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

Karolinska Institute

Status: Completed

Conditions: Diabetes Mellitus; Coping Skills; Arthritis, Rheumatoid

Treatments: Behavioral: Intensive individualized psychosocial treatment; Behavioral: Minimal treatment arm

Study type: Interventional

Funder types: Other

Identifiers

NCT01066130

KI DNR 00-065

Other Grant/Funding Number (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 3 patient groups

Intensive treatment arm

Experimental group

Description:

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.

Treatment:

Behavioral: Intensive individualized psychosocial treatment

Minimal treatment arm

Experimental group

Description:

Every second patient with psychosocial problems was assigned to this arm. Patients in this arm received minimal social support by a medical social worker.

Treatment:

Behavioral: Minimal treatment arm

No need for psychosocial treatment

No Intervention group

Description:

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.