Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01066130
Enrollment
200
Registered
2010-02-10
Start date
2001-01-31
Completion date
2005-12-31
Last updated
2010-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid, Coping Skills, Diabetes Mellitus

Keywords

Diabetes Mellitus, Arthritis, Rheumatoid, psychosocial aspects, Patient Adherence, Social Work, Coping Behavior, Coping Skills, Adaptation, Psychological

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.

Interventions

BEHAVIORALIntensive 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.

BEHAVIORALMinimal treatment arm

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

Sponsors

Norrbacka-Eugenia Foundation
CollaboratorOTHER
Swedish Rheumatism Foundation
CollaboratorUNKNOWN
Svenska Diabetes Association
CollaboratorUNKNOWN
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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 treatment2 years after inclusion

Secondary

MeasureTime frame
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 arthritis2 years after inclusion

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026