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

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Behavioral: STAGE training for anxiety

• Registration Number: NCT04117906
• Lead Sponsor: Canterbury Christ Church University

Brief Summary

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 Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-04
• Study First Submitted QC: 2019-10-04
• Study First Posted: 2019-10-07
• Study Start: 2019-11-02
• Primary Completion: 2020-01-10
• Study Completion: 2020-01-10
• Last Update Submitted: 2020-08-19
• Last Update Posted: 2020-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STAGE course	STAGE training for anxiety	-

Primary Outcome Measures

Name	Time	Method
Change from baseline (week 0) at post-intervention (week 3) on the Generalised Anxiety Disorder 7 (GAD-7) scale.	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline (week 0) at follow-up (week 5) on the Generalised Anxiety Disorder 7 (GAD-7) scale.	Follow-up (5 weeks after baseline).	As described above
Change from baseline (week 0) at follow-up (week 5) on the Patient Health Questionnaire 9 (PHQ-9).	Follow-up (5 weeks after baseline).	As described above
Change from baseline (week 0) at follow-up (week 5) on the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).	Follow-up (5 weeks after baseline).	As described above
Change from baseline (week 0) at post-intervention (week 3) on the Experience Questionnaire (EQ).	Post-intervention (3 weeks after baseline).	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.
Change from baseline (week 0) at post-intervention (week 3) on the Patient Health Questionnaire 9 (PHQ-9).	Post-intervention (3 weeks after baseline).	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.
Change from baseline (week 0) at post-intervention (week 3) on the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).	Post-intervention (3 weeks after baseline).	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.
Change from baseline (week 0) at follow-up (week 5) on the Experience Questionnaire (EQ).	Follow-up (5 weeks after baseline).	As described above
Change from baseline (week 0) at post-intervention (week 3) on the Putting into Perspective subscale of the Cognitive Emotion Regulation Questionnaire (CERQ).	Post-intervention (3 weeks after baseline).	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.
Change from baseline (week 0) at follow-up (week 5) on the Putting into Perspective subscale of the Cognitive Emotion Regulation Questionnaire (CERQ).	Follow-up (5 weeks after baseline).	As described above

Trial Locations

Locations (1)

Canterbury Christ Church University; 🇬🇧 Tunbridge Wells, Kent, United Kingdom