Self-guided Psychosocial Intervention for Facial Palsy

Facial Palsy Clinical Trial

Official title:

A Pilot Study Evaluating the Effectiveness of Information and Therapy Guides for Improving the Psychosocial Wellbeing of People With Facial Palsy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03943953
• Other study ID #: 14110
• Status: Completed
• Phase: N/A
• Start date: August 15, 2019
• Est. completion date: May 5, 2021

Study information

• Verified date: August 2022
• Source: Oxford University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: May 5, 2021
• Est. primary completion date: May 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bell Palsy
• Facial Palsy
• Facial Paralysis
• Facies

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	John Radcliffe Hospital	Oxford	Oxon

Sponsors (1)

Lead Sponsor	Collaborator
Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (8)

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. doi: 10.1097/00129492-200411000-00026. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Martyn CN, Hughes RA. Epidemiology of peripheral neuropathy. J Neurol Neurosurg Psychiatry. 1997 Apr;62(4):310-8. doi: 10.1136/jnnp.62.4.310. No abstract available. — View Citation

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. — View Citation

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. doi: 10.1093/ptj/76.12.1288. — View Citation

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FACE-Q Psychological Function	This 10-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. There is a minimum score of 10 and a maximum score of 40. Scores are Rasch transformed to a 0-100 scale. A high score indicates greater psychological wellbeing.; As some participants were eligible to trial multiple guides, some participants contributed multiple data points.	Time 1: Baseline
Primary	FACE-Q Psychological Function	This 10-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. There is a minimum score of 10 and a maximum score of 40. Scores are Rasch transformed to a 0-100 scale. A high score indicates greater psychological wellbeing.; As some participants were eligible to trial multiple guides, some participants contributed multiple data points.	Time 2: 4-6 week follow-up
Primary	FACE-Q Social Function	In this scale there are 8 statements pertaining to measuring social functioning. Scores on this scale range from 8 to 32, with scores Rasch transformed to a 0-100 scale. Higher scores indicate better social function.; As some participants were eligible to trial multiple guides, some participants contributed multiple data points.	Time 1: Baseline
Primary	FACE-Q Social Function	In this scale there are 8 statements pertaining to measuring social functioning. Scores on this scale range from 8 to 32, with scores Rasch transformed to a 0-100 scale. Higher scores indicate better social function.; As some participants were eligible to trial multiple guides, some participants contributed multiple data points.	Time 2: 4-6 week follow-up
Primary	Facial Disability Index (Social Function)	A 5-item self-report measure of social function in people with facial palsy. The scale is scored out of 100 (100 = high function).; As some participants were eligible to trial multiple guides, some participants contributed multiple data points.	Time 1: Baseline
Primary	Facial Disability Index (Social Function)	A 5-item self-report measure of social function in people with facial palsy. The scale is scored out of 100 (100 = high function).; As some participants were eligible to trial multiple guides, some participants contributed multiple data points.	Time 2: 4-6 week follow-up
Primary	FACE-Q Appearance-Related Psychosocial Distress	An eight-item scale assessing an individual's concerns regarding their facial appearance on a scale of 8-32, which is then Rasch transformed to a 0-100 scale. The higher the score, the greater the patient's dissatisfaction with their appearance.; As some participants were eligible to trial multiple guides, some participants contributed multiple data points.	Time 1: Baseline
Primary	FACE-Q Appearance-Related Psychosocial Distress	An eight-item scale assessing an individual's concerns regarding their facial appearance on a scale of 8-32, which is then Rasch transformed to a 0-100 scale. The higher the score, the greater the patient's dissatisfaction with their appearance.; As some participants were eligible to trial multiple guides, some participants contributed multiple data points.	Time 2: 4-6 week follow-up
Primary	Hospital Anxiety and Depression Scale	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. Scores range from 0-52, with a higher score indicating higher severity.; As some participants with facial palsy were eligible to trial multiple guides, some participants with facial palsy contributed multiple data points.	Time 1: Baseline
Primary	Hospital Anxiety and Depression Scale	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. Scores range from 0-52, with a higher score indicating higher severity.; As some participants with facial palsy were eligible to trial multiple guides, some participants with facial palsy contributed multiple data points.	Time 2: 4-6 week follow-up
Secondary	Adult Carer Quality of Life Questionnaire	40 item questionnaire assessing carer quality of life. Possible scores range from 0-120, with higher scores indicating higher quality of life	Time 1: Baseline
Secondary	Adult Carer Quality of Life Questionnaire	40 item questionnaire assessing carer quality of life. Possible scores range from 0-120, with higher scores indicating higher quality of life	Time 2: 4-6 week follow-up