One-Day Acceptance and Commitment Training Intervention in Primary Care Patients
Condition: Mood Disorders; Hypertension; Diabetes; Hypercholesterolemia
MeSH terms: Hypercholesterolemia; Mood Disorders
Study type: Interventional

Summary: 
      The goal of this study is to 1) examine the feasibility and acceptability of a one-day
      Acceptance and Commitment Training + Illness Management (ACT-IM) intervention in patients
      with comorbid vascular disease risk factors and depression or anxiety; and 2) to evaluate the
      effectiveness of this brief group intervention(ACT-IM), compared to Treatment-As-Usual (TAU)
      on the mental health and functioning of patients with co-morbid mood/anxiety and vascular
      disease risk factors. Patients with vascular disease risk factors will be identified by
      physicians in Family Practice or Internal Medicine, through chart review, or through
      advertisements. Those with vascular risk factors will be screened and assessed for symptoms
      of depression or anxiety. Patients who are experiencing significant depressive or anxiety
      symptoms and are interested in the treatment arm of the study will be randomized to the
      ACT-IM intervention or to TAU. Assessments of the following will take place both before and
      after the intervention: depression, anxiety, functioning, illness self-management, blood
      vessel health, and blood.
    

Detailed description: 
      There is no difference in the recruitment, consent, or enrollment process for the ACT-IM or
      the TAU group.

      Patients with vascular disease risk factors will be identified by physicians in Family
      Practice or Internal Medicine, through chart review, or through advertisements. Those
      responding to advertisements or who have been referred by a physician will be invited to
      complete a screening phone call or to complete an on-line screening measure. Potentially
      eligible patients who were identified through chart review will first be sent a letter. This
      letter will be followed, at least one week later, by a phone call to assess for interest in
      the study and to provide information about the screening.

      Participants who are eligible at screening will be contacted by the research team to discuss
      the study and answer any questions the patient may have. If the patient is interested in
      participating in the treatment arm of the study, an appointment will be scheduled for an
      in-person assessment.

      At the in-person baseline assessment, participants will be provided with a detailed
      description of the study, consent will be obtained, and a 90-120 minute assessment will
      begin.

      Initial Assessment:

        -  vitals(height, weight, blood pressure, temperature, pules, respiration rate.

        -  blood draw(to test blood fat, sugars, and inflammation (lipid panel (LIPP), glucose
           (GLU), hemoglobin A1C (A1C), and hsCRP). For this blood draw we ask that the participant
           not consume alcohol for 24 hours preceding the visit. We ask that this be a 12 hour
           fasting blood draw. We also ask that the participant not take their medications the day
           of the draw, prescription or otherwise. Once the blood draw is complete, they made take
           any medications they have.

        -  Noninvasive measure of blood vessel health (finger plethysmography) using EndoPAT**.

        -  Interview: Hamilton Rating Scale for Depression and Hamilton Rating Scale for Anxiety

        -  Self Report measures

        -  Medical charts only to confirm the diagnosis of vascular disease, hypertension,
           diabetes, or obesity from the chart.

      At the end of the assessment, participants will be randomly assigned, using a 2:1 ratio, to
      either ACT-IM or TAU.

      Treatment:

      Patients in the ACT-IM group will attend a 1-day group workshop. Each ACT-IM group will be
      held at the University of Iowa Hospitals and Clinics, include 8-12 patients, and last 6
      hours. The ACT-IM group will be conducted by 2 psychologists and the IM portion will be
      completed by a physician with expertise in vascular disease-psychiatric comorbidity. Three
      broad areas will be covered: 1) Illness Management will cover the importance of physical and
      psychological self-care for the management of co-morbid depression/anxiety and vascular
      problems (e.g. fatigue, stress, poor nutrition management, and inadequate physical activity);
      2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective
      patterns of behavior and habits, ii) exploring and setting life goals and those related to
      mental and physical health, and iii) promoting effective and committed actions to achieve
      these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will
      emphasize new ways of managing troubling thoughts, feelings, and physical sensations (e.g.,
      learning how to recognize, and develop cognitive distance from unhelpful thoughts such as "I
      can't take this anymore" and learning how to willingly face experiences that cannot be
      changed). In-session exercises and practice will be heavily emphasized during the group
      intervention. A manual with information about topics covered during the group will be
      distributed for home use. Lunch will be provided and breaks will be offered to minimize
      fatigue.

      Two to four weeks after the intervention, the ACT-IM participants will be contacted by one of
      the PI's and asked to provide qualitative feedback about the workshop.

      Follow up assessments will take place at 2-, 6-, 12-, and 24-weeks. The 2-week and 6-week
      follow-ups can be completed by phone or web and take 45-60 minutes.

      The 12-week follow-up will include interview assessments of depression and anxiety and will
      be completed over the phone.

      The 24-week assessment will replicate the baseline visit. Thus, it will be an in-person
      visit, lasting 90-120 minutes.

      All interviews and interventions will be audio taped for: 1) assessment of treatment
      integrity (i.e., to ensure that therapists are following study procedures) and 2) for
      inter-rater reliability of the interview measures.

      **At baseline and 6 month follow-up, participants will undergo non-invasive testing of
      endothelial cell function using the Endothelial Peripheral Arterial Tone (EndoPAT). The
      EndoPAT is a medical device based on noninvasive Peripheral Arterial Tone (PAT)signal
      technology. It measures endothelium-mediated changes in vascular tone using unique
      bio-sensors placed on the fingertips. These changes in arterial tone are elicited by creating
      a down-stream hyperemic response induced by a standard 5-minute occlusion of the feeding
      artery (using a standard blood pressure cuff). When the cuff is released, the surge of blood
      flow causes an endothelium-dependent Flow-Mediated Dilation (FMD). The dilation or reactive
      hyperemia is captured by EndoPAT as an increase in the PAT Signal amplitude. A post-occlusion
      to pre-occlusion ratio is automatically calculated by the EndoPAT software, thus providing
      the EndoScore. Measurements from the opposite arm are used to control for concurrent
      non-endothelial dependent changes in vascular tone. Participants will be asked to clip their
      index fingernails before the visit or a research assistant may clip their fingernails before
      the study using sterilized clippers. Fingernails may need to be clipped if they are too long
      for the probes.
    

Intervention name(s): Acceptance and Commitment Therapy plus Illness Management
Intervention type(s): Behavioral
Other intervention name(s): ACT-IM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment