Condition category
Eye Diseases
Date applied
08/08/2013
Date assigned
08/08/2013
Last edited
08/08/2013
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

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.
We hope 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. We propose to test an
established intervention called Problem-Solving Treatment (PST) among 120 people with
an early diagnosis of vision loss. 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. We 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, we will consider how it can be incorporated into usual care after their
diagnosis."

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

Condition

Topic: Eye; Subtopic: Eye (all Subtopics); Disease: Ophthalmology

Intervention

Problem Solving Treatment, Six sessions of Problem Solving Treatment conducted over 8 weeks, and also a telephone booster session approximately three months after the last session.

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

Publication citations

Additional files

Editorial Notes