Contact information
Type
Scientific
Primary contact
Dr Trefor Aspden
ORCID ID
Contact details
Royal Holloway
Egham Hill
Egham
TW20 0EX
United Kingdom
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trefor.aspden@rhul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
14289
Study information
Scientific title
A randomised controlled trial comparing the impact of problem-solving treatment and usual care on wellbeing, functional mobility and quality of life of blind and partially sighted people
Acronym
Problem Solving Treatment in Visual Impairment (POSITIVE)
Study hypothesis
People who lose their vision can have a difficult time adjusting to their condition, especially in the early stages after their diagnosis. This can have an impact on their psychological well-being and their motivation and confidence to continue with their day-to-day activities. It is hoped that helping people to develop their problem-solving skills after their initial diagnosis will increase their level of confidence and wellbeing.
Once problem-solving skills are learnt, they can also be applied to a range of problems that individuals may encounter as a person living with vision loss. The aim of this study is to test an established intervention called Problem-Solving Treatment (PST) among 120 people with an early diagnosis of vision loss.
Ethics approval
13/LO/0416
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Topic: Eye; Subtopic: Eye (all Subtopics); Disease: Ophthalmology
Intervention
A trial will be conducted where approximately half of participants will be randomly allocated to receive the intervention, and half will receive usual care. The intervention group will be split into those with severe and those with moderate to slight vision loss. The intervention consists of six sessions of Problem Solving Treatment conducted over 8 weeks, and also a telephone booster session approximately three months after the last session. The study will examine whether the intervention has a positive impact on psychological wellbeing, quality of life and mobility, and if any changes are related to severity of vision loss. If there is evidence that PST is a useful intervention for people with vision loss, the trialists will consider how it can be incorporated into usual care after diagnosis.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Warwick-Edinburgh Mental Well-being Scale; Timepoint(s): Baseline, 3 months, 6 months, 9 months
Secondary outcome measures
1. Generalized Self-efficacy Scale; Timepoint(s): Baseline, 3 months, 6 months, 9 months
2. Hospital Anxiety and Depression Scale; Timepoint(s): Baseline, 3 months, 6 months, 9 months
3. Impact of Vision Impairment Questionnaire; Timepoint(s): Baseline, 3 months, 6 months, 9 months
4. Life Spaces Questionnaire; Timepoint(s): Baseline, 3 months, 6 months, 9 months
5. Self-assessed Instrument for Perceived Visual Ability for Independent Mobility; Timepoint(s): Baseline, 3 months, 6 months, 9 months
6. Social Problem Solving Inventory Revised; Timepoint(s): Baseline, 3 months, 6 months, 9 months
7. Vision Quality of Life Index; Timepoint(s): Baseline, 3 months, 6 months, 9 months
Overall trial start date
21/06/2013
Overall trial end date
31/12/2014
Reason abandoned
Eligibility
Participant inclusion criteria
A diagnosis of severe, irreversible sight loss, or registration as blind or partially sighted within the last 3 months
Target Gender: Male & Female ; Lower Age Limit 18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 120; UK Sample Size: 120
Participant exclusion criteria
1. Already participating in psychiatric/psychological assessment or intervention within the previous 3 months
2. Having significant cognitive impairment (screened by Six-item Cognitive Impairment Test (6-CIT; Katzman et al., 1983) whereby score of =10 will result in exclusion)
3. Having insufficient proficiency in English to participate
4. Residing in a care home
Recruitment start date
21/06/2013
Recruitment end date
31/12/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Holloway
Egham Hill
Egham
TW20 0EX
United Kingdom
Funders
Funder type
Charity
Funder name
Guide Dogs for the Blind Association, UK. Ref: RFT056/10
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2014 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/25047245