NCT02256293

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Last Updated

June 12, 2015

Status Verified

September 1, 2014

Enrollment Period

1 year

First QC Date

October 1, 2014

Last Update Submit

June 11, 2015

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Acceptability

    Acceptability of treatment as measured by a post-intervention questionnaire.

    8 weeks

Secondary Outcomes (1)

  • Diabetes self-management

    8 weeks

Study Arms (1)

Group Therapy

EXPERIMENTAL

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

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

Interventions

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

Group Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65
  • Diagnosed with type 1 diabetes
  • Currently monitored by a physician for their diabetes

You may not qualify if:

  • Current or history of psychosis or mania
  • Current substance abuse
  • Non-English Speaking
  • Deficits in intellectual functioning that preclude informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Rhonda Merwin, PhD

    Duke University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2014

First Posted

October 3, 2014

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Last Updated

June 12, 2015

Record last verified: 2014-09