NCT03308162

Brief Summary

This study is testing the acceptability and feasibility of an active, experiential group therapy for health behavior change within a medical setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

October 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

10 months

First QC Date

October 3, 2017

Last Update Submit

September 25, 2018

Conditions

Keywords

Integrated Behavioral Health Care

Outcome Measures

Primary Outcomes (2)

  • Acceptability and feasibility

    Survey measure of acceptability and feasibility of the novel study in a health care setting

    5 weeks

  • Change in acceptability and feasibility from 5 weeks

    Survey measure of a change in acceptability and feasibility of the novel study in a health care setting

    13 weeks

Secondary Outcomes (28)

  • Personal Medical History Questionnaire

    Baseline

  • Health Specific Self Efficacy Scales

    Baseline

  • Change in health specific self efficacy from baseline

    5-weeks

  • Change in health specific self efficacy from 5-weeks

    13-weeks

  • Exercise Beliefs and Benefits Scale (EBBS)

    Baseline, 5-, and 13-weeks

  • +23 more secondary outcomes

Study Arms (1)

Group Intervention

EXPERIMENTAL

Cognitive behavioral experiential group therapy for health behavior change

Behavioral: Cognitive behavioral experiential group therapy

Interventions

The Kickstart Health Program is a Cognitive-Behavioral Experiential Therapy (CBET) that is administered via a person-centered group therapy format. Participants receive multiple therapeutic components that include psychoeducation, cognitive behavioral therapy, motivational interviewing, mindfulness, and acceptance and commitment therapy. Participants will also meditate and exercise in the group.

Also known as: Kickstart Health
Group Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A patient of the Beaumont Family Medicine Center - Troy/Sterling Heights
  • Access to a computer or electronic device with an internet browser
  • Internet connectivity
  • Patient verbally confirms during recruitment phone call that they can independently or with minimal assistance complete online surveys
  • English speaking

You may not qualify if:

  • Individuals who do not have regular access to internet connectivity
  • Not approved by their physician to complete the group exercises
  • Denies the ability to fill out online surveys with minimal assistance
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beaumont Family Medicine

Sterling Heights, Michigan, 48314, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Lori Lackman-Zeman, PhD

    Corewell Health East

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Within subjects repeated measures
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 3, 2017

First Posted

October 12, 2017

Study Start

October 10, 2017

Primary Completion

July 31, 2018

Study Completion

August 31, 2018

Last Updated

September 26, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations