search
Back to results

Mood Lifters: A Self Help Program

Primary Purpose

Depression, Anxiety, Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MoodLifters Sessions
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Exclusion Criteria:

  • active suicidal thoughts or behavior
  • active psychosis
  • active mania.

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MoodLifters Program

Arm Description

A program to provide evidence-based education and skills to reduce psychological distress and enrich people's lives.

Outcomes

Primary Outcome Measures

Satisfaction with Life Scale
Change in overall satisfaction with life will be measured from baseline to 15 weeks.
Patient Health Questionnaire
Change in depression symptomology will be measured from baseline to 15 weeks.
Generalized Anxiety Disorder scale
Change in anxiety symptomology will be measured from baseline to 15 weeks.
Emotion visual analog scale
change in emotion ratings (e.g. happy, sad, angry) will be measured on a visual analog scale ranging from not at all (happy, sad, angry) to extremely (happy, sad, angry).

Secondary Outcome Measures

Full Information

First Posted
September 21, 2015
Last Updated
December 22, 2022
Sponsor
University of Michigan
search

1. Study Identification

Unique Protocol Identification Number
NCT02558075
Brief Title
Mood Lifters: A Self Help Program
Official Title
Mood Lifters: A Self Help Program to Improve One's Psychological and Behavioral Well Being
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Large scale, effective, low-cost, and evidence-based programs that can nimbly translate new research discoveries into prevention and care for psychosocial based problems are urgently needed. This study hopes to provide support for Mood-Lifters, a template for a low-cost evidence based program, so that investigators may fill this gap and relieve suffering for millions of people who are not getting adequate mental health care. Mood-Lifters provides a low cost, research based program designed to enrich people's lives and reduce psychological distress. It is designed to provide useful support, coaching and information. It seeks to help people enhance pleasure, engagement and meaning in their lives while minimizing depression, fear, loneliness and other negative feelings via a proprietary peer based program that offers weekly meetings and other flexible support options. The goal of this pilot study is to test the efficacy of this program. This is not traditional therapy, rather an educational supportive program similar to WeightWatchers, but for mental health.
Detailed Description
Approximately half the population of the United States will meet criteria for a diagnosable mental illness over their lifetime. Many of these individuals will experience changes in productivity, family relationships and self-esteem. Some will engage in behaviors that endanger themselves or others. A small percentage of these people will receive treatment. This lack of treatment is partly due to stigma or lack of knowledge, but it is also due to lack of affordable or available services. Furthermore, even when people manage to receive care, it is often ineffective because it is not evidence-based. This lack of prevention and treatment is costly. The economic burden of depression alone is second only to cardiovascular disease, and anxiety disorders cost the U.S. more than $42 billion per year. Moreover, it has been estimated that as many as 70% of primary care visits stem from psychosocial issues. This is problematic because primary care physicians often have neither the time nor expertise to provide adequate support for the wide range of psychosocial issues with which their patients are coping. In short, a large scale, effective, low-cost, evidence-based program that can nimbly translate new research discoveries into prevention and care for psychosocial based problems is urgently needed. Mood Lifters intends to be the "Weight-watchers" of mental health and is a program designed to precisely fill these gaps and relieve these burdens for millions of people who are not getting adequate mental health care. Weight watchers is a highly effective, evidence based, para-professionally delivered program that serves nearly 1.2 million customers a week. It serves a different population than a primary care physician or an obesity specialist. It is not bariatric surgery but rather supports the majority of people who need to lose weight. In comparison, Mood Lifters is not intensive psychiatric care. Rather, it serves an adjunctive service to primary care doctor's typical medical care (i.e., Medications) and utilizes a de-stigmatized service delivery model. This study will pilot this innovative program. Researchers will test and refine the proof of concept in multiple community groups from Ann Arbor. Each group will consist of 8-12 participants who will be recruited from local communities via a variety of methods. Criteria for participation will be all adults who are not actively manic, suicidal or psychotic. These participants will not be able to participate and will be referred to mental health professionals. This program consists of 15 different sessions with a different topic for each session. These sessions will occur once a week for 15 weeks and will last approximately an hour each. Prior to participation in the first session, participants will complete comprehensive baseline measures, including a comprehensive mood assessment and measures to assess their knowledge, attitudes, and behaviors relating to the topics to be covered. This will take approximately 2 hours. At each meeting, participants will complete a brief questionnaire on all the topics in order to track progress from week to week. Between weekly meetings, participants will practice and track their skill-building via a Daily & Weekly Points Checklist, which will include the topics discussed over the course of the program. During the first group session, the group facilitator will provide an overview of the program, including the weekly topics. These topics will be in one of five theoretically important areas: biological, cognitive, affective, behavioral and social. Each subsequent week will involve an in-depth exploration of each topic, including why it is important to mental well-being and practical ideas about how to implement positive changes into one's everyday life. Following the facilitator's brief presentation, group members will be invited to share their experiences, challenges, and provide peer support. At the conclusion of the program, each participant will again complete the comprehensive mood assessment as well as the same measures of knowledge, attitudes, and behaviors that were assessed at the beginning of the 15-week period. Additionally, participants will have the opportunity to complete these same measures at 1 month and 6 month post Mood Lifters program. A final analysis will then be conducted to assess the program's overall efficacy and its efficacy among the various populations described above. The results will be formally written up and reported, program modifications will be made, and further grant funding will be pursued.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Bipolar Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MoodLifters Program
Arm Type
Experimental
Arm Description
A program to provide evidence-based education and skills to reduce psychological distress and enrich people's lives.
Intervention Type
Behavioral
Intervention Name(s)
MoodLifters Sessions
Intervention Description
This program consists of 15 different sessions with a different topic for each session. These sessions will occur once a week for 15 weeks and will last approximately an hour each. These topics will be in one of five theoretically important areas: biological, cognitive, affective, behavioral and social. Each subsequent week will involve an in-depth exploration of each topic, including why it is important to mental well-being and practical ideas about how to implement positive changes into one's everyday life. Following the facilitator's brief presentation, group members will be invited to share their experiences, challenges, and provide peer support.
Primary Outcome Measure Information:
Title
Satisfaction with Life Scale
Description
Change in overall satisfaction with life will be measured from baseline to 15 weeks.
Time Frame
15 weeks post baseline assessment
Title
Patient Health Questionnaire
Description
Change in depression symptomology will be measured from baseline to 15 weeks.
Time Frame
15 weeks post baseline assessment
Title
Generalized Anxiety Disorder scale
Description
Change in anxiety symptomology will be measured from baseline to 15 weeks.
Time Frame
15 weeks post baseline assessment
Title
Emotion visual analog scale
Description
change in emotion ratings (e.g. happy, sad, angry) will be measured on a visual analog scale ranging from not at all (happy, sad, angry) to extremely (happy, sad, angry).
Time Frame
15 weeks post baseline assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Exclusion Criteria: active suicidal thoughts or behavior active psychosis active mania.
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26322706
Citation
Gudzune KA, Bleich SN, Clark JM. Efficacy of Commercial Weight-Loss Programs. Ann Intern Med. 2015 Sep 1;163(5):399. doi: 10.7326/L15-5130-3. No abstract available.
Results Reference
background
PubMed Identifier
6399757
Citation
Hattie JA, Sharpley CF, Rogers HJ. Comparative effectiveness of professional and paraprofessional helpers. Psychol Bull. 1984 May;95(3):534-41. No abstract available.
Results Reference
background
PubMed Identifier
22130747
Citation
Patel V, Weiss HA, Chowdhary N, Naik S, Pednekar S, Chatterjee S, Bhat B, Araya R, King M, Simon G, Verdeli H, Kirkwood BR. Lay health worker led intervention for depressive and anxiety disorders in India: impact on clinical and disability outcomes over 12 months. Br J Psychiatry. 2011 Dec;199(6):459-66. doi: 10.1192/bjp.bp.111.092155. Erratum In: Br J Psychiatry. 2012 Feb;200(2):166.
Results Reference
background

Learn more about this trial

Mood Lifters: A Self Help Program

We'll reach out to this number within 24 hrs