Psychosocial Treatment Intervention in Persons Newly Diagnosed With Rheumatoid Arthritis or Diabetes

February 9, 2010 updated by: Karolinska Institutet
The aim of this study is to evaluate the results of psychosocial treatment in patients with newly diagnosed rheumatoid arthritis and/or diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Research and clinical experience show that adaptation to chronic disease is affected by individuals' psychological and social situations and subjective experiences of threat to identity, autonomy, and life. It is important to identify persons whose psychosocial situation and reaction to the diagnosis is such that they may not be able to adjust to the illness or take adequate responsibility for adherence to treatment.

The purpose of this study is to identify such at-risk persons, and with the help of psychosocial treatment, strengthen their resistance resources and help them work through emotional and social problems that hinder adequate adaptation and adherence to treatment.

Beginning in 2001, 200 consecutive patients between 18 and 65 years who are newly diagnosed with either rheumatoid arthritis (n = 100) or diabetes (n = 100) at the Karolinska Hospital, Solna, Sweden, will be included in the study. Each person will be interviewed by a medical social worker about their psychosocial situation and possible problems. Every other patient with psychosocial problems will be offered intensive, personalized psychosocial treatment. The rest of the patients with problems will be given minimal required measures. The psychosocial well-being and medical situation of all patients (intensive treatment group, minimal treatment group, and the group without need of psychosocial measures) will be followed for 2 years and evaluated at the conclusion of that time.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Huddinge, Sweden, 14183
        • Center for Family and Community Medicine
      • Stockholm, Sweden, 17176
        • Karolinska University Hospital Solna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • newly diagnosed diabetes (within one month of receiving diagnosis)
  • newly diagnosed rheumatoid arthritis(within one month of receiving diagnosis)
  • patient at the endocrinological or rheumatical clinic at the Karolinska University Hospital, Solna, Sweden

Exclusion Criteria:

  • patients previously diagnosed with diabetes (had been diagnosed more than a month ago)
  • patients previously diagnosed with rheumatoid arthritis (had been diagnosed more than a month ago)
  • inability to speak Swedish well enough to fill in standard questionnaires

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive treatment arm
Every second person with psychosocial problems was randomized into this arm. The intervention consisted of personalized, intensive psychosocial treatment provided by a medical social worker on the basis of the patient's problems for up to 2 years after inclusion.
Behavioral: Intensive individualized psychosocial treatment
Each person was given psychosocial treatment and support by a medical social worker a maximum of one time each week for a period of up to 2 years after inclusion. Treatment was designed by a medical social work on the basis of the individual's personal needs.
Experimental: Minimal treatment arm
Every second patient with psychosocial problems was assigned to this arm. Patients in this arm received minimal social support by a medical social worker.
Behavioral: Minimal treatment arm
Minimal social measures were provided to individuals in this arm. No treatment that included conversational therapy was given.
No Intervention: No need for psychosocial treatment
This arm consisted of individuals who did not need psychosocial treatment or measures. The need for such treatment and measures was determined at baseline for all persons included in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Psychosocial well-being as measured by interview with a medical social worker, Hospital Anxiety and Depression Scale, General Coping Questionnaire, Social Situation Questionnaire, and self-reported satisfaction with psychosocial treatment
Time Frame: 2 years after inclusion
2 years after inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Medical parameters that show whether the patient has reached treatment goals for his or her disease; for example, glycated hemoglobin (HbA1c) for diabetes and the Disease Activity Score (DAS) for rheumatoid arthritis
Time Frame: 2 years after inclusion
2 years after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Norrbacka-Eugenia Foundation
Swedish Rheumatism Foundation
Svenska Diabetes Association

Investigators

  • Principal Investigator: Catharina M Gafvels, PhD, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

February 9, 2010

First Submitted That Met QC Criteria

February 9, 2010

First Posted (Estimate)

February 10, 2010

Study Record Updates

Last Update Posted (Estimate)

February 10, 2010

Last Update Submitted That Met QC Criteria

February 9, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KI DNR 00-065
  • Other Grant/Funding Number (Other Grant/Funding Number: Reumatikerfonden D:nr 45/05)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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