One-Day Acceptance and Commitment Training Intervention in Primary Care Patients

NCT01879800 | Completed Results

• 1 other identifier: 201207748
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mood Disorders; Hypertension; Diabetes; Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Mean Change in Participants World Health Organization Quality of Life Measure- Physical Score: Change From Baseline to 3 and 6 Month Follow-up.

  The World Health Organization Quality of Life Measure- Physical scale assesses quality of life in physical health- specifically in activities of daily living, Dependence on medicinal substances and medical aids, Energy and fatigue, Mobility, Pain and discomfort, Sleep and rest, and Work Capacity. Outcome measure will be the change from baseline, at 3, and 6 months. Each item ranges in score from 1-5. Individual items are rated on a 5 point Likert scale where 1 indicates low, negative perceptions and 5 indicates high, positive perceptions. As such, domain and facet scores are scaled in a positive direction where higher scores denote higher quality of life. The mean score of the items within this physical domain is used to calculate the overall physical domain score. Mean scores are then multiplied by 4, yielding a score of 4 to 20. A higher domain score indicates a higher quality of life in physical ability.

  Change at 3 and 6- Month Follow-up

Secondary Outcomes (2)

• Mean Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 3 and 6 Month Follow-up

  3-month and 6-Month Follow-Up

• Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 3 and 6 Month Follow-up

  3- and 6- Month Follow-Up

Study Arms (2)

Treatment As Usual/Waitlist

NO INTERVENTION

Treatment As Usual/Waitlist

Acceptance and Commitment Therapy plus Illness Management

EXPERIMENTAL

Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. 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 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 .

Behavioral: Acceptance and Commitment Therapy plus Illness Management

Interventions

Acceptance and Commitment Therapy plus Illness Management BEHAVIORAL

Also known as: ACT-IM

Acceptance and Commitment Therapy plus Illness Management

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lilian N. Dindo: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Mood Disorders; Hypertension; Diabetes Mellitus; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Mental Disorders; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Results Point of Contact

• Title: Dr. Lilian Dindo
• Organization: Baylor College of Medicine

lilian.dindo@bcm.edu

713-791-1414

Study Officials

• Lilian N Dindo, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Jess Fiedorowicz, MD, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 18, 2013
• Study Start: August 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 25, 2017
• Results First Posted: August 28, 2015

Record last verified: 2017-05

Locations

US (1)