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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: STAGE training for 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 Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Kent
    • Tunbridge Wells, Kent, United Kingdom, TN1 2YG
      • Canterbury Christ Church University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STAGE course	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.
No Intervention: Wait-list control; The wait-list control group will receive access to the STAGE course after the trial is complete.

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: Canterbury Christ Church University
• Investigators: Principal Investigator: Asuka Boyle, MSc, Canterbury Christ Church University; Study Director: Emma Travers-Hill, PhD, PsychD, Kent and Medway Nhs and Social Care Partnership Trust

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2019
• Primary Completion (Actual): January 10, 2020
• Study Completion (Actual): January 10, 2020

Study Registration Dates

• First Submitted: October 4, 2019
• First Submitted That Met QC Criteria: October 4, 2019
• First Posted (Actual): October 7, 2019

Study Record Updates

• Last Update Posted (Actual): August 20, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: AsukaBoyleMRP2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No