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

NCT ID: NCT01066130

Last Updated: 2010-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31
• Study Completion Date: 2005-12-31

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.

Conditions

Diabetes Mellitus; Arthritis, Rheumatoid; Coping Skills

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intensive individualized psychosocial treatment

Intervention Type: BEHAVIORAL

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

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

Group Type: EXPERIMENTAL

Minimal treatment arm

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Minimal treatment arm

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norrbacka-Eugenia Foundation

OTHER

Sponsor Role: collaborator

Swedish Rheumatism Foundation

UNKNOWN

Sponsor Role: collaborator

Svenska Diabetes Association

UNKNOWN

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Karolinska Institutet

Principal Investigators

Catharina M Gafvels, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Center for Family and Community Medicine

Huddinge, , Sweden

Karolinska University Hospital Solna

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

Other Grant/Funding Number

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Other Grant/Funding Number

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KI DNR 00-065

Identifier Type: -

Identifier Source: org_study_id