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

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
STAGE training for anxiety
Sponsored by
Canterbury Christ Church University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Canterbury Christ Church University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

STAGE course

Wait-list control

Arm Description

The wait-list control group will receive access to the STAGE course after the trial is complete.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from baseline (week 0) at follow-up (week 5) on the Generalised Anxiety Disorder 7 (GAD-7) scale.
As described above
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.
Change from baseline (week 0) at follow-up (week 5) on the Patient Health Questionnaire 9 (PHQ-9).
As described above
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.
Change from baseline (week 0) at follow-up (week 5) on the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).
As described above
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.
Change from baseline (week 0) at follow-up (week 5) on the Experience Questionnaire (EQ).
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).
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).
As described above

Full Information

First Posted
October 4, 2019
Last Updated
August 19, 2020
Sponsor
Canterbury Christ Church University
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1. Study Identification

Unique Protocol Identification Number
NCT04117906
Brief Title
Developing and Piloting an Online, Self-help Intervention (STAGE) for Anxiety
Official Title
Developing and Piloting an Online, Self-help Intervention for Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2, 2019 (Actual)
Primary Completion Date
January 10, 2020 (Actual)
Study Completion Date
January 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canterbury Christ Church University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Measures will be completed online without direct involvement from the research team.
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STAGE course
Arm Type
Experimental
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
The wait-list control group will receive access to the STAGE course after the trial is complete.
Intervention Type
Behavioral
Intervention Name(s)
STAGE training for anxiety
Intervention Description
STAGE is a brief, online, self-help course designed to target anxiety through providing training in perspective broadening and self-distancing.
Primary Outcome Measure Information:
Title
Change from baseline (week 0) at post-intervention (week 3) on the Generalised Anxiety Disorder 7 (GAD-7) scale.
Description
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.
Time Frame
Post-intervention (3 weeks after baseline).
Secondary Outcome Measure Information:
Title
Change from baseline (week 0) at follow-up (week 5) on the Generalised Anxiety Disorder 7 (GAD-7) scale.
Description
As described above
Time Frame
Follow-up (5 weeks after baseline).
Title
Change from baseline (week 0) at post-intervention (week 3) on the Patient Health Questionnaire 9 (PHQ-9).
Description
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.
Time Frame
Post-intervention (3 weeks after baseline).
Title
Change from baseline (week 0) at follow-up (week 5) on the Patient Health Questionnaire 9 (PHQ-9).
Description
As described above
Time Frame
Follow-up (5 weeks after baseline).
Title
Change from baseline (week 0) at post-intervention (week 3) on the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).
Description
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.
Time Frame
Post-intervention (3 weeks after baseline).
Title
Change from baseline (week 0) at follow-up (week 5) on the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).
Description
As described above
Time Frame
Follow-up (5 weeks after baseline).
Title
Change from baseline (week 0) at post-intervention (week 3) on the Experience Questionnaire (EQ).
Description
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.
Time Frame
Post-intervention (3 weeks after baseline).
Title
Change from baseline (week 0) at follow-up (week 5) on the Experience Questionnaire (EQ).
Description
As described above
Time Frame
Follow-up (5 weeks after baseline).
Title
Change from baseline (week 0) at post-intervention (week 3) on the Putting into Perspective subscale of the Cognitive Emotion Regulation Questionnaire (CERQ).
Description
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.
Time Frame
Post-intervention (3 weeks after baseline).
Title
Change from baseline (week 0) at follow-up (week 5) on the Putting into Perspective subscale of the Cognitive Emotion Regulation Questionnaire (CERQ).
Description
As described above
Time Frame
Follow-up (5 weeks after baseline).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asuka Boyle, MSc
Organizational Affiliation
Canterbury Christ Church University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fergal Jones, PhD, PsychD
Organizational Affiliation
Canterbury Christ Church University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Emma Travers-Hill, PhD, PsychD
Organizational Affiliation
Kent and Medway NHS and Social Care Partnership Trust
Official's Role
Study Director
Facility Information:
Facility Name
Canterbury Christ Church University
City
Tunbridge Wells
State/Province
Kent
ZIP/Postal Code
TN1 2YG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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

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