N/A N=97 Treatment

Self-guided Psychosocial Intervention for Facial Palsy

Facial Palsy

Bottom Line

View on ClinicalTrials.gov: NCT03943953 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2023

Primary outcome: Primary: FACE-Q Psychological Function — 38.19 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Information and Therapy Guides (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Oxford University Hospitals NHS Trust
Primary completion: May 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY FACE-Q Psychological Function	41.05	.018 sig
PRIMARY FACE-Q Psychological Function	41.05	.018 sig
PRIMARY FACE-Q Social Function	53.03	.001 sig
PRIMARY FACE-Q Social Function	53.03	.001 sig
PRIMARY Facial Disability Index (Social Function)	53.03	.006 sig
PRIMARY Facial Disability Index (Social Function)	53.03	.006 sig
PRIMARY FACE-Q Appearance-Related Psychosocial Distress	62.90	.035 sig
PRIMARY FACE-Q Appearance-Related Psychosocial Distress	62.90	.035 sig
PRIMARY Hospital Anxiety and Depression Scale	17.61; 9.25	.39
PRIMARY Hospital Anxiety and Depression Scale	17.61; 9.25	.39
SECONDARY Adult Carer Quality of Life Questionnaire	64.88	—
SECONDARY Adult Carer Quality of Life Questionnaire	64.88	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03943953). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.