Healthy ReStart Intervention to Improve Health and Functioning
ConditionMental Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Illinois at Chicago
About this trial
This study tests an intervention that uses health coaching, motivational interviewing, positive psychology, and online wellness tools to help adults with mental illness return to active lives after major disruptions such as the COVID-19 pandemic.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 and older
Diagnosis of serious mental illness defined as a DSM 5 psychiatric disorder and moderate to severe functional impairment
Membership in a collaborating community mental health agency
Access to the Internet for online meetings
Disqualifiers
A cognitive impairment preventing informed consent
Unable to communicate in English
Trial design
Design model
Parallel
Treatments tested in this trial
Healthy ReStart
BehavioralIn addition to receiving mental health services as usual, subjects receive services from health coaches over a four-month period to assist them in creating a Restart plan and attaining related life goals.
Services as Usual
Other interventionSubjects receive mental health services as usual.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: Services as UsualActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Perceived Competence
Change in participants' feelings of competence about their ability to improve their lives and follow through on their life goals as measured by the Perceived Competence scale. This 4-item scale using a 7-point Likert response format ranging from "not at all true" to "very true." The minimum value is 4 and the maximum is 28, with higher scores indicating a better outcome.
Time frame
Study entry (pre-intervention), 6 months post-study entry2
Change in Depressive Symptoms
Change in symptoms of depression and anhedonia is measured by the Patient Health Questionniare-9. Total score ranges from 0 to 27 with higher values indicating greater likelihood of depressive disorder. Total score is calculated by adding the 9 item scores.
Time frame
Study entry (pre-intervention), 6 months post-study entry3
Change in Anxiety Symptoms
Change in anxiety symptoms is measured by The Generalized Anxiety Disorder 7-item Questionnaire. Total score ranges from 0 to 21 with higher values indicating greater likelihood of generalized anxiety disorder. Total score is calculated by adding the 7 item scores.
Time frame
Study entry (pre-intervention), 6 months post-study entry4
Change in Coping Mastery
Change in subjects' sense of personal control over important life outcomes is measured by the Coping Mastery Scale. Higher values equal better coping mastery. Minimum=2 and maximum=49.
Time frame
Study entry (pre-intervention), 6 months post-study entrySecondary outcomes
1
Change in Physical and Mental Functioning
Change in physical and mental functioning is measured by the Veterans Rand 12. This measure assesses physical functioning, role limitations due to physical or mental health problems, pain, energy, mental and physical health, and social functioning. Responses to each item create physical component and mental component summary scores. The item weights account for differences in the strength of relationships between individual items and the physical and mental component scores. Scores are standardized using a T-score metric, with a mean of 50 and a standard deviation of 10.
Time frame
Study entry (pre-intervention), 6 months post-study entry2
Change in Ability to Self-Advocate
Change in the ability to advocate for oneself with behavioral health care providers is assessed by the Patient Self-Advocacy Scale, an 18-item scale with a 5-point Likert response set ranging from "strongly disagree" to "strongly agree." Dimensions include in patient knowledge, assertiveness, and potential for mindful non-adherence to treatment. Scoring involves computing the mean scale score, so therefore values range from a minimum of 1 to a maximum of 5, with higher scores indicating a better outcome.
Time frame
Study entry (pre-intervention), 6 months post-study entrySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Illinois at Chicago
Lead sponsor
National Institute on Disability, Independent Living, and Rehabilitation Research
Collaborator
Source ClinicalTrials.gov