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DepressionNCT02558075

Mood Lifters: A Self Help Program

A study testing MoodLifters Sessions in people with Depression and Anxiety, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Depression, Anxiety, Bipolar Disorder
What is being tested?
MoodLifters Sessions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
1 Feb 2018to 1 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Michigan

    Ann Arbor, Michigan, 48103

Other trials in United States

About this study

Official title: Mood Lifters: A Self Help Program to Improve One's Psychological and Behavioral Well Being

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.

Read the 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.

Being tested
MoodLifters Sessions
Medical subject headings
Depression, Anxiety Disorders, Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MoodLifters SessionsBehavioural

    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.

Study groups in NCT02558075
Study groupRoleWhat they receive
MoodLifters ProgramExperimentalA program to provide evidence-based education and skills to reduce psychological distress and enrich people's lives.
Receives: Behavioral: MoodLifters Sessions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Satisfaction with Life Scale

    Change in overall satisfaction with life will be measured from baseline to 15 weeks.

    Measured: 15 weeks post baseline assessment

  2. Patient Health Questionnaire

    Change in depression symptomology will be measured from baseline to 15 weeks.

    Measured: 15 weeks post baseline assessment

  3. Generalized Anxiety Disorder scale

    Change in anxiety symptomology will be measured from baseline to 15 weeks.

    Measured: 15 weeks post baseline assessment

  4. 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).

    Measured: 15 weeks post baseline assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2015 (estimated)
  2. Study start1 Feb 2018
  3. Primary completion1 Sep 2021
  4. Study completion1 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02558075
Sponsor's protocol ID
HUM00097120
Status last verified
Dec 2022
First submitted
21 Sep 2015
Last updated
27 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26322706
  • Hattie JA, Sharpley CF, Rogers HJ. Comparative effectiveness of professional and paraprofessional helpers. Psychol Bull. 1984 May;95(3):534-41. No abstract available.

    PubMed 6399757
  • 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.

    PubMed 22130747

Questions about this trial

What is this clinical trial studying?

A study testing MoodLifters Sessions in people with Depression and Anxiety, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Satisfaction with Life Scale (time frame: 15 weeks post baseline assessment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02558075, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2022.

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Mood Lifters: A Self Help Program (NCT02558075) | AzTrials