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Self-guided Psychosocial Intervention for Facial Palsy

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ClinicalTrials.gov Identifier: NCT03943953
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew Hotton, Oxford University Hospitals NHS Trust

Brief Summary:

Facial palsy affects between 23 to 35 people per 100,000. As well as affecting an individual's appearance, it also can lead to difficulties with: eating, drinking, speaking, eyelid closure, pain and taste.

Facial palsy has been shown to have a significant impact on an individual's psychological wellbeing, including issues with anxiety, depression and low self-esteem. These elevated levels of distress have been thought to be partly due to the impact that facial palsy has on the face's ability to express emotions, which is a crucial aspect of face-to-face communication.

Although not researched yet in a facial palsy population, one type of psychological intervention that has been found to be effective at improving the psychosocial wellbeing of people with visible differences has been psychological self-help. With this in mind, the investigators have developed seven self-guided information and therapy guides (ITGs), for people with facial palsy and/or their friends or relatives. The investigators have written these guides by drawing on interventions with a strong evidence-base in other populations, such as cognitive behavioural therapy, social skills training and acceptance and commitment therapy:

  1. Facial palsy: Coping with the early stages.
  2. Facial palsy: Coping with comments, questions and staring.
  3. Facial palsy: Communicating with confidence.
  4. Facial palsy: Managing anxiety.
  5. Facial palsy: Managing your mood.
  6. Facial palsy: Building your self-esteem.
  7. Facial palsy: Advice for friends, family and partners.

The investigators aim to evaluate the effectiveness, usability and acceptability of these guides to people with facial palsy and/or their friends, family and partners, by piloting their use over a 4-6 week period. Assessment of psychosocial wellbeing will be carried out before and after the 4-6 week period, while participants will be invited to provide usability and acceptability feedback on the guides after the 4-6 week period.


Condition or disease Intervention/treatment Phase
Facial Palsy Behavioral: Information and Therapy Guides Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: One single group will be trialling a new self-guided psychological intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Evaluating the Effectiveness of Information and Therapy Guides for Improving the Psychosocial Wellbeing of People With Facial Palsy.
Actual Study Start Date : August 15, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Facial Palsy - Trial of ITG
In this arm of the trial individuals with facial palsy will trial the use of information and therapy guides over a 4-6 week period. They will complete measures at the start and end of this period.
Behavioral: Information and Therapy Guides

We have developed seven self-guided information and therapy guides (ITGs), for people with facial palsy and/or their friends or relatives. We have written these guides by drawing on interventions with a strong evidence-base in other populations, such as cognitive behavioural therapy, social skills training and acceptance and commitment therapy:

  1. Facial palsy: Coping with the early stages.
  2. Facial palsy: Coping with comments, questions and staring.
  3. Facial palsy: Communicating with confidence.
  4. Facial palsy: Managing anxiety.
  5. Facial palsy: Managing your mood.
  6. Facial palsy: Building your self-esteem.
  7. Facial palsy: Advice for friends, family and partners.

Experimental: Friends or relatives - Trial of ITG
In this arm of the trial friends or relatives of individuals with facial palsy will trial the use of information and therapy guides over a 4-6 week period. They will complete measures at the start and end of this period.
Behavioral: Information and Therapy Guides

We have developed seven self-guided information and therapy guides (ITGs), for people with facial palsy and/or their friends or relatives. We have written these guides by drawing on interventions with a strong evidence-base in other populations, such as cognitive behavioural therapy, social skills training and acceptance and commitment therapy:

  1. Facial palsy: Coping with the early stages.
  2. Facial palsy: Coping with comments, questions and staring.
  3. Facial palsy: Communicating with confidence.
  4. Facial palsy: Managing anxiety.
  5. Facial palsy: Managing your mood.
  6. Facial palsy: Building your self-esteem.
  7. Facial palsy: Advice for friends, family and partners.




Primary Outcome Measures :
  1. Hospital Anxiety and Depression Scale - person with facial palsy [ Time Frame: At baseline and upon completion of the 4-6 week trial period ]
    A 14-item scale with two seven-item subscales looking at anxiety and depression. A score equal-to-or-lower-than 7 on a subscale falls below the clinical cut-off, a score of 8-10 indicates probably clinically significant anxiety or depression, while a score of 11 or more indicates clinically significant anxiety or depression. It is well validated in the physical health population, excluding somatic symptoms of anxiety and depression that may overlap with symptoms of a physical health condition. It has been shown to have good test-retest reliability (= .70 to .84; 16).

  2. FACE-Q Satisfaction with appearance - person with facial palsy [ Time Frame: At baseline and upon completion of the 4-6 week trial period ]
    A nine-item scale assessing an individual's concerns regarding their facial appearance. The higher the score, the greater the patient's dissatisfaction with their appearance, with a highest possible score being 32. This measure has been demonstrated to have good reliability within a plastic surgery population.

