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

Primary Purpose

Stroke, CVA (Cerebrovascular Accident), Anxiety

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Helping Ease Anxiety and Depression following Stroke
Sponsored by
Glasgow Caledonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring Stroke, CVA, Anxiety, Depression, Mindfulness, MBSR, Online, Self-management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Glasgow Caledonian University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Online HEADS: UP

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.
. 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.
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.
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.
Focus group
Focus Groups (FGs) will be used to collect qualitative data.

Secondary Outcome Measures

Full Information

First Posted
September 8, 2020
Last Updated
May 10, 2021
Sponsor
Glasgow Caledonian University
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1. Study Identification

Unique Protocol Identification Number
NCT04567472
Brief Title
HEADS: UP Online Psychological Self-management Intervention: Feasibility 2
Official Title
HEADS: UP (Helping Ease Anxiety and Depression Following Stroke) Online Psychological Self-management Intervention: Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
April 27, 2021 (Actual)
Study Completion Date
April 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glasgow Caledonian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, CVA (Cerebrovascular Accident), Anxiety, Depression
Keywords
Stroke, CVA, Anxiety, Depression, Mindfulness, MBSR, Online, Self-management

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online HEADS: UP
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Helping Ease Anxiety and Depression following Stroke
Other Intervention Name(s)
HEADS: UP
Intervention 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.
Primary Outcome Measure Information:
Title
Beck Depression Inventory II (BDI-II): change is being assessed
Description
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.
Time Frame
Weeks 0, 9
Title
Beck Anxiety Inventory (BAI): change is being assessed
Description
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.
Time Frame
0, 9 weeks
Title
. Depression Anxiety Stress Scale (DASS): change is being assessed
Description
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.
Time Frame
Weeks 0, 9
Title
EQ-5D 5L: change is being assessed
Description
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.
Time Frame
Weeks 0, 9
Title
Stroke Impact Scale (SIS): change is being assessed
Description
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.
Time Frame
Weeks 0, 9
Title
Focus group
Description
Focus Groups (FGs) will be used to collect qualitative data.
Time Frame
Week 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maggie Lawrence, Dr.
Organizational Affiliation
Glasgow Caledonian University
Official's Role
Study Director
Facility Information:
Facility Name
Glasgow Caledonian University
City
Glasgow
State/Province
Glasgow (City Of)
ZIP/Postal Code
G4 0BA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.cso.scot.nhs.uk/wp-content/uploads/HIPS1663RPB.pdf
Description
HELPING EASE ANXIETY AND DEPRESSION AFTER STROKE (HEADS: UP)

Learn more about this trial

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

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