NCT04567472

HEADS: UP Online Psychological Self-management Intervention: Feasibility 2

HEADS: UP (Helping Ease Anxiety and Depression Following Stroke) Online Psychological Self-management Intervention: Feasibility Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Glasgow Caledonian University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To test feasibility of online version of HEADS: UP

Detailed description

Study aim(s): to conduct feasibility testing of online HEADS: UP, a tailored adaptation of an existing psychological intervention (MBSR) to help people affected by stroke self-manage symptoms of anxiety and depression. Objectives: 1) Assess feasibility and acceptability of delivering the HEADS: UP intervention online and identify any additional adaptations to the HEADS: UP manual and supporting materials. 2) Assess feasibility and acceptability of online research processes, including recruitment, screening, and obtaining informed consent, and data collection processes. Research question: What elements of intervention design, delivery, and study processes require to be optimised ahead of a 3-arm RCT?

Conditions

• Stroke
• CVA (Cerebrovascular Accident)
• Anxiety
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Helping Ease Anxiety and Depression following Stroke	HEADS: UP online is a group-based mindfulness course with an accompanying text-based manual. HEADS: UP comprises 9 x 2.5 hour mindfulness sessions, which incorporate a 30-minute break. A 6-hour silent retreat is offered in week 7. A follow-up session will be offered 6 - 8 weeks after the end of the course. Course materials include accessible information packs delivered weekly, electronically, and CD/audio resources to complement the sessions. The accompanying text-based manual will be delivered 'up front' (hard copy and electronic). A summary email and reminder of personal practice will be sent to participants after each session, including links to audio resources complementing class-based sessions. Signposting to other resources and media, including sites with downloadable voice files e.g. Mindfulness Scotland will be included.

Timeline

• Start date: 2020-10-19
• Primary completion: 2021-04-27
• Completion: 2021-04-27
• First posted: 2020-09-28
• Last updated: 2021-05-11

Locations

1 site across 1 country: United Kingdom