N/A
Completed N=44
One-Day Acceptance and Commitment Training Intervention in Primary Care Patients
Source: ClinicalTrials.gov NCT01879800 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcomePrimary: Mean Change in Participants World Health Organization Quality of Life Measure- Physical Score: Change From Baseline to 3 and 6 Month Follow-up. — .85; 2.8; 1.9; 4.1 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Participants World Health Organization Quality of Life Measure- Physical Score: Change From Baseline to 3 and 6 Month Follow-up. |
.85; 2.8; 1.9; 4.1 | — |
| SECONDARY Mean Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 3 and 6 Month Follow-up |
-2.8; -9.9; -.8; -11.7 | — |
| SECONDARY Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 3 and 6 Month Follow-up |
-2.8; -12.2; 0; -12.7 | — |
Eligibility Criteria
Inclusion Criteria
- The subject population is people ages 18-75 who have vascular risk factors (hypertension, diabetes mellitus or impaired fasting glucose, dyslipidemia, or obesity) and symptoms of depression or anxiety. Symptoms of depression and anxiety will be operationally defined as a score of >= 10 on the Patient Health Questionnaire (PHQ-8;depression) or GAD-7 (anxiety). All participants must be English speaking.
Exclusion Criteria
- Patients with a primary psychotic disorder (e.g. schizophrenia).
- Patients with current alcohol or illicit drug dependence/abuse disorders.
- Patients who have started a new medication in previous 4 weeks or plan on starting a new medication in the next 4 weeks.
- Patients expressing active suicidal ideation.
Data sourced from ClinicalTrials.gov (NCT01879800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.