CLINICAL TRIAL

Message-based psychotherapy (MBP) for Melancholia

Recruiting · 18+ · All Sexes · New York, NY

This study is evaluating whether unlimited text-based psychotherapy for depression is as effective as once-a-week psychotherapy.

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About the trial for Melancholia

Eligible Conditions
Study Adherence · Depressive Disorder

Treatment Groups

This trial involves 10 different treatments. Message-based Psychotherapy (MBP) is the primary treatment being studied. Participants will be divided into 10 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Video-chat psychotherapy (VCP)
BEHAVIORAL
Experimental Group 2
Video-chat psychotherapy (VCP)
BEHAVIORAL
Experimental Group 3
Video-chat psychotherapy (VCP)
BEHAVIORAL
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Eligibility

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

Inclusion & Exclusion Checklist
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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: Change from Baseline PHQ-9 at 6 weeks and 12 weeks after treatment starts
Screening: ~3 weeks
Treatment: Varies
Reporting: Change from Baseline PHQ-9 at 6 weeks and 12 weeks after treatment starts
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Change from Baseline PHQ-9 at 6 weeks and 12 weeks after treatment starts.
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 Message-based psychotherapy (MBP) will improve 3 primary outcomes, 1 secondary outcome, and 5 other outcomes in patients with Melancholia. Measurement will happen over the course of Change from Baseline PHQ-9 at 6 weeks and 12 weeks after treatment starts.

Change in Patient Health Questionnaire (PHQ-9)
CHANGE FROM BASELINE PHQ-9 AT 6 WEEKS AND 12 WEEKS AFTER TREATMENT STARTS
Phase 2: The PHQ-9 consists of 9 depression items and one disability item. Each time is associated with a DMS symptom of depression, which the participant rates whether or not they have experienced the symptom over the last two weeks, with severity rating of 0-3. It is one of the few measures that is brief (it takes less than one minute to give) and has been found to have excellent sensitivity to change over time.
CHANGE FROM BASELINE PHQ-9 AT 6 WEEKS AND 12 WEEKS AFTER TREATMENT STARTS
Expectations about Treatment (TRS)
BASELINE
Phase 2: Expectations about treatment can influence outcomes. To assess participant expectations, we will administer the Treatment Rationale Scale (TRS), a 4-item scale administered before the 2nd and last session. The scale assesses patient expectations about the success of treatment.
BASELINE
Working Alliance Inventory (WAI)
12 WEEKS AFTER TREATMENT STARTS
Phase 2: The WAI is a 12-item measure of therapeutic alliance (relationship between the consumer and therapist or coach). It is a reliable measure of alliance, with alpha = .92.
12 WEEKS AFTER TREATMENT STARTS
Experience of Care and Health Outcomes Survey (ECHO)
12 WEEKS AFTER TREATMENT STARTS
Phase 2: ECHO items assess whether consumers received timely treatment, enough information to support self-management, and were involved in treatment as much as they wanted. ECHO is a reliable instrument with alpha = .85.
12 WEEKS AFTER TREATMENT STARTS
Treatment Use Variables
12 WEEKS AFTER TREATMENT STARTS
Phase 2: Time between patient and psychotherapist contact
12 WEEKS AFTER TREATMENT STARTS
Tailoring Variable - Clinician-Administered PHQ-9
6 WEEKS AFTER TREATMENT STARTS
Phase 2: To determine whether patients move to level II treatment we will used clinician administered PHQ9 at week 6 of treatment. Anyone falling below a 50% change in baseline PHQ9 scores will be switch to either the Platinum Plan (PP) condition or Ultimate Plan (UP) condition.
6 WEEKS AFTER TREATMENT STARTS
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Who is running the study

Principal Investigator
T. D. H.
Thomas Derrick Hull, VP, Clinical Research & Development
Talkspace

Patient Q & A Section

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

Can melancholia be cured?

Melancholia has no curative treatment; people with severe depression can die. The term 'cure' is inoffensive; it implies a medical notion of 'fixing the illness'. People do not have the 'cure' they deserve.

