Trial Outcomes & Findings for Self-guided Psychosocial Intervention for Facial Palsy (NCT NCT03943953)

NCT ID: NCT03943953

Last Updated: 2023-07-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

97 participants

Primary outcome timeframe

Time 1: Baseline

Results posted on

2023-07-10

Participant Flow

The aim of this project was for participants to test a total of 140 Information and Therapy Guides. Because many participants were eligible to test multiple guides, the number of participants enrolled is lower than 140.

Participant milestones

Participant milestones
Measure
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. 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.
Friends and Family - ITG
In this arm of the trial friends and famileis 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. Information and Therapy Guides: Facial palsy: Advice for friends, family and partners.
Trial of ITG 1
STARTED
88
9
Trial of ITG 1
COMPLETED
69
8
Trial of ITG 1
NOT COMPLETED
19
1
Trial of ITG 2
STARTED
44
0
Trial of ITG 2
COMPLETED
36
0
Trial of ITG 2
NOT COMPLETED
8
0
Trial of ITG 3
STARTED
18
0
Trial of ITG 3
COMPLETED
16
0
Trial of ITG 3
NOT COMPLETED
2
0
Trial of ITG 4
STARTED
10
0
Trial of ITG 4
COMPLETED
8
0
Trial of ITG 4
NOT COMPLETED
2
0
Trial of ITG 5
STARTED
3
0
Trial of ITG 5
COMPLETED
3
0
Trial of ITG 5
NOT COMPLETED
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
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. 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.
Friends and Family - ITG
In this arm of the trial friends and famileis 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. Information and Therapy Guides: Facial palsy: Advice for friends, family and partners.
Trial of ITG 1
Lost to Follow-up
19
1
Trial of ITG 2
Lost to Follow-up
8
0
Trial of ITG 3
Lost to Follow-up
2
0
Trial of ITG 4
Lost to Follow-up
2
0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Facial Palsy - Trial of ITG
n=88 Participants
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. 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.
Friends and Family - Trial of ITG
n=9 Participants
In this arm of the trial friends and family 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. ITG: Facial palsy: Advice for friends, family and partners.
Total
n=97 Participants
Total of all reporting groups
Age, Continuous
46.06 years
STANDARD_DEVIATION 13.62 • n=88 Participants
45.00 years
STANDARD_DEVIATION 18.04 • n=9 Participants
45.96 years
STANDARD_DEVIATION 14.05 • n=97 Participants
Sex: Female, Male
Female
83 Participants
n=88 Participants
2 Participants
n=9 Participants
85 Participants
n=97 Participants
Sex: Female, Male
Male
5 Participants
n=88 Participants
7 Participants
n=9 Participants
12 Participants
n=97 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United Kingdom
88 participants
n=88 Participants
9 participants
n=9 Participants
97 participants
n=97 Participants
FACE-Q Psychological Function
38.19 units on a scale
STANDARD_DEVIATION 15.46 • n=88 Participants • Friends and family members did not complete this measure
38.19 units on a scale
STANDARD_DEVIATION 15.46 • n=88 Participants • Friends and family members did not complete this measure
FACE-Q Social Function
33.9 units on a scale
STANDARD_DEVIATION 18.37 • n=88 Participants • Friends and family members did not complete this measure at baseline
33.9 units on a scale
STANDARD_DEVIATION 18.37 • n=88 Participants • Friends and family members did not complete this measure at baseline
Facial Disability Index (Social Function)
49.15 units on a scale
STANDARD_DEVIATION 19.74 • n=88 Participants • Friends and family members did not complete this measure at baseline
49.15 units on a scale
STANDARD_DEVIATION 19.74 • n=88 Participants • Friends and family members did not complete this measure at baseline
FACE-Q Appearance-Related Psychosocial Distress
65.18 units on a scale
STANDARD_DEVIATION 15.53 • n=88 Participants • Friends and family members did not complete this measure at baseline
65.18 units on a scale
STANDARD_DEVIATION 15.53 • n=88 Participants • Friends and family members did not complete this measure at baseline
Hospital Anxiety and Depression Scale
18.01 units on a scale
STANDARD_DEVIATION 7.77 • n=88 Participants • Friends and family members did not complete this measure at baseline
9.33 units on a scale
STANDARD_DEVIATION 5.05 • n=9 Participants • Friends and family members did not complete this measure at baseline
17.20 units on a scale
STANDARD_DEVIATION 7.58 • n=97 Participants • Friends and family members did not complete this measure at baseline

PRIMARY outcome

Timeframe: Time 1: Baseline

Population: This measure was not collected for friends and family

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.

