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Psychoeducational Approach to Improve Health in Lupus

Mass General Brigham logo

Mass General Brigham

Status and phase

Completed
Phase 2

Conditions

Systemic Lupus Erythematosus

Treatments

Procedure: Counseling intervention
Device: Informational film

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00000417
P60AR036308 (U.S. NIH Grant/Contract)
P60 AR36308 NIAMS-014

Details and patient eligibility

About

We will study the relationships among patient/partner communication, social support, and self-efficacy (a person's belief in the ability to manage his or her disease) as they affect the health of people with systemic lupus erythematosus (SLE, or lupus) over time. We are assigning 150 people with lupus and their partners to either (1) receive counseling to improve self-efficacy, partner support, and patient/partner problem solving or (2) see an informational film about lupus. We will follow study participants for 12 months to find out about their physical and mental health, disease activity, beliefs that they can take steps that help them feel better, coping, social support, and couples communication.

Full description

Studies have shown that patient self-efficacy in disease management and social support predict physical and mental health and disease activity in lupus. We wished to study the relationships among patient/partner communication, social support, and self-efficacy as they influence patient health longitudinally. We are randomizing 150 lupus patients and their partners to either (1) participate in a counseling intervention to improve self-efficacy, partner support, and patient/partner problem-solving in lupus management or (2) see an informational film about lupus (control). The counseling intervention includes an initial in-person session followed by five monthly telephone calls to monitor and reinforce problem-solving. We will follow patients for 12 months for self-reported physical and mental health, disease activity, self-efficacy, coping, social support, and couples communication.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Has partner willing to participate in study

Exclusion criteria

  • Unable to read and write English questionnaires
  • Unable to be reached by phone
  • Rheumatologist considers patient unable to participate, generally due to patient cognitive problems or severe illness

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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