Self-guided Psychosocial Intervention for Facial Palsy

• ClinicalTrials.gov Identifier: NCT03943953
• Recruitment Status: Completed
• First Posted: May 9, 2019
• Last Update Posted: July 13, 2021
• Sponsor: Oxford University Hospitals NHS Trust
• Information provided by (Responsible Party): Matthew Hotton, Oxford University Hospitals NHS Trust

Study Description

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

Detailed Description:

Given that this study represents an initial pilot of the use of self-guided information and therapy guides for people with facial palsy (and/or their friends and relatives), all eligible participants will receive the intervention (i.e. there will be no control group). As a result, this study will have a repeated-measures design.

Eligible participants will be recruited by one of two means:

1. Face-to-face of recruitment of OUH NHS patients during clinics at the Oxford Facial Palsy Service
2. Recruitment of people with facial palsy, not under the care of the Oxford Facial Palsy Service, through relevant web and social media pages (e.g. the Facial Palsy UK Facebook page)

Potential participants who have expressed an interest in the study will be provided with an information sheet, and be invited to provide written consent. Participants recruited through the Oxford Facial Palsy Service will proved written consent via Survey Hero, either in clinic or remotely online at a later if they wish for longer time to consider their involvement in the study. Participants recruited through Facial Palsy UK/social media will provide written consent via Survey Hero.

Once participants have provided consent, they will be provided with an online screening questionnaire (in order to check for eligibility). Participants recruited in Oxford Facial Palsy Service clinics will complete the screening questionnaire on the researcher's laptop. Alternatively, if participants recruited in clinic wish to have more time to consider whether or not to participate, they will be able to complete online screening (and subsequent baseline assessments) remotely online. Participants recruited on social media will be emailed a link to the screening questionnaire.

Eligible participants will then be invited to complete baseline questionnaires:

People with facial palsy: Hospital Anxiety and Depression Scale; FACE-Q Satisfaction with appearance; FACE-Q Psychological function; FACE-Q Social function and Facial Disability Index. The Facial Disability Index will allow for control of improvement in facial palsy symptoms over time.

Friends, relatives and partners: Hospital Anxiety and Depression Scale and Adult Carer Quality of Life Questionnaire.

Like the screening questionnaires, written consent and baseline questionnaires will be completed online.

Eligible participants will then be administered the relevant self-guided information and therapy guide. For eligible carers/relatives this will be the guide entitled "Facial palsy: Advice for friends, family and partners". For eligible participants with facial palsy, this will be determined by their score on the screening questionnaire.

Participants will then utilise the guide over a period of four-to-six weeks. Half-way through the intervention period (after 2-3 weeks), they will receive an email reminding them to complete the guide and will be provided a web-link to complete a questionnaire, designed for the purpose of the current study, measuring the participants' ratings of acceptability and usability of the guides (participant satisfaction questionnaire).

At the end of the four-to-six week period, participants will be re-administered the baseline questionnaires, along with a questionnaire designed for the purpose of the current study measuring the participants' ratings of acceptability and usability of the guides (participant satisfaction questionnaire). Participants with facial palsy will also be re-administered the initial screening questionnaire. This will indicate whether the participant is eligible to complete a further guide. If this is the case, then their post-intervention questionnaires will serve as a new baseline and the participant will be invited to complete the new guide over a second four-to-six week period (followed by the same follow-up assessments as followed the first guide). This process will occur up to a maximum of six times (reflecting the potential for a participant to trial all six guides). If they do not wish to complete further guides then the participant will be thanked for their involvement in the study and their involvement will be registered as 'complete'.

Friends, relatives and partners of people with facial palsy will only be required to complete pre and post questionnaires if they are actively involved in the study due to completing the friend, relative or partner ITG. Likewise, individuals with facial palsy are not required to complete questionnaires if they are not actively involved in the study (i.e. not trialing and ITG), but their friend or relative is.