Outcome measures

Outcome measures
Measure
Facial Palsy - Trial of ITG
n=132 Data points
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. 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.
Friends and Family
Friends, family members and carers
FACE-Q Psychological Function
38.19 units on a scale
Standard Deviation 15.46

PRIMARY outcome

Timeframe: Time 2: 4-6 week follow-up

Population: This measure was not collected for friends and family

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.

Outcome measures

Outcome measures
Measure
Facial Palsy - Trial of ITG
n=132 Data points
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. 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.
Friends and Family
Friends, family members and carers
FACE-Q Psychological Function
41.05 units on a scale
Standard Deviation 17.68

PRIMARY outcome

Timeframe: Time 1: Baseline

Population: This measure was not collected for friends and family

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.

Outcome measures

Outcome measures
Measure
Facial Palsy - Trial of ITG
n=132 Data points
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. 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.
Friends and Family
Friends, family members and carers
FACE-Q Social Function
49.15 units on a scale
Standard Deviation 18.34

PRIMARY outcome

Timeframe: Time 2: 4-6 week follow-up

Population: This measure was not collected for friends and family

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.

Outcome measures

Outcome measures
Measure
Facial Palsy - Trial of ITG
n=132 Data points
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. 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.
Friends and Family
Friends, family members and carers
FACE-Q Social Function
53.03 units on a scale
Standard Deviation 20.43

PRIMARY outcome

Timeframe: Time 1: Baseline

Population: This measure was not collected for friends and family

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.

Outcome measures

Outcome measures
Measure
Facial Palsy - Trial of ITG
n=132 Data points
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. 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.
Friends and Family
Friends, family members and carers
Facial Disability Index (Social Function)
49.15 units on a scale
Standard Deviation 19.74

PRIMARY outcome

Timeframe: Time 2: 4-6 week follow-up

Population: This measure was not collected for friends and family

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.

Outcome measures

Outcome measures
Measure
Facial Palsy - Trial of ITG
n=132 Data points
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. 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.
Friends and Family
Friends, family members and carers
Facial Disability Index (Social Function)
53.03 units on a scale
Standard Deviation 20.43

PRIMARY outcome

Timeframe: Time 1: Baseline

Population: This measure was not collected for friends and family

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.

Outcome measures

Outcome measures
Measure
Facial Palsy - Trial of ITG
n=132 Data points
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. 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.
Friends and Family
Friends, family members and carers
FACE-Q Appearance-Related Psychosocial Distress
65.18 units on a scale
Standard Deviation 15.53

PRIMARY outcome

Timeframe: Time 2: 4-6 week follow-up

Population: This measure was not collected for friends and family

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.

Outcome measures

Outcome measures
Measure
Facial Palsy - Trial of ITG
n=132 Data points
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. 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.
Friends and Family
Friends, family members and carers
FACE-Q Appearance-Related Psychosocial Distress
62.90 units on a scale
Standard Deviation 15.03

PRIMARY outcome

Timeframe: Time 1: Baseline

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.

Outcome measures

Outcome measures
Measure
Facial Palsy - Trial of ITG
n=132 Data points
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. 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.
Friends and Family
n=8 Data points
Friends, family members and carers
Hospital Anxiety and Depression Scale
18.01 units on a scale
Standard Deviation 7.77
10.00 units on a scale
Standard Deviation 4.96

PRIMARY outcome

Timeframe: Time 2: 4-6 week follow-up

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.

Outcome measures

Outcome measures
Measure
Facial Palsy - Trial of ITG
n=132 Data points
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. 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.
Friends and Family
n=8 Data points
Friends, family members and carers
Hospital Anxiety and Depression Scale
17.61 units on a scale
Standard Deviation 8.12
9.25 units on a scale
Standard Deviation 4.65

SECONDARY outcome

Timeframe: Time 1: Baseline

Population: This measure was not collected for people with facial palsy

40 item questionnaire assessing carer quality of life. Possible scores range from 0-120, with higher scores indicating higher quality of life

Outcome measures

Outcome measures
Measure
Facial Palsy - Trial of ITG
n=8 Participants
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. 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.
Friends and Family
Friends, family members and carers
Adult Carer Quality of Life Questionnaire
56.88 units on a scale
Standard Deviation 10.02

SECONDARY outcome

Timeframe: Time 2: 4-6 week follow-up

Population: This measure was not collected for people with facial palsy

40 item questionnaire assessing carer quality of life. Possible scores range from 0-120, with higher scores indicating higher quality of life

Outcome measures

Outcome measures
Measure
Facial Palsy - Trial of ITG
n=8 Participants
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. 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.
Friends and Family
Friends, family members and carers
Adult Carer Quality of Life Questionnaire
64.88 units on a scale
Standard Deviation 10.06

Adverse Events

Facial Palsy - Trial of ITG

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Friends and Family

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Matthew Hotton

Oxford University Hospitals NHS Foundation Trust

Phone: 01865 234714

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place