the four therapy modules gradually became available on a weekly basis until all four were available in the final intervention week. Participants were instructed to complete one module per week. Each therapy module consisted of psychoeducational content, guided psychological reflection and perspective-taking exercises, and, where appropriate, skills training exercises such as attention training, public speaking, and exposure experiments to be completed in real life. |
| Waitlist control | No intervention | –Waitlist control. Participants in this arm were given access to the CBT content at the end of the 4-week trial period. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- female
- aged between 18 and 35 years old (inclusive)
- located in the UK
- fluent in English
- comfortable taking part in a study that included deception (due to the nature of the cognitive assessments)
Key exclusion criteria (5 listed)
- currently undergoing any mental health therapy
- changed the usual mental health medication or dosage within the past eight weeks
- scored eight or above on the Alcohol Use Disorders Identification Test for consumption (AUDIT-C; indicating higher risk of alcohol dependence)
- scored two or above on the adapted drug questions (indicating higher risk of drug dependence)
- had previously participated in scientific studies or user research undertaken by Alena
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 |
|---|---|---|
| Cognitive Behavioral Therapy programmeThis mobile application comprised CBT-based therapy for social anxiety based on the Clark and Wells model | Behavioural | Cognitive Behavioral Therapy program |
Primary outcome
Questionnaires assessing negative effects from using the app and adverse health events
Time frame: Week 4 (primary endpoint)
The Intervention group was asked "Have you experienced any negative effects from using the Alena app? This could be a physical or emotional effect that you believe you have experienced as a result of using the app and/or engaging in the app therapy." Both groups were asked: "Have you experienced any new, serious negative health effects in the past week? This includes having to see your GP for a new reason, going to hospital, or being otherwise very unwell in terms of your physical or mental health." If participants responded positively to either question, they were prompted for additional details and to rate the severity of the experience.
Questionnaires assessing negative effects from using the app and adverse health events
Time frame: Week 6 (2-week follow-up post-intervention)
The Intervention group was asked "Have you experienced any negative effects from using the Alena app? This could be a physical or emotional effect that you believe you have experienced as a result of using the app and/or engaging in the app therapy." Both groups were asked: "Have you experienced any new, serious negative health effects in the past week? This includes having to see your GP for a new reason, going to hospital, or being otherwise very unwell in terms of your physical or mental health." If participants responded positively to either question, they were prompted for additional details and to rate the severity of the experience.
Questionnaire assessing satisfaction, helpfulness and ease of use
Time frame: Week 4 (primary endpoint)
Participants were asked how satisfied they were with the app overall (Likert rating scale from very dissatisfied to very satisfied); how helpful they found the app (Likert ratings from very unhelpful to very helpful); how likely they would be to recommend the app (Likert ratings from very unlikely to very likely); how easy they found using the app (Likert ratings from very difficult to very easy); whether they got to the end of the weekly exercise (yes/no), and what got in the way of completing the exercises, with options provided.
Questionnaire assessing satisfaction, helpfulness and ease of use
Time frame: Week 6 (2-week follow-up post-intervention)
Participants were asked how satisfied they were with the app overall (Likert rating scale from very dissatisfied to very satisfied); how helpful they found the app (Likert ratings from very unhelpful to very helpful); how likely they would be to recommend the app (Likert ratings from very unlikely to very likely); how easy they found using the app (Likert ratings from very difficult to very easy); whether they got to the end of the weekly exercise (yes/no), and what got in the way of completing the exercises, with options provided.
4 secondary outcomes
Social phobia inventory (SPIN)
Time frame: Week 4 (primary endpoint)
Social phobia inventory (SPIN)
Time frame: Week 6 (2-week follow-up post-intervention)
Work and Social Adjustment Scale (WSAS)
Time frame: Week 4 (primary endpoint)
Work and Social Adjustment Scale (WSAS)
Time frame: Week 6 (2-week follow-up post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Background: PubMed 10827888Connor KM, Davidson JR, Churchill LE, Sherwood A, Foa E, Weisler RH. Psychometric properties of the Social Phobia Inventory (SPIN). New self-rating scale. Br J Psychiatry. 2000 Apr;176:379-86. doi: 10.1192/bjp.176.4.379.
- Background: PubMed 11983645Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
- Derived from this study: PubMed 40208666Garvert MM, McFadyen J, Linke S, McCloud T, Meyer SS, Sobanska S, Sharp PB, Long A, Huys QJM, Ahmadi M. Safety and Efficacy of Modular Digital Psychotherapy for Social Anxiety: Randomized Controlled Trial. J Med Internet Res. 2025 Apr 10;27:e64138. doi: 10.2196/64138.
- Individual participant dataSharing planned: No
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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.
Mandana Ahmadi, PhD principal investigator
Aya Technologies Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy programme in people with Social Anxiety and Social Anxiety Disorder, run by Aya Technologies Limited 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 7 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: finished, as of the sponsor's last update on 15 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Questionnaires assessing negative effects from using the app and adverse health events (time frame: Week 4 (primary endpoint)). The study lists 4 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 NCT05858294, which also lists 3 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 15 May 2023.