CLINICAL TRIAL

MBCT Intervention for Psychosis, Involutional

1 Prior Treatment
Relapsed
Waitlist Available · 18+ · All Sexes · Clemson, SC

Virtual Mindfulness Training for Adults With History of Depression

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About the trial for Psychosis, Involutional

Eligible Conditions
Depressive Disorder, Major · Depression · Major Depressive Disorder (MDD) · Depressive Disorder

Treatment Groups

This trial involves 2 different treatments. MBCT Intervention 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
MBCT Intervention
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Psychosis, Involutional or one of the other 3 conditions listed above. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You are over 18 years of age. show original
be a resident of upstate South Carolina or Prisma Health beneficiary
have a SCID confirmed diagnosis of a prior MDD episode
be willing to share contact information
have English literacy 6th grade or above
be able to attend intervention sessions.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Changes between pre-intervention (baseline), 8 weeks (post-intervention for experimental group), and 16 weeks (post-intervention for control group and follow-up for experimental group) will be assessed.
Screening: ~3 weeks
Treatment: Varies
Reporting: Changes between pre-intervention (baseline), 8 weeks (post-intervention for experimental group), and 16 weeks (post-intervention for control group and follow-up for experimental group) will be assessed.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Changes between pre-intervention (baseline), 8 weeks (post-intervention for experimental group), and 16 weeks (post-intervention for control group and follow-up for experimental group) will be assessed..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether MBCT Intervention will improve 2 primary outcomes, 7 secondary outcomes, and 3 other outcomes in patients with Psychosis, Involutional. Measurement will happen over the course of Intervention fidelity will be assessed over the course of 8 weeks for each intervention group cohort..

Intervention fidelity
INTERVENTION FIDELITY WILL BE ASSESSED OVER THE COURSE OF 8 WEEKS FOR EACH INTERVENTION GROUP COHORT.
Intervention fidelity will be assessed with the Mindfulness-Based Relapse Prevention Adherence and Competence Scale (MBRP-AC; Chawla et al., 2010). All sessions will be audio recorded. Two members of the research team will rate 50% of a random selection of sessions using the MBRP-AC. Raters will code at least 10 practice sessions, which will be reviewed with the research team until acceptable reliability is achieved, and they will attend regular recalibration meetings to prevent drift. Group facilitators will also meet weekly with the licensed clinical psychologist, a member of the research team, for supervision.
INTERVENTION FIDELITY WILL BE ASSESSED OVER THE COURSE OF 8 WEEKS FOR EACH INTERVENTION GROUP COHORT.
Savoring
CHANGES BETWEEN PRE-INTERVENTION (BASELINE), 8 WEEKS (POST-INTERVENTION FOR EXPERIMENTAL GROUP), AND 16 WEEKS (POST-INTERVENTION FOR CONTROL GROUP AND FOLLOW-UP FOR EXPERIMENTAL GROUP) WILL BE ASSESSED.
The Savoring Beliefs Inventory (Bryant, 2003) is a 24-item questionnaire consisting of three subscales: anticipating, savoring the moment, and reminiscing. Half of the items are positively formulated, while the other half are negatively framed. Each item is rated on a 7-point Likert scale ranging from "strongly disagree" to "strongly agree."
CHANGES BETWEEN PRE-INTERVENTION (BASELINE), 8 WEEKS (POST-INTERVENTION FOR EXPERIMENTAL GROUP), AND 16 WEEKS (POST-INTERVENTION FOR CONTROL GROUP AND FOLLOW-UP FOR EXPERIMENTAL GROUP) WILL BE ASSESSED.
Adherence to MAT
CHANGES BETWEEN PRE-INTERVENTION (BASELINE), 8 WEEKS (POST-INTERVENTION FOR EXPERIMENTAL GROUP), AND 16 WEEKS (POST-INTERVENTION FOR CONTROL GROUP AND FOLLOW-UP FOR EXPERIMENTAL GROUP) WILL BE ASSESSED.
Adherence to other medical treatments not given as part of this study will be assessed with the Adherence to Refills and Medications Scale (ARMS; Kripalani et al., 2009). The ARMS scale is a 12 item scale that measures adherence to medications.
CHANGES BETWEEN PRE-INTERVENTION (BASELINE), 8 WEEKS (POST-INTERVENTION FOR EXPERIMENTAL GROUP), AND 16 WEEKS (POST-INTERVENTION FOR CONTROL GROUP AND FOLLOW-UP FOR EXPERIMENTAL GROUP) WILL BE ASSESSED.
Perceived Quality of Life (health, well-being)
CHANGES BETWEEN PRE-INTERVENTION (BASELINE), 8 WEEKS (POST-INTERVENTION FOR EXPERIMENTAL GROUP), AND 16 WEEKS (POST-INTERVENTION FOR CONTROL GROUP AND FOLLOW-UP FOR EXPERIMENTAL GROUP) WILL BE ASSESSED.
Quality of life will be assessed with the World Health Organization Quality of Life (WHOQOL-BREF; World Health Organization, 2004). The 26-item scale assesses quality of life, health, and other areas of wellbeing. Items are measured on a five-point scale.
CHANGES BETWEEN PRE-INTERVENTION (BASELINE), 8 WEEKS (POST-INTERVENTION FOR EXPERIMENTAL GROUP), AND 16 WEEKS (POST-INTERVENTION FOR CONTROL GROUP AND FOLLOW-UP FOR EXPERIMENTAL GROUP) WILL BE ASSESSED.
Emotion regulation
CHANGES BETWEEN PRE-INTERVENTION (BASELINE), 8 WEEKS (POST-INTERVENTION FOR EXPERIMENTAL GROUP), AND 16 WEEKS (POST-INTERVENTION FOR CONTROL GROUP AND FOLLOW-UP FOR EXPERIMENTAL GROUP) WILL BE ASSESSED.
Emotion regulation will be assessed with the Difficulties in Emotion Regulation Scale-Short Form (Kaufman et al., 2016), an 18-item measure used to identify emotional regulation issues in adults. Higher values reflect greater difficulty with emotion regulation
CHANGES BETWEEN PRE-INTERVENTION (BASELINE), 8 WEEKS (POST-INTERVENTION FOR EXPERIMENTAL GROUP), AND 16 WEEKS (POST-INTERVENTION FOR CONTROL GROUP AND FOLLOW-UP FOR EXPERIMENTAL GROUP) WILL BE ASSESSED.
Frequency of major depressive disorder relapse episodes
CHANGES BETWEEN PRE-INTERVENTION (BASELINE), 8 WEEKS (POST-INTERVENTION FOR EXPERIMENTAL GROUP), AND 16 WEEKS (POST-INTERVENTION FOR CONTROL GROUP AND FOLLOW-UP FOR EXPERIMENTAL GROUP) WILL BE ASSESSED.
Major depressive relapse episodes will be identified using the ICD-10 codes for MDD in the DSM-5 (First, 2014).
CHANGES BETWEEN PRE-INTERVENTION (BASELINE), 8 WEEKS (POST-INTERVENTION FOR EXPERIMENTAL GROUP), AND 16 WEEKS (POST-INTERVENTION FOR CONTROL GROUP AND FOLLOW-UP FOR EXPERIMENTAL GROUP) WILL BE ASSESSED.
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Who is running the study

Principal Investigator
H. Z.
Prof. Heidi Zinzow, Professor
Clemson University

Patient Q & A Section

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

What causes psychosis, involutional?

The present study suggests the presence of psychosis and/or major depressive disorder and/or panic disorder and/or phobic syndromes to be a frequent coexistence in elderly patients in which schizophrenia or Alzheimer's diseases are not suspected.

Anonymous Patient Answer

What are the signs of psychosis, involutional?