The investigators aim to trial the guides over a period of one year (May 2019 - May 2020). This will lead to the predicted sample size of 140 participants (120 with facial palsy, 20 per each of the 6 guides; 20 friends and family). This target is based on there being approximately 3000 people who have access to the Facial Palsy UK website. Given that approximately one-third of people with facial palsy experience a significant level of distress; the investigators hope that our guides would be relevant to, and accessible by, around 1000 people. 140 is therefore a conservative estimate of the number of participants that the investigators will be able to recruit.

Participants recruited from OUH NHS Foundation trust will be provided with an information sheet during their clinic appointment with the Oxford Facial Palsy Service. Written consent will be obtained in the clinic by a member of the research team.

Participants recruited from social media will be provided with an information sheet via email and will provide written consent online.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual 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
• Actual Primary Completion Date: May 5, 2021
• Actual Study Completion Date: May 5, 2021

Arms and Interventions

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: Facial palsy: Coping with the early stages.; Facial palsy: Coping with comments, questions and staring.; Facial palsy: Communicating with confidence.; Facial palsy: Managing anxiety.; Facial palsy: Managing your mood.; Facial palsy: Building your self-esteem.; 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: Facial palsy: Coping with the early stages.; Facial palsy: Coping with comments, questions and staring.; Facial palsy: Communicating with confidence.; Facial palsy: Managing anxiety.; Facial palsy: Managing your mood.; Facial palsy: Building your self-esteem.; Facial palsy: Advice for friends, family and partners.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United Kingdom

John Radcliffe Hospital

Oxford, Oxon, United Kingdom, OX3 9DU

Sponsors and Collaborators

Oxford University Hospitals NHS Trust

Investigators

• Principal Investigator: Matthew Hotton; Oxford University Hospitals NHS Trust

More Information

Publications:

Fu L, Bundy C, Sadiq SA. Psychological distress in people with disfigurement from facial palsy. Eye (Lond). 2011 Oct;25(10):1322-6. doi: 10.1038/eye.2011.158. Epub 2011 Jul 1.

Coulson SE, O'dwyer NJ, Adams RD, Croxson GR. Expression of emotion and quality of life after facial nerve paralysis. Otol Neurotol. 2004 Nov;25(6):1014-9.

Muftin Z, Thompson AR. A systematic review of self-help for disfigurement: effectiveness, usability, and acceptability. Body Image. 2013 Sep;10(4):442-50. doi: 10.1016/j.bodyim.2013.07.005. Epub 2013 Aug 17. Review.

Martyn CN, Hughes RA. Epidemiology of peripheral neuropathy. J Neurol Neurosurg Psychiatry. 1997 Apr;62(4):310-8.

Hultcrantz M. Rehabilitation of Bells' palsy from a multi-team perspective. Acta Otolaryngol. 2016;136(4):363-7. doi: 10.3109/00016489.2015.1116124. Epub 2015 Dec 4. Review.

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70.

Klassen AF, Cano SJ, Alderman A, East C, Badia L, Baker SB, Robson S, Pusic AL. Self-Report Scales to Measure Expectations and Appearance-Related Psychosocial Distress in Patients Seeking Cosmetic Treatments. Aesthet Surg J. 2016 Oct;36(9):1068-78. doi: 10.1093/asj/sjw078. Epub 2016 May 24.

VanSwearingen JM, Brach JS. The Facial Disability Index: reliability and validity of a disability assessment instrument for disorders of the facial neuromuscular system. Phys Ther. 1996 Dec;76(12):1288-98; discussion 1298-300.

• Responsible Party: Matthew Hotton, Primary Investigator, Oxford University Hospitals NHS Trust
• ClinicalTrials.gov Identifier: NCT03943953
• Other Study ID Numbers: 14110
• First Posted: May 9, 2019
• Last Update Posted: July 13, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No plan to make data available

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

Additional relevant MeSH terms:

Bell Palsy; Facial Paralysis; Facies; Paralysis; Neurologic Manifestations; Nervous System Diseases; Disease Attributes; Pathologic Processes; Mouth Diseases; Stomatognathic Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Facial Nerve Diseases; Cranial Nerve Diseases