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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Withdrawn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
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 1, 2014
    Last Updated
    June 11, 2015
    Sponsor
    Duke University
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    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    Withdrawn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

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

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