| Study Aims
- To assess the feasibility of recruitment and retention of
type 2 diabetes patients in the community to the study protocol;
- To assess improvements in depression from baseline to follow-up
assessment (post-intervention and 3-month follow-up);
- To assess improvements in diabetes outcomes (HbA1c) from
baseline to follow-up assessment;
- To assess improvements in cardiovascular risk factors from
baseline to follow-up.
Inclusion Criteria
- Patients with type 2 diabetes with 1 year duration or longer
- Current depressive episode (resulting in clinical impairment)
- Individuals for whom routine exercise is appropriate and
recommended
- Medically stable individuals
Exclusion Criteria
- Lifetime history of stroke
- History of MI, stent placement, CABG or aortic stenosis in
the past year.
- History of laser treatment for proliferative retinopathy
in the past 6 months
- Lower extremity amputation
- Uncontrolled stage II hypertension
What was the Program ACTIVE Intervention?
Participants in Program ACTIVE engaged in two primary forms of
intervention: 12-weeks of community-based exercise and 10-sessions
of cognitive behavioral therapy. Both interventions were designed
to behaviorally activate participants and provided them with problem-solving
tools to better manage depression and diabetes symptoms.
In the exercise component, participants were provided with 6 exercise
training classes conducted by Michael Kushnick, Ph.D., an exercise
physiologist. Participants received training to monitor heart rate,
blood glucose and make adjustments to their exercise regimen during
each session. Safety guidelines for exercise (e.g. correct procedures
for warm-up and cool-down periods) as well as orientation to various
exercise equipment was provided.
Participants were also provided with pedometers and glucometers
to monitor steps and glucose values pre- and post-exercise. Participants
were given goals to engage in physical activity up to 150 minutes
per week. Participants were given a supplemental manual on the
behavioral and motivational aspects of creating and maintaining
an exercise routine.
Participants in the CBT intervention met with student therapists
10 times over the 12-week intervention period. Therapists used
standard CBT tools to set treatment goals, identify and problem-solve
problem behaviors, identify cognitive distortions and negative
automatic thoughts and explore depressogenic core beliefs. Participants
received a CBT treatment manual and prepare take-home activities
each week on these topics.
In addition, participants were provided “toolbox”
materials that were designed to encourage participants to engage
in routine physical activities.
See some examples of our intervention materials…
Program ACTIVE Results
Patients (Ps) with type 2 diabetes (T2DM) are twice as likely to experience depression (MDD) as non-T2DM peers. In this population, MDD contributes to decreased self-efficacy (SE) and diabetes quality of life (DQOL), negatively impacts social support and resources for chronic-illness management (CIRS), and reduces self-care behaviors (e.g., exercise).
Program ACTIVE was a single-arm repeated measures trial designed to test the effectiveness of a novel combination of community-based exercise (12 wks) and cognitive behavioral therapy (CBT; 10 sessions) treatment on MDD in rural T2DM Appalachians. This study asked if improvements could be seen in depressive symptoms (BDI), SE, DQOL, CIRS, exercise-related stage of change (SOC), and exercise in this rigorous intervention. Outcome variables were measured at baseline, post-intervention (POST) and 3-month follow-up (3MFU).
Ps (N=50) were 68% female, 74% married, and had a mean age of 57 (S.D. 9). The modal income was $21-40,000/yr. Mean duration of T2DM was 11 yrs (S.D. 7) and mean BMI was 35.1 (S.D. 7.1).
Using intent-to-treat analyses, mean BDI scores improved at POST (p<.01) and 3MFU (p<.01). Mean BDI scores dropped from moderate/severe to mild levels at POST (M=16.7, S.D. 13) and 3MFU (M=17.5, S.D. 12.1). DQOL and CIRS improved at POST (M=5.9, S.D. 8.8, p<.01; M=7.9, S.D. 12, p<.01 respectively) and 3MFU (M=5.5, S.D. 7.7, p<.01; M=2.1, S.D. 11.4 respectively).
Evaluation of exercise SOC showed that Ps moved from the preparation to action stage at POST. Ps completed 193 min/wk of aerobic activity (range: 76-478) during the intervention exceeding the 150 min/wk goal. Self-reported exercise improved significantly at POST (11.9, S.D. 18.5, p<.01) and 3MFU (10.2, S.D. 16.6, p<.01). Ps reported increased SE from baseline to POST (M=5.9, S.D. 13.6, p<.05).
This study demonstrated that significant improvements can be gained in quality of life, social support, and exercise-related self-efficacy in a rigorous combination treatment approach for depression among Appalachians with T2DM.
How Much Does the Program Cost?
Program ACTIVE was FREE for people who qualify and join the study.
Participants received the following:
- Cardiac stress test
- Pedometer to measure the number of steps you walk each day
- Glucometer and test strips to measure your blood sugars
- Access to the area exercise facilities
- Medical Exam
- 10 sessions of talk therapy
Were There Any Risks to Participants Who
Joined Program ACTIVE?
Study investigators took special precautions to minimize risks
to participants. Minor risk was associated with the collection
of blood samples which were requested over the course of the study.
There was also minor risk of discomfort for some who attended talk
therapy sessions.
Long-Term Goals of Program ACTIVE
Program ACTIVE was designed to serve as a pilot and feasibility
study that will inform the creation of a large-scale study to
be submitted for funding from NIDDK. Infrastructure created in
this current study as well as scientific findings will be used
in the design of the larger project. The long-term goal of Program
ACTIVE is to create a self-sufficient diabetes and depression
treatment program in the community beyond the period of federal
funding.
Materials Available for Physicians
Program ACTIVE was designed with busy physician practices
in mind. We provided colleagues with:
- Exam room posters (click here
for an example)
- Waiting room flyers (click here
for an example)
- Letter templates to announce the study to eligible patients
(click here
for an example)
|
Yes, I would like to be a referral source
for a future version of Program ACTIVE!
(click here
for a link that would send us an
email)
|
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