ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes

Part of paid clinical trials in San Diego, California.

Sponsor
Scripps Whittier Diabetes Institute
Study ID
NCT04933851
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ACT1VATE — BEHAVIORAL
    ACT1VATE, informed by Acceptance and Commitment Therapy (ACT), will consist of five, 90-minute group-based telemedicine therapy sessions delivered by a Behavioral Health Provider.
  • DSME/S — BEHAVIORAL
    Diabetes self-management education and support (DSME/S) will be delivered by a Certified Diabetes Care and Education Specialist via one-on-one telemedicine format.

Study Details

This research will compare a psychological intervention ("ACT1VATE") versus diabetes self-management education and support (DSME/S; usual care) in improving clinical, behavioral, psychosocial, process, and cost outcomes among adults with poorly controlled type 1 diabetes (T1D) who are experiencing significant diabetes-related emotional distress and poor glycemic control in a real world, healthcare environment.

Key Dates

Start date
Oct 25, 2021
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ACT1VATE
    Participants assigned to the intervention group will be offered a psychological intervention specifically designed to address diabetes-related emotional distress.
  • Active Comparator: DSME/S (usual care)
    Participants randomized to the usual care group will be offered standard diabetes self-management education and support (DSME/S).

Primary Outcome Measure

Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Scripps Whittier Diabetes InstituteSan DiegoCalifornia92121
Addie Fortmann, PhD
[email protected]
858-922-2276

Find similar trials in San Diego, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Scripps Whittier Diabetes Institute· San Diego, CA

Related Studies