NCT02224963

Brief Summary

The purpose of this randomized trial is to examine the effectiveness of a psycho-social "Preventive Problem Solving Intervention" on emotional well-being, change in future outlook, and vision functioning in 250 Age-related Macular Degeneration patients 60 and older.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 25, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

7.1 years

First QC Date

July 3, 2014

Last Update Submit

April 11, 2019

Conditions

Age-related Macular Degeneration

Keywords

Aging,Macular Degeneration,Preparation for Future Care,Psychological Well-being,Problem SolvingPreventionMental Health Promotion

Outcome Measures

Primary Outcomes (2)

  • Psychological Well-being

    The 42-item multidimensional Psychological Well-Being scale (PWB) will assess 6 dimensions of PWB: Autonomy, Environmental Mastery, Personal Growth, Positive Relations With Others, Purpose In Life, and Self-Acceptance. The PWB is a Likert-scored self-report measure, with anchors of "1-disagree strongly" and "6-agree strongly."

    at 16 weeks (immediately post-intervention)

  • Psychological Well-being

    The 42-item multidimensional Psychological Well-Being scale (PWB) will assess 6 dimensions of PWB: Autonomy, Environmental Mastery, Personal Growth, Positive Relations With Others, Purpose In Life, and Self-Acceptance. The PWB is a Likert-scored self-report measure, with anchors of "1-disagree strongly" and "6-agree strongly."

    at 6-month follow-up

Secondary Outcomes (2)

  • Change in Preparation for Future Care

    from baseline to 16 weeks (immediately post-intervention)

  • Preparation for Future Care

    at 6-month follow-up

Study Arms (2)

Preventive Problem-Solving Training

EXPERIMENTAL

Preventive Problem-solving Training is an adaptation of Problem-Solving Therapy that builds problem-solving skills and then focuses these skills on potential future problems. It aims to reduce avoidance of contemplation of future needs and enhance gathering information, decision-making, and concrete planning about future needs.

Behavioral: Preventive Problem-Solving Training

Life and Health Review

ACTIVE COMPARATOR

Life and Health Review is an Enhanced Attention Control that provides classes and resource information modules, just as in intervention. It differs from the intervention in that we conduct an 8-session life and health review with subjects, in which they recount life experiences from childhood to the present.

Behavioral: Life and Health Review

Interventions

Preventive Problem-Solving TrainingBEHAVIORAL

Preventive Problem-solving Training is an adaptation of Problem-Solving Therapy that builds problem-solving skills and then focuses these skills on potential future problems. It aims to reduce avoidance of contemplation of future needs and enhance gathering information, decision-making, and concrete planning about future needs.

Preventive Problem-Solving Training
Life and Health ReviewBEHAVIORAL

Life and Health Review is an Enhanced Attention Control that provides classes and resource information modules, just as in intervention. It differs from the intervention in that we conduct an 8-session life and health review with subjects, in which they recount life experiences from childhood to the present.

Life and Health Review

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of AMD
  • years and older
  • Able to communicate in English.

You may not qualify if:

  • Significant cognitive impairment at baseline (total score on Mini Mental State Exam (MMSE) for the Blind \<18, equivalent to \<21 in the regular MMSE);
  • Residence in a nursing home (assisted living facilities are acceptable);
  • Patient is acutely suicidal or psychotic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Macular DegenerationPsychological Well-Being

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesPersonal SatisfactionBehavior

Study Officials

  • Silvia Sörensen, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

July 3, 2014

First Posted

August 25, 2014

Study Start

May 1, 2009

Primary Completion

June 1, 2016

Study Completion

April 1, 2019

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

US(1)