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

This study has been completed.
Sponsor:
Collaborators:
Norrbacka-Eugenia Foundation
Swedish Rheumatism Foundation
Svenska Diabetes Association
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01066130
First received: February 9, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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


Condition Intervention
Diabetes Mellitus
Arthritis, Rheumatoid
Coping Skills
Behavioral: Intensive individualized psychosocial treatment
Behavioral: Minimal treatment arm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Psychosocial Treatment Intervention in Persons Newly Diagnosed With Rheumatoid Arthritis or Diabetes

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: January 2001
Study Completion Date: December 2005
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066130

Locations
Sweden
Center for Family and Community Medicine
Huddinge, Sweden, 14183
Karolinska University Hospital Solna
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet
Norrbacka-Eugenia Foundation
Swedish Rheumatism Foundation
Svenska Diabetes Association
Investigators
Principal Investigator: Catharina M Gafvels, PhD Karolinska Institutet
  More Information

No publications provided

Responsible Party: Catharina Gafvels, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01066130     History of Changes
Other Study ID Numbers: KI DNR 00-065, Other Grant/Funding Number, Other Grant/Funding Number
Study First Received: February 9, 2010
Last Updated: February 9, 2010
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Diabetes Mellitus
Arthritis, Rheumatoid
psychosocial aspects
Patient Adherence
Social Work
Coping Behavior
Coping Skills
Adaptation, Psychological

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Diabetes Mellitus
Autoimmune Diseases
Connective Tissue Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Joint Diseases
Metabolic Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014