Findings from a recent study was conducted to identify specific features of psychosis. Findings from a recent study suggest that the signs of the syndrome include the following: (1) a decline in intellectual, emotional and social functioning; (2) psychotic features including delusions, hallucinations, disorganized thinking, inappropriate social conduct and bizarre behaviors; and (3) a decrease in motivation.

Anonymous Patient Answer

How many people get psychosis, involutional a year in the United States?

It is unknown whether mental disorders are becoming more common as people age. But they are less common than in the past. It is still likely that the most severe mental problems will become more common in the future. If this is less severe, as has occurred in the past, more people will be in need of help in the short term but may benefit in the longer term.

Anonymous Patient Answer

Can psychosis, involutional be cured?

In a recent study, findings of this study showed that most of the patients who had an active psychotic illness and had a normal level of serum cortisol at follow-up were not at risk of developing an overt psychosis during the course of the study. One of our cases, who had a severe depressive episode following a manic episode, had a long-term follow-up. She was the only case to have a manic episode in the study, and she had a long time to respond to treatment. Her symptoms did not regress and she still suffered from depression and anosognosia.

Anonymous Patient Answer

What are common treatments for psychosis, involutional?

The data of this study suggest that antidepressants and cognitive behaviour therapy are the most frequently used treatments of psychosis during primary or secondary remission of nonaffective and affective psychosis. Antipsychotic medications are commonly used in the treatment of psychosis and are particularly effective in the treatment of schizophrenic relapse.

Anonymous Patient Answer

What is psychosis, involutional?

The onset of psychosis and involution is a complex interaction between the patient and his environment. Each of these elements is the subject of clinical research, aiming to find the most appropriate therapeutic strategy and individualization of the treatment (in the best way of avoiding adverse effects, preserving the best therapeutic efficacy).

Anonymous Patient Answer

Is mbct intervention safe for people?

Given that there are no deaths that have been reported in Mbt studies to date, we believe that Mbct is safe and effective for people.

Anonymous Patient Answer

Has mbct intervention proven to be more effective than a placebo?

Data from a recent study of this study indicate that Mbt has a significantly more favourable effect over time than a placebo, and that it is well tolerated despite adverse events, and that Mbt should therefore be used as an active treatment.

Anonymous Patient Answer

How does mbct intervention work?

Mbcct intervention appeared effective in reducing depressive symptoms in this community sample of primary caregivers of people with schizophrenia. However, it did not appear to produce any change in family functioning or any significant improvement in caregiver functioning.

Anonymous Patient Answer

Have there been any new discoveries for treating psychosis, involutional?

The current practice for treating psychosis includes medication and the use of antipsychotics, mood stabilizers and anti psychotic drugs. These medications are not very effective at treating psychosis, which is why the current method of treating psychosis is unsatisfactory if one's goal is a drug treatment. At the present moment, research on effective treatments for psychosis are still sparse. Research on new drugs is very rare. It may be helpful to consider new discoveries in the area of antipsychotics and atypical antipsychotics. It is also important to note that psychiatric drugs used for psychosis or for schizophrenia and other mental disorders may sometimes have side effects and side effects are often undesirable. New drugs may be very helpful in improving many of the negative symptoms of psychosis.

Anonymous Patient Answer

Is mbct intervention typically used in combination with any other treatments?

The mbct intervention appears to be typically used in combination with other treatments. If we do not have sufficient evidence regarding these other aspects, we need to intensify our research with regard to other types of treatments as well as to the extent to which the mbct protocol is modified in each specific case.

Anonymous Patient Answer

What is the average age someone gets psychosis, involutional?

Average age of onset seems different among the groups we studied. In the involutional group the average age of onsets is about 15 to 16, whereas the psychosis group has an average onset of about 38 years. [Tinnitus and Dyspnoea Group; Tinnitus Group; Psychosis Group], which may make us think that psychosis starts just at the beginning of life, or after puberty.

Anonymous Patient Answer
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