DepressionNCT05078450
Mood Lifters Online for Graduate Students and Young Professionals
A study testing Mood Lifters in people with Depression and Anxiety Disorders, run by University of Michigan at 1 site in United States.
Trial summary
Mood Lifters is a revolutionary mental wellness program that teaches scientifically validated strategies in a supportive group setting. This study will test two new versions of the program designed specifically for graduate students and young professionals. Read more about this study
- Who is it for?
- Ages 22 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety Disorders, Mood Disorders
- What is being tested?
- Mood Lifters
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2021to 1 Feb 2023
- 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 22 to 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants ages 22-32 (must identify as either a graduate student or a young professional)
Who cannot join
- Active suicidality, mania, or psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mood Lifters Online
Mood Lifters is a revolutionary mental wellness program that teaches scientifically validated strategies in a supportive group setting. This study will test two new versions of the program designed specifically for graduate students and young professionals.
Participants will need to attend 12 hour long virtual weekly meetings on Zoom that focus on helpful mental health strategies and skills. Participants will be encourage to practice what the participants learn at home in order to improve their mood or mental wellness. Additionally, participants will complete a series of measures (approx. 1-1.5 hours) prior to, at the end of the program, 1 month after the program and 6 months after the program.
- Conditions
- Depression, Anxiety Disorders, Mood Disorders, Mental Illness, Stress
- Being tested
- Mood Lifters
- Medical subject headings
- Depression, Anxiety Disorders, Mood Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mood LiftersBehavioural
Participants will need to attend 12 hour long virtual weekly meetings on Zoom that focus on helpful mental health strategies and skills. Participants will be encourage to practice what they learn at home in order to improve their mood or mental wellness.
| Study group | Role | What they receive |
|---|---|---|
| Graduate Student Program | Experimental | This is the graduate student version of the program. The original program has been tailored to this population to meet its specific needs and address its specific concerns. Receives: Behavioral: Mood Lifters |
| Young Professional Program | Experimental | This is the young professional version of the program. The original program has been tailored to this population to meet its specific needs and address its specific concerns. Receives: Behavioral: Mood Lifters |
| Waitlist | No intervention | This is the waitlist. Participants may be randomly assigned here first. After the typical period fo the intervention on the waitlist (12 weeks), these participants will be invited to join the arm which they are most appropriate for (i.e., graduate student or young professional). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire - 9
Assesses Depressive Symptoms (Range 0-27; higher scores indicate more significant symptoms of depression)
Measured: through study completion, an average of 1 year
Generalized Anxiety Disorder - 7
Assesses Anxiety Symptoms (Range 0-21; higher scores indicate more significant symptoms of anxiety)
Measured: through study completion, an average of 1 year
Perceived Stress Scale
Assesses Perceived stress (Range 0-40; higher scores indicate more significant perceived stress)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start22 Sep 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Deldin, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078450
- Sponsor's protocol ID
- HUM00163570
- Status last verified
- Dec 2024
- First submitted
- 22 Sep 2021
- Last updated
- 6 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garg T, Votta CM, Prakash N, Deldin PJ. An investigation into the effectiveness of Mood Lifters in the context of trauma exposure. Psychol Serv. 2024 Aug;21(3):518-528. doi: 10.1037/ser0000789. Epub 2023 Aug 24.
PubMed 37616078Pokowitz EL, Prakash N, Planaj D, Oprandi S, Deldin PJ. Mood Lifters for Graduate Students and Young Adults: A Mixed-Methods Investigation into Mechanisms of Change in Online Group Therapy. Behav Sci (Basel). 2024 Mar 20;14(3):252. doi: 10.3390/bs14030252.
PubMed 38540555Prakash N, Votta CM, Deldin PJ. Treatment for graduate students: Blunting the emotional toll of postgraduate education. J Consult Clin Psychol. 2023 Dec;91(12):708-716. doi: 10.1037/ccp0000844. Epub 2023 Sep 21.
PubMed 37732972
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mood Lifters Online
- ClinicalTrials.gov ID
- NCT05078450
- Acronym / sponsor ID
- HUM00163570
- Conditions
- Depression, Anxiety Disorders, Mood Disorders, Mental Illness, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mood Lifters is a revolutionary mental wellness program that teaches scientifically validated strategies in a supportive group setting. This study will test two new versions of the program designed specifically for graduate students and young professionals.
Participants will need to attend 12 hour long virtual weekly meetings on Zoom that focus on helpful mental health strategies and skills. Participants will be encourage to practice what the participants learn at home in order to improve their mood or mental wellness. Additionally, participants will complete a series of measures (approx. 1-1.5 hours) prior to, at the end of the program, 1 month after the program and 6 months after the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Graduate Student Program | Experimental | Behavioral: Mood LiftersThis is the graduate student version of the program. The original program has been tailored to this population to meet its specific needs and address its specific concerns. |
| Young Professional Program | Experimental | Behavioral: Mood LiftersThis is the young professional version of the program. The original program has been tailored to this population to meet its specific needs and address its specific concerns. |
| Waitlist | No intervention | –This is the waitlist. Participants may be randomly assigned here first. After the typical period fo the intervention on the waitlist (12 weeks), these participants will be invited to join the arm which they are most appropriate for (i.e., graduate student or young professional). |
Who may qualify
- Ages
- 22 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants ages 22-32 (must identify as either a graduate student or a young professional)
Key exclusion criteria (1 listed)
- Active suicidality, mania, or psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mood LiftersParticipants will need to attend 12 hour long virtual weekly meetings on Zoom that focus on helpful mental health strategies and skills. Participants will be encourage to practice what they learn at home in order to improve their mood or mental wellness. | Behavioural | Graduate Student Program, Young Professional Program |
Primary outcome
Patient Health Questionnaire - 9
Time frame: through study completion, an average of 1 year
Assesses Depressive Symptoms (Range 0-27; higher scores indicate more significant symptoms of depression)
Generalized Anxiety Disorder - 7
Time frame: through study completion, an average of 1 year
Assesses Anxiety Symptoms (Range 0-21; higher scores indicate more significant symptoms of anxiety)
Perceived Stress Scale
Time frame: through study completion, an average of 1 year
Assesses Perceived stress (Range 0-40; higher scores indicate more significant perceived stress)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Results publication: PubMed 37616078Garg T, Votta CM, Prakash N, Deldin PJ. An investigation into the effectiveness of Mood Lifters in the context of trauma exposure. Psychol Serv. 2024 Aug;21(3):518-528. doi: 10.1037/ser0000789. Epub 2023 Aug 24.
- Results publication: PubMed 38540555Pokowitz EL, Prakash N, Planaj D, Oprandi S, Deldin PJ. Mood Lifters for Graduate Students and Young Adults: A Mixed-Methods Investigation into Mechanisms of Change in Online Group Therapy. Behav Sci (Basel). 2024 Mar 20;14(3):252. doi: 10.3390/bs14030252.
- Results publication: PubMed 37732972Prakash N, Votta CM, Deldin PJ. Treatment for graduate students: Blunting the emotional toll of postgraduate education. J Consult Clin Psychol. 2023 Dec;91(12):708-716. doi: 10.1037/ccp0000844. Epub 2023 Sep 21.
- Individual participant dataSharing planned: No
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mood Lifters in people with Depression and Anxiety Disorders, 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 1 inclusion and 1 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 6 Dec 2024. 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?
Patient Health Questionnaire - 9 (time frame: through study completion, an average of 1 year). The study lists 3 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 NCT05078450, 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 6 Dec 2024.