Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adapted ACHIEVE Curriculum for Community Mental Health Settings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03999892
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : July 3, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
In light of the obesity epidemic in persons with serious mental illness (SMI), there is an urgent need to scale-up behavioral interventions that have demonstrated efficacy in the clinical trial setting such as the intervention in the National Institute of Mental Health (NIMH)-funded Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE) trial. To increase ease of adoption and sustained implementation of ACHIEVE in community mental health programs, the format needs to be adapted for delivery by community mental health staff. Based on the investigators' experience conducting the ACHIEVE trial, this study team had modified the ACHIEVE intervention into a new ACHIEVE curriculum appropriate for community mental health settings. Therefore, the investigators will pilot test 8 weeks of this curriculum in a community-based psychiatric rehabilitation program (PRP) to determine whether this format is acceptable to participating PRP consumers with SMI as well as PRP staff and peer leaders.

Condition or disease Intervention/treatment Phase
Obesity Mental Disorders, Severe Behavioral: ACHIEVE Not Applicable

Detailed Description:
Prevalence of obesity is significantly elevated and a leading cause of preventable death in people with serious mental illness (SMI) through its effects on other cardiovascular disease (CVD) risk factors and CVD. Behavioral interventions targeting changes in diet and exercise need to be tailored to the needs of people with SMI, such as memory impairment and limited executive function. The NIMH-funded Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE) trial tested a behavioral weight-loss intervention for persons with SMI and demonstrated clinically significant weight loss. In light of the obesity epidemic in persons with SMI, there is an urgent need to scale-up interventions like ACHIEVE. To increase ease of adoption and sustained implementation of ACHIEVE in community mental health programs, the format needs to be adapted for delivery by community mental health staff. Based on the investigators' experience conducting the ACHIEVE trial, this study team had modified the ACHIEVE intervention into a new ACHIEVE curriculum appropriate for community mental health settings. Therefore, the investigators will pilot test 8 weeks of this curriculum in a community-based psychiatric rehabilitation program (PRP) to determine whether this format is acceptable to participating PRP consumers with SMI as well as PRP staff and peer leaders.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ACHIEVE-D Pilot Study
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Consumers with SMI
Consumers with serious mental illness who attend a psychiatric rehabilitation program (PRP) will participate in a group-based diet and physical activity program.
Behavioral: ACHIEVE
The investigators will test two modules of the adapted video-assisted curriculum format of 45 to 60-minute multipurpose classes, which will include a segment on group weight management (~20-30 minutes) and group exercise (~20-30 minutes). Within each module, the group weight management topic varies by week, and within each week the content of the three weight management groups builds gradually and is purposely repeated. Within each module, the group exercise classes will focus on mild to moderate intensity aerobic exercise using an exercise video. In this pilot study, a trained study interventionist will deliver the ACHIEVE-D curriculum.

Staff at PRP
Staff and peer leaders who work at a psychiatric rehabilitation program (PRP) will observe sessions of a group-based diet and physical activity program for consumers with SMI.
Behavioral: ACHIEVE
The investigators will test two modules of the adapted video-assisted curriculum format of 45 to 60-minute multipurpose classes, which will include a segment on group weight management (~20-30 minutes) and group exercise (~20-30 minutes). Within each module, the group weight management topic varies by week, and within each week the content of the three weight management groups builds gradually and is purposely repeated. Within each module, the group exercise classes will focus on mild to moderate intensity aerobic exercise using an exercise video. In this pilot study, a trained study interventionist will deliver the ACHIEVE-D curriculum.




Primary Outcome Measures :
  1. Consumer satisfaction with ACHIEVE curriculum as assessed by two open-ended questions at focus group discussion [ Time Frame: One week post-intervention ]
    We will ask two open-ended questions during a focus group discussion with consumers to determine their satisfaction with the curriculum. Responses will be categorized into various levels of satisfaction.

  2. Consumer attitudes towards the ACHIEVE curriculum as assessed by five open-ended questions at focus group discussion [ Time Frame: One week post-intervention ]
    We will ask five open-ended questions during a focus group discussion with consumers to determine their attitudes towards the curriculum and its components. Responses will be categorized into various attitudes.

  3. Staff attitudes towards the ACHIEVE curriculum as assessed by seven open-ended questions at focus group discussion [ Time Frame: One-week post-intervention ]
    We will ask seven open-ended questions during a focus group discussion with staff to determine their attitudes towards the curriculum and its components. Responses will be categorized into various attitudes.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged 18 or older
  • consumers at Prologue psychiatric rehabilitation program
  • expected to be in the rehabilitation program for at least 6 months after enrollment
  • able to attend the intervention classes 3 days per week
  • able and willing to give informed consent and participate in the intervention
  • have a body mass index (BMI) over 25 kg/m2
  • be interested in losing weight

Exclusion Criteria:

  • any underlying medical conditions that could seriously reduce life expectancy, ability to participate in the study, or for which dietary change or physical activity may be contraindicated and/or require medical supervision by a physician (e.g., medication-dependent diabetes mellitus, cancer or malignant tumor, lung disease requiring supplemental oxygen, dementia or cognitive impairment, consumption of more than 14 drinks per week, eating disorders, angina, or diagnosis in the last 12 months of myocardial infarction, congestive heart failure, transient ischemic attack or stroke, liver disease or kidney disease)
  • women who are pregnant or breastfeeding
  • individuals with an inability to walk to participate in exercise class as demonstrated by walking up and down 2 flights of stairs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03999892


Contacts
Layout table for location contacts
Contact: Joe Gennusa 410-281-1130 jgennus1@jhmi.edu

Locations
Layout table for location information
United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Gail Daumit Johns Hopkins University

Publications:
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03999892     History of Changes
Other Study ID Numbers: IRB00194122
P50MH115842 ( U.S. NIH Grant/Contract )
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders