Self-guided Psychosocial Intervention for Facial Palsy

NCT03943953 | Completed Results

• 1 other identifier: 14110
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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

Conditions

Facial Palsy

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Adult Carer Quality of Life Questionnaire

  Time 1: Baseline

• Adult Carer Quality of Life Questionnaire

  Time 2: 4-6 week follow-up

Study Arms (1)

Facial Palsy - Trial of ITG

EXPERIMENTAL

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

Interventions

Information and Therapy Guides BEHAVIORAL

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.

Facial Palsy - Trial of ITG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (1)

John Radcliffe Hospital

Oxford, Oxon, OX3 9DU, United Kingdom

Location

Related Publications (9)

• 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.

  PMID: 21720412 BACKGROUND

• 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.

  PMID: 15547436 BACKGROUND

• 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.

  PMID: 23962642 BACKGROUND

• 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.

  PMID: 9120441 BACKGROUND

• 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.

  PMID: 26634395 BACKGROUND

• 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.

  PMID: 6880820 BACKGROUND

• 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.

  PMID: 27222106 BACKGROUND

• 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.

  PMID: 8959998 BACKGROUND

• Hotton M, Johnson D, Kilcoyne S, Dalton L. Evaluating the effectiveness and acceptability of information and therapy guides for improving the psychosocial well-being of people with facial palsy. J Plast Reconstr Aesthet Surg. 2022 Sep;75(9):3356-3364. doi: 10.1016/j.bjps.2022.04.022. Epub 2022 Apr 25.

  PMID: 35623976 DERIVED

MeSH Terms

Conditions

Facial Paralysis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

* Over representation of female participants * Small number of participants trialling each guide meant guides were evaluated collectively * 31 participants were lost to follow-up, partly due to the suspension of the trial due to Covid-19 * No randomisation or control group was included.

Results Point of Contact

• Title: Dr Matthew Hotton
• Organization: Oxford University Hospitals NHS Foundation Trust

matthew.hotton@ouh.nhs.uk

01865 234714

Study Officials

• Matthew Hotton

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: One single group will be trialling a new self-guided psychological intervention

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 9, 2019
• Study Start: August 15, 2019
• Primary Completion: May 5, 2021
• Study Completion: May 5, 2021
• Last Updated: July 10, 2023
• Results First Posted: July 10, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)