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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04567472
• Other study ID #: HLS/NCH/19/061
• Status: Completed
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: April 27, 2021

Study information

• Verified date: May 2021
• Source: Glasgow Caledonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To test feasibility of online version of HEADS: UP

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 27, 2021
• Est. primary completion date: April 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• CVA (Cerebrovascular Accident)
• Depression
• Depressive Disorder
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Glasgow Caledonian University	Glasgow	Glasgow (City Of)

Sponsors (1)

Lead Sponsor	Collaborator
Glasgow Caledonian University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory II (BDI-II): change is being assessed	The Beck Depression Inventory 11 (BDI-II) is a 21 items self-report scale to assess the intensity of depression. Each item is a list of four statements arranged in increasing severity about a symptom of depression. Score range between 0-63 with higher score indicating greater severity. Normally completed in 5-10 minutes.	Weeks 0, 9
Primary	Beck Anxiety Inventory (BAI): change is being assessed	The Beck Anxiety Inventory (BAI) is a self-report 21-item scale for measuring anxiety. The questions ask about symptoms of anxiety the subject has had during the past week. Each question is scored between 0 (mild) and 3 (severe) and a total score will vary between 0-63. Higher scores indicate more severe anxiety symptoms.	0, 9 weeks
Primary	. Depression Anxiety Stress Scale (DASS): change is being assessed	The DASS is a set of three self-report scales designed to measure depression, anxiety and stress. Each of the three DASS scales contains 14 items, divided into subscales of 2-5 items with similar content. The Depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia, and inertia. The Anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The Stress scale is sensitive to levels of chronic non-specific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient. Subjects are asked to use 4-point severity/frequency scales to rate the extent to which they have experienced each state over the past week. Scores for Depression, Anxiety and Stress are calculated by summing the scores for the relevant items.	Weeks 0, 9
Primary	EQ-5D 5L: change is being assessed	The 5-level EQ-5D version (EQ-5D-5L) comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	Weeks 0, 9
Primary	Stroke Impact Scale (SIS): change is being assessed	The Stroke Impact Scale (SIS) is a self-report, health status measure for people affected by stroke. It was designed to assess strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, and participation. The SIS can be used both in clinical and research settings. It contains 59 items and assesses 8 domains. Each item is rated using a 5-point Likert scale. A final single-item question assesses the individual's perception of recovery from stroke, measured using a visual analogue scale, where 0 = no recovery & 100 = full recovery. The scale is normally completed in 15-20 minutes.	Weeks 0, 9
Primary	Focus group	Focus Groups (FGs) will be used to collect qualitative data.	Week 9

External Links

•   HELPING EASE ANXIETY AND DEPRESSION AFTER STROKE (HEADS: UP)