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

NCT04117906 | Completed

• 1 other identifier: AsukaBoyleMRP2017
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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 post-intervention (week 3) on the Patient Health Questionnaire 9 (PHQ-9).

  Post-intervention (3 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 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 Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).

  Follow-up (5 weeks after baseline).

Study Arms (2)

STAGE course

EXPERIMENTAL

Behavioral: STAGE training for anxiety

Wait-list control

NO INTERVENTION

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

Interventions

STAGE training for anxiety BEHAVIORAL

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

STAGE course

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canterbury Christ Church University: lead

Study Sites (1)

Canterbury Christ Church University

Royal Tunbridge Wells, Kent, TN1 2YG, United Kingdom

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Asuka Boyle, MSc

  Canterbury Christ Church University

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Measures will be completed online without direct involvement from the research team.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 7, 2019
• Study Start: November 2, 2019
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2020
• Last Updated: August 20, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)