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

Glasgow Caledonian University

Status: Completed

Conditions: Stroke; Depression; CVA (Cerebrovascular Accident); Anxiety

Treatments: Behavioral: Helping Ease Anxiety and Depression following Stroke

Study type: Interventional

Funder types: Other

Identifiers

NCT04567472

HLS/NCH/19/061

Details and patient eligibility

About

To test feasibility of online version of HEADS: UP

Full 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?

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged ≥18 years
• Have had ≥1 stroke at least 3 months previously
• Interested in learning skills to help cope with self-reported anxiety and/or depression
• Able to speak and understand conversational English
• Score ≥ 4 on either sub-scale Hospital Anxiety and Depression Scale (HADS)
• Desirable: Able to identify a family member/peer who would: like to take part, can speak and understand conversational English; not participating in another trial.

Potential participants who do not identify someone else to take part with them will not be excluded.

Exclusion criteria

• Prior MBSR attendance in the last three years (as this may confound results)
• Current participant in another trial
• Cannot follow a 2-stage command

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Online HEADS: UP

Experimental group

Description:

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.

Treatment:

Behavioral: Helping Ease Anxiety and Depression following Stroke