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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02256293
• Other study ID #: Pro00040489
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: October 1, 2014
• Last updated: June 11, 2015
• Start date: January 2015

Study information

• Verified date: September 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• Diabetes self-management group based on Acceptance and Commitment Therapy (ACT).
The group sessions will be lead by a clinician trained in Acceptance and Commitment Therapy and will meet at Duke Medical Center for 1 ½ hours once a week for a total of 8 weeks. During group sessions, participants will identify how avoidance of difficult thoughts and feelings about diabetes has interfered with diabetes management and learn alternative ways of coping with these experiences. The group sessions are intended to supplement regular medical treatment; thus it is important that subjects continue to have diabetes symptoms monitored by their current treatment provider.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability	Acceptability of treatment as measured by a post-intervention questionnaire.	8 weeks	No
Secondary	Diabetes self-management	Changes in diabetes self-management as measured by pre and post-intervention questionnaires.	8 weeks	No