Clinical trial NCT04117906: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Canterbury Christ Church University
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change from baseline (week 0) at post-intervention (week 3) on the Generalised Anxiety Disorder 7 (GAD-7) scale.
timeFrame: Post-intervention (3 weeks after baseline).
Secondary outcomes:
measure: Change from baseline (week 0) at follow-up (week 5) on the Generalised Anxiety Disorder 7 (GAD-7) scale.
timeFrame: Follow-up (5 weeks after baseline).
measure: Change from baseline (week 0) at post-intervention (week 3) on the Patient Health Questionnaire 9 (PHQ-9).
timeFrame: Post-intervention (3 weeks after baseline).
measure: Change from baseline (week 0) at follow-up (week 5) on the Patient Health Questionnaire 9 (PHQ-9).
timeFrame: Follow-up (5 weeks after baseline).
measure: Change from baseline (week 0) at post-intervention (week 3) on the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).
timeFrame: Post-intervention (3 weeks after baseline).
measure: Change from baseline (week 0) at follow-up (week 5) on the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).
timeFrame: Follow-up (5 weeks after baseline).
measure: Change from baseline (week 0) at post-intervention (week 3) on the Experience Questionnaire (EQ).
timeFrame: Post-intervention (3 weeks after baseline).
measure: Change from baseline (week 0) at follow-up (week 5) on the Experience Questionnaire (EQ).
timeFrame: Follow-up (5 weeks after baseline).
measure: Change from baseline (week 0) at post-intervention (week 3) on the Putting into Perspective subscale of the Cognitive Emotion Regulation Questionnaire (CERQ).
timeFrame: Post-intervention (3 weeks after baseline).
measure: Change from baseline (week 0) at follow-up (week 5) on the Putting into Perspective subscale of the Cognitive Emotion Regulation Questionnaire (CERQ).
timeFrame: Follow-up (5 weeks after baseline).
Other outcomes:
Locations:
city: Tunbridge Wells
country: United Kingdom
facility: Canterbury Christ Church University
state: Kent
Study officials:
affiliation: Canterbury Christ Church University
name: Asuka Boyle, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Canterbury Christ Church University
name: Fergal Jones, PhD, PsychD
role: STUDY_DIRECTOR
affiliation: Kent and Medway NHS and Social Care Partnership Trust
name: Emma Travers-Hill, PhD, PsychD
role: STUDY_DIRECTOR
References: