Acceptability and Feasibility of an ACT-Based Group to Improve Diabetes Self-Management
Primary Purpose
Type 1 Diabetes Mellitus
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Diabetes self-management group based on Acceptance and Commitment Therapy (ACT).
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group Therapy
Arm Description
Diabetes self-management group based on Acceptance and Commitment Therapy (ACT).
Outcomes
Primary Outcome Measures
Acceptability
Acceptability of treatment as measured by a post-intervention questionnaire.
Secondary Outcome Measures
Diabetes self-management
Changes in diabetes self-management as measured by pre and post-intervention questionnaires.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02256293
Brief Title
Acceptability and Feasibility of an ACT-Based Group to Improve Diabetes Self-Management
Official Title
Acceptability and Feasibility of an ACT-Based Group to Improve Diabetes Self-Management
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Withdrawn
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group Therapy
Arm Type
Experimental
Arm Description
Diabetes self-management group based on Acceptance and Commitment Therapy (ACT).
Intervention Type
Behavioral
Intervention Name(s)
Diabetes self-management group based on Acceptance and Commitment Therapy (ACT).
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability
Description
Acceptability of treatment as measured by a post-intervention questionnaire.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Diabetes self-management
Description
Changes in diabetes self-management as measured by pre and post-intervention questionnaires.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rhonda Merwin, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Acceptability and Feasibility of an ACT-Based Group to Improve Diabetes Self-Management
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