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

NCT ID: NCT02256293

Last Updated: 2015-06-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group Therapy

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rhonda Merwin, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Other Identifiers

Pro00040489

Identifier Type: -

Identifier Source: org_study_id