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

Canterbury Christ Church University1 site in 1 country77 target enrollmentNovember 2, 2019

ConditionsAnxiety

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anxiety
Sponsor: Canterbury Christ Church University
Enrollment: 77
Locations: 1
Primary Endpoint: Change from baseline (week 0) at post-intervention (week 3) on the Generalised Anxiety Disorder 7 (GAD-7) scale.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

November 2, 2019

End Date

January 10, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Canterbury Christ Church University

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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).)
Change from baseline (week 0) at follow-up (week 5) on the Patient Health Questionnaire 9 (PHQ-9).(Follow-up (5 weeks after baseline).)
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).)
Change from baseline (week 0) at post-intervention (week 3) on the Experience Questionnaire (EQ).(Post-intervention (3 weeks after baseline).)
Change from baseline (week 0) at post-intervention (week 3) on the Patient Health Questionnaire 9 (PHQ-9).(Post-intervention (3 weeks after baseline).)
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).)
Change from baseline (week 0) at follow-up (week 5) on the Experience Questionnaire (EQ).(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).(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).(Follow-up (5 weeks after baseline).)