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
| ISRCTN | ISRCTN87854656 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87854656 |
| Secondary identifying numbers | 14289 |
- Submission date
- 08/08/2013
- Registration date
- 08/08/2013
- Last edited
- 06/01/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Trefor Aspden
Scientific
Scientific
Royal Holloway
Egham Hill
Egham
TW20 0EX
United Kingdom
| trefor.aspden@rhul.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| Study acronym | Problem Solving Treatment in Visual Impairment (POSITIVE) |
| Study objectives | 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(s) | 13/LO/0416 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 21/06/2013 |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 120; UK Sample Size: 120 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 21/06/2013 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Holloway
Egham Hill
Egham
TW20 0EX
United Kingdom
Egham
TW20 0EX
United Kingdom
Sponsor information
University of London (UK)
University/education
University/education
Royal Holloway
Egham Hill
Egham
TW20 0EX
England
United Kingdom
"ROR" |
https://ror.org/04cw6st05 |
|---|
Funders
Funder type
Charity
Guide Dogs for the Blind Association, UK. Ref: RFT056/10
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/07/2014 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
06/01/2017: Publication reference added.
