Psychosocial Treatment Intervention in Persons Newly Diagnosed With Rheumatoid Arthritis or Diabetes
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|ClinicalTrials.gov Identifier: NCT01066130|
Recruitment Status : Completed
First Posted : February 10, 2010
Last Update Posted : February 10, 2010
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Arthritis, Rheumatoid Coping Skills||Behavioral: Intensive individualized psychosocial treatment Behavioral: Minimal treatment arm||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Psychosocial Treatment Intervention in Persons Newly Diagnosed With Rheumatoid Arthritis or Diabetes|
|Study Start Date :||January 2001|
|Actual Study Completion Date :||December 2005|
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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01066130
|Center for Family and Community Medicine|
|Huddinge, Sweden, 14183|
|Karolinska University Hospital Solna|
|Stockholm, Sweden, 17176|
|Principal Investigator:||Catharina M Gafvels, PhD||Karolinska Institutet|