Developing and Piloting an Online, Self-help Intervention (STAGE) for Anxiety

Study Overview
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Brief Summary
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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
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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).

Official Title
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Developing and Piloting an Online, Self-help Intervention for Anxiety

Conditions
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Anxiety

Intervention / Treatment
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* Behavioral: STAGE training for anxiety


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STAGE course<br> | Behavioral: STAGE training for anxiety<br>* STAGE is a brief, online, self-help course designed to target anxiety through providing training in perspective broadening and self-distancing.<br>|
| No Intervention: Wait-list control<br>The wait-list control group will receive access to the STAGE course after the trial is complete. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Post-intervention (3 weeks after baseline). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (week 0) at follow-up (week 5) on the Generalised Anxiety Disorder 7 (GAD-7) scale. | As described above | 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. | 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 | 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. | 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 | 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. | Post-intervention (3 weeks after baseline). | 
| Change from baseline (week 0) at follow-up (week 5) on the Experience Questionnaire (EQ). | As described above | 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. | 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 | Follow-up (5 weeks after baseline). |