AnxietyNCT04117906
Developing and Piloting an Online, Self-help Intervention (STAGE) for Anxiety
A study testing STAGE training for anxiety in people with Anxiety, run by Canterbury Christ Church University at 1 site in United Kingdom.
Trial summary
This study pilots a novel, brief, online, self-help training course for anxiety management, aimed at adults experiencing moderate to moderately-severe anxiety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- STAGE training for anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Nov 2019to 10 Jan 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- having a score, at baseline, on the Generalised Anxiety Disorder 7 (GAD-7) scale of between 8 and 15, inclusive;
- having regular internet access;
- being based in the UK.
Who cannot join
- significant risk issues in the last year;
- currently receiving another psychological intervention, whether it be self-help or face-to-face;
- having recently (within the last six months) completed a psychological intervention.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Canterbury Christ Church University
Royal Tunbridge Wells, Kent, TN1 2YG
About this study
Official title: Developing and Piloting an Online, Self-help Intervention for Anxiety
This study pilots a novel, brief, online, self-help training course for anxiety management, aimed at adults experiencing moderate to moderately-severe anxiety.
Read the detailed description
This study is a pilot randomised controlled trial (RCT) comparing a brief, online self-help, anxiety management training course ('STAGE') with a wait-list control. A battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 3) and at follow-up (week 5).
- Conditions
- Anxiety
- Being tested
- STAGE training for anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAGE training for anxietyBehavioural
STAGE is a brief, online, self-help course designed to target anxiety through providing training in perspective broadening and self-distancing.
| Study group | Role | What they receive |
|---|---|---|
| STAGE course | Experimental | Not described Receives: Behavioral: STAGE training for anxiety |
| Wait-list control | No intervention | The wait-list control group will receive access to the STAGE course after the trial is complete. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline (week 0) at post-intervention (week 3) on the Generalised Anxiety Disorder 7 (GAD-7) scale.
The Generalised Anxiety Disorder 7 (GAD-7) scale is a self-report measure of general anxiety, producing a total score between 0 and 21, with higher scores indicating greater levels of general anxiety.
Measured: Post-intervention (3 weeks after baseline).
Secondary outcomes (9)
Change from baseline (week 0) at follow-up (week 5) on the Generalised Anxiety Disorder 7 (GAD-7) scale.
As described above
Measured: Follow-up (5 weeks after baseline).
Change from baseline (week 0) at post-intervention (week 3) on the Patient Health Questionnaire 9 (PHQ-9).
The Patient Health Questionnaire 9 (PHQ-9) is a self-report measure of depression, producing a total score between 0 and 27, with higher scores indicating greater levels of depression.
Measured: Post-intervention (3 weeks after baseline).
Change from baseline (week 0) at follow-up (week 5) on the Patient Health Questionnaire 9 (PHQ-9).
As described above
Measured: Follow-up (5 weeks after baseline).
Change from baseline (week 0) at post-intervention (week 3) on the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).
The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) is a self-report measure of mental wellbeing, producing a total score between 14 and 70, with higher scores indicating greater levels of mental wellbeing.
Measured: Post-intervention (3 weeks after baseline).
Change from baseline (week 0) at follow-up (week 5) on the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).
As described above
Measured: Follow-up (5 weeks after baseline).
Change from baseline (week 0) at post-intervention (week 3) on the Experience Questionnaire (EQ).
The Experience Questionnaire (EQ) is a self-report measure of decentering, producing a total score between 20 and 100, with higher scores indicating greater levels of decentering.
Measured: Post-intervention (3 weeks after baseline).
Change from baseline (week 0) at follow-up (week 5) on the Experience Questionnaire (EQ).
As described above
Measured: Follow-up (5 weeks after baseline).
Change from baseline (week 0) at post-intervention (week 3) on the Putting into Perspective subscale of the Cognitive Emotion Regulation Questionnaire (CERQ).
The Putting into Perspective subscale of the Cognitive Emotion Regulation Questionnaire (CERQ) is a self-report measure of perspective taking, producing a total score between 4 and 20.
Measured: Post-intervention (3 weeks after baseline).
Change from baseline (week 0) at follow-up (week 5) on the Putting into Perspective subscale of the Cognitive Emotion Regulation Questionnaire (CERQ).
As described above
Measured: Follow-up (5 weeks after baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start2 Nov 2019
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canterbury Christ Church University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asuka Boyle, MSc, Principal investigator, Canterbury Christ Church UniversityFergal Jones, PhD, PsychD, Study director, Canterbury Christ Church UniversityEmma Travers-Hill, PhD, PsychD, Study director, Kent and Medway NHS and Social Care Partnership Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117906
- Sponsor's protocol ID
- AsukaBoyleMRP2017
- Status last verified
- Oct 2019
- First submitted
- 4 Oct 2019
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Piloting an Online, Self-help Intervention for Anxiety
- ClinicalTrials.gov ID
- NCT04117906
- Acronym / sponsor ID
- AsukaBoyleMRP2017
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Canterbury Christ Church UniversityUniversity, hospital or other
- Study start
- 2 Nov 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 7 Oct 2019 (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.
