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

Phase 1

Withdrawn

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Behavioral: Diabetes self-management group based on Acceptance and Commitment Therapy (ACT).

• Registration Number: NCT02256293
• Lead Sponsor: Duke University

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 Timeline

• Status Verified: 2014-09
• Study First Submitted: 2014-10-01
• Study First Submitted QC: 2014-10-01
• Study First Posted: 2014-10-03
• Study Start: 2015-01
• Last Update Submitted: 2015-06-11
• Last Update Posted: 2015-06-12
• Primary Completion: 2016-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group Therapy	Diabetes self-management group based on Acceptance and Commitment Therapy (ACT).	Diabetes self-management group based on Acceptance and Commitment Therapy (ACT).

Primary Outcome Measures

Name	Time	Method
Acceptability	8 weeks	Acceptability of treatment as measured by a post-intervention questionnaire.

Secondary Outcome Measures

Name	Time	Method
Diabetes self-management	8 weeks	Changes in diabetes self-management as measured by pre and post-intervention questionnaires.