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

June 11, 2015 updated by: Duke University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group Therapy
Diabetes self-management group based on Acceptance and Commitment Therapy (ACT).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: 8 weeks
Acceptability of treatment as measured by a post-intervention questionnaire.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes self-management
Time Frame: 8 weeks
Changes in diabetes self-management as measured by pre and post-intervention questionnaires.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Rhonda Merwin, PhD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

October 1, 2014

First Submitted That Met QC Criteria

October 1, 2014

First Posted (Estimate)

October 3, 2014

Study Record Updates

Last Update Posted (Estimate)

June 12, 2015

Last Update Submitted That Met QC Criteria

June 11, 2015

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00040489

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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