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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04117906
• Other study ID #: AsukaBoyleMRP2017
• Status: Completed
• Phase: N/A
• Start date: November 2, 2019
• Est. completion date: January 10, 2020

Study information

• Verified date: October 2019
• Source: Canterbury Christ Church University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: January 10, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• STAGE training for anxiety
STAGE is a brief, online, self-help course designed to target anxiety through providing training in perspective broadening and self-distancing.

Locations

Country	Name	City	State
United Kingdom	Canterbury Christ Church University	Tunbridge Wells	Kent

Sponsors (1)

Lead Sponsor	Collaborator
Canterbury Christ Church University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	Change from baseline (week 0) at follow-up (week 5) on the Experience Questionnaire (EQ).	As described above	Follow-up (5 weeks after baseline).
Secondary	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).
Secondary	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).