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Clinical Trials/NCT02256293
NCT02256293WithdrawnPhase 1

Acceptability and Feasibility of an ACT-Based Group to Improve Diabetes Self-Management

Duke University0 sitesStarted: January 1, 2015Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Withdrawn
Sponsor
Primary Endpoint
Acceptability

Study Overview

Brief Summary

Individuals with diabetes often report that difficult thoughts and feelings about diabetes interfere with making healthy choices with regards to diabetes management. The purpose of this study is to evaluate a diabetes self-management group based on Acceptance and Commitment Therapy (ACT). ACT is a new behavior therapy that has been found to be useful in treating psychological and behavioral difficulties. We are interested in whether individuals with diabetes will like an ACT-based diabetes management group and whether they find the group helpful.

Detailed Description

The goal of the current study is to assess the acceptability and feasibility of an acceptance-based group to improve diabetes self-management among individuals with Type 1 Diabetes. Interested individuals will participate in a weekly acceptance-based therapy group focusing on improving diabetes management (e.g., adherence to dietary recommendations, appropriate insulin dosing) for a total of 8 weeks. Participants will also be asked to complete questionnaires both pre and post treatment. Questionnaires will assess diabetes management and acceptability of the group (post treatment only). Regular medical monitoring is required for participation in the current study. Participants will be asked to provide consent to contact their current medical provider in order to confirm that the participant's is receiving regular medical monitoring for diabetes care and that providers are aware of their patient's participation in group.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 18-65
  • Diagnosed with type 1 diabetes
  • Currently monitored by a physician for their diabetes

Exclusion Criteria

  • Current or history of psychosis or mania
  • Current substance abuse
  • Non-English Speaking
  • Deficits in intellectual functioning that preclude informed consent

Outcomes

Primary Outcomes

Acceptability

Time Frame: 8 weeks

Acceptability of treatment as measured by a post-intervention questionnaire.

Secondary Outcomes

  • Diabetes self-management(8 weeks)

Investigators

Sponsor
Duke University
Sponsor Class
Other
Responsible Party
Sponsor

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