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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01066130
• Other study ID #: KI DNR 00-065
• Secondary ID: Other Grant/Fund
• Status: Completed
• Phase: N/A
• First received: February 9, 2010
• Last updated: February 9, 2010
• Start date: January 2001
• Est. completion date: December 2005

Study information

• Verified date: February 2010
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Coping Skills
• Diabetes Mellitus

Intervention

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.
• Minimal treatment arm
Minimal social measures were provided to individuals in this arm. No treatment that included conversational therapy was given.

Locations

Country	Name	City	State
Sweden	Center for Family and Community Medicine	Huddinge
Sweden	Karolinska University Hospital Solna	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska Institutet	Norrbacka-Eugenia Foundation, Svenska Diabetes Association, Swedish Rheumatism Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No