Condition category
Eye Diseases
Date applied
08/08/2013
Date assigned
08/08/2013
Last edited
06/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Trefor Aspden

ORCID ID

Contact details

Royal Holloway
Egham Hill
Egham
TW20 0EX
United Kingdom
-
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

Sponsor information

Organisation

University of London (UK)

Sponsor details

Royal Holloway
Egham Hill
Egham
TW20 0EX
United Kingdom

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes

06/01/2017: Publication reference added.