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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Arthritis, Rheumatoid, Coping Skills

Intervention / Treatment
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* Behavioral: Intensive individualized psychosocial treatment
* Behavioral: Minimal treatment arm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive treatment arm<br>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<br>* 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.<br>|
| Experimental: Minimal treatment arm<br>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<br>* Minimal social measures were provided to individuals in this arm. No treatment that included conversational therapy was given.<br>|
| No Intervention: No need for psychosocial treatment<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 2 years after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 2 years after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Arthritis, Rheumatoid, psychosocial aspects, Patient Adherence, Social Work, Coping Behavior, Coping Skills, Adaptation, Psychological