This study pilots a novel, brief, online, self-help training course for anxiety management, aimed at adults experiencing moderate to moderately-severe anxiety.
Detailed description
This study is a pilot randomised controlled trial (RCT) comparing a brief, online self-help, anxiety management training course ('STAGE') with a wait-list control. A battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 3) and at follow-up (week 5).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STAGE course | Experimental | Behavioral: STAGE training for anxiety |
| Wait-list control | No intervention | –The wait-list control group will receive access to the STAGE course after the trial is complete. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- having a score, at baseline, on the Generalised Anxiety Disorder 7 (GAD-7) scale of between 8 and 15, inclusive;
- having regular internet access;
- being based in the UK.
Key exclusion criteria (3 listed)
- significant risk issues in the last year;
- currently receiving another psychological intervention, whether it be self-help or face-to-face;
- having recently (within the last six months) completed a psychological intervention.
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 |
|---|---|---|
| STAGE training for anxietySTAGE is a brief, online, self-help course designed to target anxiety through providing training in perspective broadening and self-distancing. | Behavioural | STAGE course |
Primary outcome
Change from baseline (week 0) at post-intervention (week 3) on the Generalised Anxiety Disorder 7 (GAD-7) scale.
Time frame: Post-intervention (3 weeks after baseline).
The Generalised Anxiety Disorder 7 (GAD-7) scale is a self-report measure of general anxiety, producing a total score between 0 and 21, with higher scores indicating greater levels of general anxiety.
9 secondary outcomes
Change from baseline (week 0) at follow-up (week 5) on the Generalised Anxiety Disorder 7 (GAD-7) scale.
Time frame: Follow-up (5 weeks after baseline).
Change from baseline (week 0) at post-intervention (week 3) on the Patient Health Questionnaire 9 (PHQ-9).
Time frame: Post-intervention (3 weeks after baseline).
Change from baseline (week 0) at follow-up (week 5) on the Patient Health Questionnaire 9 (PHQ-9).
Time frame: Follow-up (5 weeks after baseline).
Change from baseline (week 0) at post-intervention (week 3) on the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).
Time frame: Post-intervention (3 weeks after baseline).
Change from baseline (week 0) at follow-up (week 5) on the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).
Time frame: Follow-up (5 weeks after baseline).
Change from baseline (week 0) at post-intervention (week 3) on the Experience Questionnaire (EQ).
Time frame: Post-intervention (3 weeks after baseline).
Change from baseline (week 0) at follow-up (week 5) on the Experience Questionnaire (EQ).
Time frame: Follow-up (5 weeks after baseline).
Change from baseline (week 0) at post-intervention (week 3) on the Putting into Perspective subscale of the Cognitive Emotion Regulation Questionnaire (CERQ).
Time frame: Post-intervention (3 weeks after baseline).
Change from baseline (week 0) at follow-up (week 5) on the Putting into Perspective subscale of the Cognitive Emotion Regulation Questionnaire (CERQ).
Time frame: Follow-up (5 weeks after baseline).
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 20 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Recruiting
TOUCHminds: Help-seeking in Adolescents With Anxiety
Anxiety Symptoms, Anxiety Disorders
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Recruiting
A Comparison of Heart Rate Variability Biofeedback, Mindfulness, and Psychoeducation-based Interventions on Clinical Recovery Outcomes in Patients Undergoing Total Knee Arthroplasty
Pain (Knee), Pain and Anxiety
Active, not recruiting
Relaxation Techniques and Pilates for Menopause Symptoms
Women Over 40 Years of Age in the Perimenopausal or Menopausal Stage, Presenting With Associated Symptoms
RecruitingObservational study
Evaluation of Preoperative Anxiety in Digestive Surgery
Digestive System Neoplasms, Anxiety
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.
Asuka Boyle, MSc principal investigator
Canterbury Christ Church University
Fergal Jones, PhD, PsychD study director
Canterbury Christ Church University
Emma Travers-Hill, PhD, PsychD study director
Kent and Medway NHS and Social Care Partnership 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 STAGE training for anxiety in people with Anxiety, run by Canterbury Christ Church University 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 3 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 20 Aug 2020. 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?
Change from baseline (week 0) at post-intervention (week 3) on the Generalised Anxiety Disorder 7 (GAD-7) scale. (time frame: Post-intervention (3 weeks after baseline).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2020; AzTrials last refreshed its copy on 28 Oct 2026.