Anonymous Patient Answer

What are common treatments for melancholia?

Antidepressants can produce significant mood elevations. Some antidepressants also produce euphoria and psychosis. Selective serotonin reuptake inhibitors can be useful in mild depression and panic disorder. Electroconvulsive therapy (ECT) is effective in the short-term treatment of bipolar depression and treatment-resistant depression. In severe depression or psychosis, the benefits of ECT may be outweighed by adverse effects. In other severe illnesses, ECT is ineffective. Antipsychotics are used in schizophrenia for both psychotic episodes and depressive episodes. Atypical antipsychotics are preferred over classical antipsychotics because of fewer extrapyramidal side effects as well as a lower risk of cardiovascular disease and metabolic syndrome.

Anonymous Patient Answer

What is melancholia?

While no specific criteria have been established, the term'melancholia' is often used in this manner. Although the depressive phase of the depressive episode can be severe, for many individuals there are several depressive phases, sometimes with periods of elation in between. In this article, a more precise definition of what'melancholia' is is provided, and how patients might be best served by psychiatric treatments, or a combination of both. It is also discussed how our understanding of depression has evolved over recent decades.

Anonymous Patient Answer

What are the signs of melancholia?

Signs of melancholia are more akin to those of depression. The melancholic state has feelings of sadness and despairing mood. Subjective symptoms of melancholy could include suicidal thoughts along with increased anxiety or irritability. Although they appear similar, they are not the same.\n

Anonymous Patient Answer

How many people get melancholia a year in the United States?

Up to 75 million US adults may be suffering from a depressive episode a year. This is a substantial problem as about 10% of all US adult inpatient admissions are related to depression.

Anonymous Patient Answer

What causes melancholia?

Current beliefs about melancholia may be biased by the social expectations of psychiatrists. As with many common psychiatric diagnoses, there is a shortage of research on the causes and symptomatology of melancholia.

Anonymous Patient Answer

Is message-based psychotherapy (mbp) safe for people?

This is the first prospective randomized controlled trial that has found Mbt to be safe. This trial, along with an expanding body of evidence, suggests that MBT can be a helpful complementary intervention.

Anonymous Patient Answer

What is the latest research for melancholia?

The recent literature is rich with research studies regarding the neurochemistry of melancholic patients. Although there are several factors that may influence the onset of melancholia, there are still some unanswered questions. It will be extremely important to clarify why only some patients feel overwhelmed by the stress of certain events or circumstances, while others feel no stress and are more resilient. Scientists need to work tirelessly to discover the precise neuro-chemical makeup in the brains of melancholic patients.

Anonymous Patient Answer

Does melancholia run in families?

Based on the results of our study we conclude that familial occurrence of melancholic features is not restricted to bipolar depression, but can also be an isolated trait.

Anonymous Patient Answer

What are the latest developments in message-based psychotherapy (mbp) for therapeutic use?

mbp is being developed for a variety of clinical, psychosocial, organizational, and individual purposes. The focus of mbp is to improve outcomes in both the individual and organizational domains. Mbn’s unique structure has the potential to improve outcomes for all users.

Anonymous Patient Answer

What does message-based psychotherapy (mbp) usually treat?

MBP is based on a cognitive, existential, interpersonal, and psychological account of the illness and it is suggested as a first line treatment for depressive disorders.

Anonymous Patient Answer

How serious can melancholia be?

Patients with melancholia can present with significant distress and impairment, even in a mild sub-clinical form. Therefore, depression and anxiety are serious medical conditions that deserve attention on both sides of the equator. However, some studies and the Brazilian guidelines on depression recommend that the diagnosis of a depressive disorders to always include a melancholic syndrome. In addition, treatment algorithms based on melancholia were defined in clinical guidelines, but they recommend the use of depression treatment based on the most current recommendations. More research is needed in order to define the optimal treatment for these patients.

Anonymous Patient Answer
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