  3. FACE-Q Psychological function - person with facial palsy [ Time Frame: At baseline and upon completion of the 4-6 week trial period ]
    This 11-item scale measures psychological wellbeing using a series of positively worded statements, with participants invited to rate how much they agree/disagree with each statement. A high score (maximum = 40) indicates greater psychological wellbeing. This measure has been validated within a clinical setting and has been shown to have a Cronbach alpha of .96, indicating very good internal consistency

  4. FACE-Q Social functioning - person with facial palsy [ Time Frame: At baseline and upon completion of the 4-6 week trial period ]
    Like the FACE-Q psychological function scale, participants are provided with a series of positively worded statements. In this scale there are 9 statements and they pertain to measuring social functioning. Just as with the psychological function scale, the social functioning scale has a Cronbach alpha of .96 and has been shown to have good convergent and discriminant construct validity.

  5. Facial Disability Index - person with facial palsy [ Time Frame: At baseline and upon completion of the 4-6 week trial period ]
    A 10-item self-report measure of physical and social function in people with facial palsy. Both the physical (=.88) and social (=.83) subscales have been shown to have good internal consistency and construct validity. Each scale is scored out of 100 (100 = high function).


Secondary Outcome Measures :
  1. Hospital Anxiety and Depression Scale - friend, relative or carer [ Time Frame: At baseline and upon completion of the 4-6 week trial period ]
    A 14-item scale with two seven-item subscales looking at anxiety and depression. A score equal-to-or-lower-than 7 on a subscale falls below the clinical cut-off, a score of 8-10 indicates probably clinically significant anxiety or depression, while a score of 11 or more indicates clinically significant anxiety or depression. It is well validated in the physical health population, excluding somatic symptoms of anxiety and depression that may overlap with symptoms of a physical health condition. It has been shown to have good test-retest reliability (= .70 to .84; 16).

  2. Adult carer quality of life questionnaire [ Time Frame: At baseline and upon completion of the 4-6 week trial period ]
    This is a 40-item self-report scale that measures the overall quality of life for adult carers. Subscale scores include: support for caring; caring choice; caring stress; money matters; personal growth; sense of value; ability to care and carer satisfaction. Scores fall on a 0-120 scale, with higher scores indicating better quality of life.


Other Outcome Measures:
  1. Participant satisfaction [ Time Frame: At baseline, half-way through the intervention and upon completion of the 4-6 week trial period ]
    Satisfaction questionnaire designed to evaluate the acceptability and usability of the Information and Therapy Guides



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

Participant with Facial Palsy:

  • Participant is willing and able to give informed consent for participation in the study.
  • Aged 18 years or above.
  • Current diagnosis of facial palsy, of any severity or aetiology.
  • Participants experience one or more psychosocial difficulties related to facial palsy 'all the time' or 'a lot of the time', as assessed by a screening questionnaire

Participant who is a friend, family member or partner of someone with facial palsy:

  • Participant is willing and able to give informed consent for participation in the study.
  • Aged 18 years or above.
  • Is a friend, family member or partner of an adult with facial palsy, of any severity or aetiology.
  • Participants experience psychosocial difficulties related to supporting someone with facial palsy, as assessed by participant responding 'all the time' or 'a lot of the time' to one or more questions on a screening questionnaire

Exclusion Criteria:

Participant with Facial Palsy:

  • The participant is not in within the target age range (e.g. under the age of 18 years).
  • They are not an individual with a current diagnosis of facial palsy.
  • They do not speak enough English to understand the questionnaires or ITGs.
  • They do not meet eligibility on the screening questionnaire (i.e. they 'never' or 'only occasionally' experience psychosocial difficulties associated with facial palsy (see section 7.2 Screening and Eligibility Assessment).

Participant who is a friend, family member or partner of someone with facial palsy:

  • The participant is not in within the target age range (e.g. under the age of 18 years).
  • They are not a friend, family member or partner of an adult with a current diagnosis of facial palsy.
  • They do not speak enough English to understand the questionnaires or ITG.
  • They do not meet eligibility on the screening questionnaire (i.e. they 'never' or 'only occasionally' experience psychosocial difficulties associated with supporting someone with facial palsy

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): NCT03943953


Contacts
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Contact: Matthew Hotton 01865 234714 matthew.hotton@ouh.nhs.uk

Locations
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United Kingdom
John Radcliffe Hospital Recruiting
Oxford, Oxon, United Kingdom, OX3 9DU
Contact: Matthew T Hotton, DClinPsy    01865 234714    Matthew.Hotton@ouh.nhs.uk   
Contact: Louise Dalton, DClinPsy    01865 234714    Louise.Dalton@ouh.nhs.uk   
Principal Investigator: Matthew T Hotton, DClinPsy         
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Investigators
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Principal Investigator: Matthew Hotton Oxford University Hospitals NHS Trust

Publications:
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Responsible Party: Matthew Hotton, Primary Investigator, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03943953     History of Changes
Other Study ID Numbers: 14110
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to make data available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Nervous System Diseases
Disease Attributes
Mouth Diseases
Stomatognathic Diseases
Virus Diseases
Facial Nerve Diseases
Cranial Nerve Diseases
Bell Palsy
Facial Paralysis
Facies
Paralysis
Neurologic Manifestations
Signs and Symptoms
Pathologic Processes
Herpesviridae Infections
DNA Virus Infections