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Helping Ease Anxiety and Depression Following Stroke (HEADS:UP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03956693
Recruitment Status : Completed
First Posted : May 21, 2019
Last Update Posted : September 9, 2020
Sponsor:
Collaborators:
University of Stirling
Edinburgh Napier University
The Stroke Association, United Kingdom
Yunus Centre for Social Business and Health
University of Strathclyde
University of Manchester
Information provided by (Responsible Party):
Glasgow Caledonian University

Brief Summary:
The aim of this mixed methods research is to conduct feasibility pilot testing of an existing mindfulness intervention called HEADS: UP. The intervention is designed to help people affected by stroke self-manage symptoms of anxiety and depression.

Condition or disease Intervention/treatment Phase
Stroke CVA (Cerebrovascular Accident) Anxiety Depression Behavioral: HEADS: UP Not Applicable

Detailed Description:

Mindfulness-based interventions are thought to help people affected by stroke (Lawrence et al., 2013). Helping Ease Anxiety and Depression (HEADS: UP) is an adapted mindfulness-based intervention for people affected by stroke (Lawrence, 2019). This study aligns with the feasibility/piloting stage of the Medical Research Council framework (Craig et al., 2008) and will optimise intervention delivery and study processes, ensuring all elements are working together, ready for testing at a later stage.

The aim of this mixed methods research is to conduct feasibility pilot testing of HEADS: UP to help people affected by stroke self-manage symptoms of anxiety and depression prior to Phase III testing in future work.

This stage is a non-randomised pilot study based in Glasgow, United Kingdom. The purpose of the pilot is to assess feasibility and acceptability of delivering HEADS: UP, and recruitment and questionnaire data collection processes; identify any additional HEADS: UP adaptions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: HEADS: UP (Helping Ease Anxiety and Depression Following Stroke) Psychological Self-management Intervention: Non-randomised Pilot Study
Actual Study Start Date : June 1, 2019
Actual Primary Completion Date : October 22, 2019
Actual Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: HEADS: UP
HEADS: UP is group-based mindfulness intervention based on the original mindfulness based stress reduction course, but adapted for people affected by stroke.
Behavioral: HEADS: UP

HEADS: UP comprises 9 x 2.5 hour mindfulness teaching sessions and a silent retreat in week 7. Course materials include accessible information packs and resources to complement class-based sessions.

The first week of the 9-week course is an introductory class. The purpose of the introductory class is to give participants the opportunity to meet the trainers and to decide if they want to learn more about mindfulness. The introductory session also allows participants to meet other people on the course and to share their (stroke) stories.





Primary Outcome Measures :
  1. Stroke Specific Quality of Life Scale (SS-QOL): change is being assessed [ Time Frame: Weeks 0, 9, 21 ]
    The Stroke Specific Quality of Life Scale (SS-QOL) is an outcome measure intended to assess of health-related quality of life for people affected by stroke. It is a self-report scale containing 49 items in 12 domains. Items are rated on a 5-point Likert scale and the questionnaire is usually completed in 10-15 minutes.

  2. Stroke Impact Scale (SIS): change is being assessed [ Time Frame: Weeks 0, 9, 21 ]
    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.


Secondary Outcome Measures :
  1. Hospital Anxiety and Depression Scale (HADS): change is being assessed [ Time Frame: Weeks 0, 9, 21 ]

    The Hospital Anxiety and Depression Scale (HADS) is a self-administered measure of depression and anxiety. The HADS is not a diagnostic tool, but can screen for anxiety and depression. The HADS has 14 items in total and asks about mood in the past week. Seven items assess depression and seven items assess anxiety. The HADS can be administered repeatedly without impacting on validity. Each item is rated on a 4-point scale and provide a score 0-21. A higher score indicates higher distress.

    Usually completed in 2-5 minutes


  2. Depression Anxiety Stress Scale (DASS): change is being assessed [ Time Frame: Weeks 0, 9, 21 ]
    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.

  3. Beck Depression Inventory II (BDI-II): change is being assessed [ Time Frame: Weeks 0, 9, 21 ]

    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.


  4. Beck Anxiety Inventory (BAI): change is being assessed [ Time Frame: Weeks 0, 9 21 ]
    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.

  5. EQ-5D 5L: change is being assessed [ Time Frame: Weeks 0, 9, 21 ]
    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.


Other Outcome Measures:
  1. Carer Strain Index (CSI): change is being assessed [ Time Frame: Weeks 0, 9, 21 ]
    The Carer Strain Index (CSI) is a 13-item self-report questionnaire. The tool covers employment, financial, physical, social and time. Positive responses to 7 or more items on the index indicate a greater level of strain. This instrument can be used to assess individuals of any age who have assumed the role of carer for an older adult.

  2. Focus Groups (FG): change is being assessed [ Time Frame: Weeks 9, 21 ]
    Focus Groups (FGs) will be used to collect qualitative data. Focus groups will explore the feasibility, acceptability, meaningfulness, and effectiveness of the intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have had ≥1 stroke 3-60 months previously (reflects incidence of anxiety/depression)
  • Interested in learning skills to help them cope with self-reported anxiety and/or depression
  • Able to speak and understand conversational English
  • Able to identify a family member/peer who would: like to take part, can speak and understand conversational English; not participating in another trial.

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
  • ≥28 on Behavioural Assessment of Dysexecutive Syndrome (BADS) scale; assesses the cognitive skills required to engage with group-based interventions (goo.gl/uumeFw)
  • Hospital Anxiety and Depression Scale (HADS); screens for anxiety and depression; used extensively in Primary Care research (goo.gl/TtdDDW). A score of 8-10 suggests mood disorder; ≥11 indicates 'probable presence'. A total cut-off score of 11 achieves optimal balance between sensitivity and specificity, and will be used for family/peer participants who have not had a stroke. A lower cut-off score is recommended for stroke survivors i.e. 4 on each sub-scale.

NOTE: A current prescription for anxiolytics or antidepressants is not an exclusion criterion. If screening identifies a potential participant who requires GP referral, that individual may subsequently be prescribed medication; this is a feature of the pilot work. In a future trial, where participants are randomised to two arms and there is equal probability of people being on medication in each arm, it will not be an issue.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956693


Locations
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United Kingdom
Glasgow Caledonian University
Glasgow, Glasgow (City Of), United Kingdom, G4 0BA
Sponsors and Collaborators
Glasgow Caledonian University
University of Stirling
Edinburgh Napier University
The Stroke Association, United Kingdom
Yunus Centre for Social Business and Health
University of Strathclyde
University of Manchester
Investigators
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Study Director: Maggie Lawrence, PhD Glasgow Caledonian University
Additional Information:
Publications:
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Responsible Party: Glasgow Caledonian University
ClinicalTrials.gov Identifier: NCT03956693    
Other Study ID Numbers: SA PPA 18\100011 (stage 1)
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Glasgow Caledonian University:
Stroke
CVA (cardiovascular accident)
Anxiety
Depression
Mindfulness
Mindfulness Based Stress Reduction
Self-management
Additional relevant MeSH terms:
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Stroke
Depression
Depressive Disorder
Anxiety Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders