Learn to Quit App for Manic Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Duke University, Durham, NC
Manic Disorder+8 More
Learn to Quit App - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a smoking cessation app is effective for people with serious mental illness.

See full description

Eligible Conditions

  • Manic Disorder
  • Tobacco Dependence
  • Schizophrenia
  • Depression
  • Schizoaffective Disorders
  • Mental Illnesses

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Learn to Quit App will improve 1 primary outcome, 7 secondary outcomes, and 8 other outcomes in patients with Manic Disorder. Measurement will happen over the course of Weeks 0-24.

1 month follow-up
30-day point prevalence abstinence rates
Average app usability scores
3 month follow-up
Nicotine gum use
Nicotine patch use
6 month follow-up
Average acceptance of physical smoking cravings
Average number of quit attempts per group
Average user experience scores
Biochemically confirmed 30-day point prevalence abstinence rates
CO-verified 7-day point-prevalence abstinence at 6-month follow-up
Change in average number of cigarettes smoked per day
Continuous abstinence rates
Prolonged abstinence rates
Time to 7-day relapse
Weeks 0-24
Average duration of app use
Average frequency of app use
Average number of app modules completed

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Learn to Quit
1 of 1
Experimental Treatment

This trial requires 450 total participants across 1 different treatment group

This trial involves a single treatment. Learn To Quit App is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Learn to QuitA smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 5-10 week course of NRT gum. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Learn to Quit App
2017
Completed Phase 1
~70
Smartphone coaching
2021
N/A
~60
Nicotine
FDA approved
Nicotine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 month follow-up
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 month follow-up for reporting.

Closest Location

Duke University - Durham, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The desire to quit smoking is indicated by the serious intention to quit tobacco within the next 6 months. show original
is a significant predictor of employment status Having a score of two or greater on the WHODAS 8 item version is a significant predictor of employment status. show original
Smoker is defined as someone who smokes at least five cigarettes per day over the past six months. show original
Willing and medically eligible to use NRT;
The subject is currently receiving psychiatric treatment and plans to continue receiving treatment for the duration of the study. show original
Age 18 and older;
The DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar, or recurring major depressive disorder can be incredibly disabling and can significantly impact a person's quality of life. show original

Patient Q&A Section

How many people get schizoaffective disorders a year in the United States?

"People with schizoaffective disorders accounted for 3.2% of the whole US population sampled and comprised 1% of those with a prior diagnosis of any mood or anxiety disorder." - Anonymous Online Contributor

Unverified Answer

What causes schizoaffective disorders?

"It is not known what predisposes to development of schizoaffective disorders. If we knew this, it might contribute toward providing new treatments and better understanding of schizoaffective disorder." - Anonymous Online Contributor

Unverified Answer

What is schizoaffective disorders?

"Schizoaffective disorder is a psychiatric disorder that involves experiences of mood swings between mania and depression that is often characterized by mood symptoms that resemble a mood disorder. It is distinguished from bipolar disorder by the absence of manic episodes.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for schizoaffective disorders?

"At the time of the study, no consensus existed regarding optimal treatment for SPD. This review summarizes the treatments currently used to treat SPD, and provides a rating of the treatments' evidence base." - Anonymous Online Contributor

Unverified Answer

Can schizoaffective disorders be cured?

"Schizoaffective disorders have a very high risk of recurrence. Patients treated with cognitive behavioral therapy are at statistically significantly lower risk to relapse than patients treated with antidepressant agents alone, irrespective of the type of antidepressant medication (tricyclic or fluoxetine. However, these results will have to be confirmed in a randomized controlled trial." - Anonymous Online Contributor

Unverified Answer

What are the signs of schizoaffective disorders?

"Schizoaffective disorders can have a variety of physical signs and symptoms. Many of these symptoms appear with acute mania and may disappear with hypomania, however the most common physical signs are swelling of the face or an abnormal lump on the back of your neck. Treatment of schizoaffective disorder can be complicated, and may require hospitalisation or admission. There are many other types of bipolar disorders, the symptoms and treatment of which are not discussed here.\n" - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving learn to quit app?

"As of August 31, 2013, no clinical trial of either V-CAT or Learn to Quit has been accepted for publication (see http://clinicaltrials.gov/ct2/show/NCT00262736) reflecting the preliminary findings of a recent clinical study." - Anonymous Online Contributor

Unverified Answer

What is learn to quit app?

"This app's primary aim is to provide evidence-based support for quitting smoking by informing people and helping them to control their use of smoking. However, in its use in the clinic, the app showed potential to support other treatment and recovery goals, such as the following:\n- fostering positive and productive interactions between clinicians and patients\n- empowering clients to be more actively involved in their health by sharing coping skills and relapse prevention strategies with other patients\n- reinforcing client autonomy by reducing the sense of being coerced by the clinician\n- enabling clients to work toward their individual treatment objectives as part of a comprehensive recovery program." - Anonymous Online Contributor

Unverified Answer

Does learn to quit app improve quality of life for those with schizoaffective disorders?

"This small study shows the potential for learning to quit to not only improve adherence to anticholinergic medication but to also improve quality of life. Further research is needed to clarify this relationship. Clinicians should routinely work with patients with psychosis to teach skills to quit." - Anonymous Online Contributor

Unverified Answer

How serious can schizoaffective disorders be?

"The presence of psychotic symptoms and a history of depressive episodes are the strongest predictors of suicide in patients with schizophrenia. The presence of symptoms suggestive for psychotic disorder, such as hallucinations or delusions, is a strong predictor of suicidal behavior and death." - Anonymous Online Contributor

Unverified Answer

What does learn to quit app usually treat?

"Results from a recent clinical trial found that learning to quit app may not be a valid option for treatment of current smokers in clinical practice. In this sample, those who learned to quit app reported less improvement in symptoms and less satisfaction than did those who did not learn to quit app. Asking about learning to quit app is a valid question in the clinical setting, but this approach should not be used as an adjunct to formal treatments for smoking cessation alone." - Anonymous Online Contributor

Unverified Answer

What is the latest research for schizoaffective disorders?

"Schizoaffective disorder is a disabling illness that poses special challenges for family, peers, and society. Although it is likely that no single explanatory model, such as biopsychosocial, will be adequate to describe a spectrum of clinical and biological variation among individuals with schizoaffective disorders, our findings from research to date reinforce the relevance of using the DSM-IV categorical approach." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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