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

Sponsor
Canterbury Christ Church University (Other)
Overall Status
Completed
CT.gov ID
NCT04117906
Collaborator
(none)
77
1
2
2.3
34

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: STAGE training for anxiety
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
77 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Measures will be completed online without direct involvement from the research team.
Primary Purpose:
Treatment
Official Title:
Developing and Piloting an Online, Self-help Intervention for Anxiety
Actual Study Start Date :
Nov 2, 2019
Actual Primary Completion Date :
Jan 10, 2020
Actual Study Completion Date :
Jan 10, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. 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.

  7. Change from baseline (week 0) at follow-up (week 5) on the Experience Questionnaire (EQ). [Follow-up (5 weeks after baseline).]

    As described above

  8. 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.

  9. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Canterbury Christ Church University Tunbridge Wells Kent United Kingdom TN1 2YG

Sponsors and Collaborators

  • Canterbury Christ Church University

Investigators

  • Principal Investigator: Asuka Boyle, MSc, Canterbury Christ Church University
  • Study Director: Fergal Jones, PhD, PsychD, Canterbury Christ Church University
  • Study Director: Emma Travers-Hill, PhD, PsychD, Kent and Medway NHS and Social Care Partnership Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Canterbury Christ Church University
ClinicalTrials.gov Identifier:
NCT04117906
Other Study ID Numbers:
  • AsukaBoyleMRP2017
First Posted:
Oct 7, 2019
Last Update Posted:
Aug 20, 2020
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 20, 2020