NCT02558075

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable depression

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

September 21, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
2.4 years until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 27, 2022

Status Verified

December 1, 2022

Enrollment Period

3.6 years

First QC Date

September 21, 2015

Last Update Submit

December 22, 2022

Conditions

DepressionAnxietyBipolar Disorder

Outcome Measures

Primary Outcomes (4)

  • Satisfaction with Life Scale

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

    15 weeks post baseline assessment

  • Patient Health Questionnaire

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

    15 weeks post baseline assessment

  • Generalized Anxiety Disorder scale

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

    15 weeks post baseline assessment

  • 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).

    15 weeks post baseline assessment

Study Arms (1)

MoodLifters Program

EXPERIMENTAL

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

Behavioral: MoodLifters Sessions

Interventions

MoodLifters SessionsBEHAVIORAL

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.

MoodLifters Program

Eligibility Criteria

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48103, United States

Location

Related Publications (3)

  • 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.

    PMID: 26322706BACKGROUND

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

    PMID: 6399757BACKGROUND

  • 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.

    PMID: 22130747BACKGROUND

MeSH Terms

Conditions

DepressionAnxiety DisordersBipolar Disorder

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersBipolar and Related DisordersMood Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Psychology, Associate Director of the University of Michigan Depression Center

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 23, 2015

Study Start

February 1, 2018

Primary Completion

September 1, 2021

Study Completion

December 1, 2022

Last Updated

December 27, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)