NCT01786083

Brief Summary

The purpose of this study is to evaluate the effectiveness of the Problem Solving Technique (PST) in reducing symptoms of anxiety and depression among primary caregivers of chronically ill patients. And also to describe and evaluate the process carried out by nurses when implementing the PST as a useful tool for care for family caregivers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2007

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

September 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

2 years

First QC Date

February 1, 2013

Last Update Submit

February 7, 2013

Conditions

Keywords

family caregiversdependencyProblem Solving Techniquehome based nursing

Outcome Measures

Primary Outcomes (3)

  • Anxiety

    Goldberg Scale

    Two years

  • Depression

    Goldberg scale

    Two years

  • perceived wellbeing levels

    Primary caregiver's Emotional health(NOC 2506)

    two years

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

Application of Problem Solving Technique

Behavioral: Application of Problem Solving Technique

No counseling

NO INTERVENTION

Usual care by caregiver

Interventions

Lifestyle counseling

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Caregivers of chronically ill patients included in the ATDOM programme, who at the time of the intervention had a positive score on the Goldberg scale for anxiety and/or depression.

You may not qualify if:

  • Professional caregivers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Health Centers, Tarragona Province

Tarragona, Tarragona, 43000, Spain

Location

Related Links

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2013

First Posted

February 7, 2013

Study Start

September 1, 2007

Primary Completion

September 1, 2009

Study Completion

July 1, 2011

Last Updated

February 8, 2013

Record last verified: 2013-02

Locations