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Completed

NCT Number: NCT04117906

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

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Canterbury Christ Church University

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

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Change from baseline (week 0) at follow-up (week 5) on the Generalised Anxiety Disorder 7 (GAD-7) scale.

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: Follow-up (5 weeks after baseline).

    As described above

Sponsors and collaborators

Lead sponsor

Canterbury Christ Church University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 7, 2019
Registry last updated
Aug 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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