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

Not Applicable

Completed

• Conditions: Arthritis, Rheumatoid; Coping Skills; Diabetes Mellitus
• Interventions: Behavioral: Intensive individualized psychosocial treatment; Behavioral: Minimal treatment arm

• Registration Number: NCT01066130
• Lead Sponsor: Karolinska Institutet

Brief Summary

The aim of this study is to evaluate the results of psychosocial treatment in patients with newly diagnosed rheumatoid arthritis and/or diabetes.

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 Timeline

• Study Start: 2001-01
• Study Completion: 2005-12
• Status Verified: 2010-02
• Study First Submitted: 2010-02-09
• Study First Submitted QC: 2010-02-09
• Last Update Submitted: 2010-02-09
• Study First Posted: 2010-02-10
• Last Update Posted: 2010-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive treatment arm	Intensive individualized psychosocial treatment	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.
Minimal treatment arm	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.

Primary Outcome Measures

Name	Time	Method
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	2 years after inclusion

Secondary Outcome Measures

Name	Time	Method
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	2 years after inclusion

Trial Locations

Locations (2)

Center for Family and Community Medicine; 🇸🇪 Huddinge, Sweden

Karolinska University Hospital Solna; 🇸🇪 Stockholm, Sweden