Standard psychiatry and cognitive behavioral online intervention for Melancholia

Phase-Based Estimates
1
Effectiveness
1
Safety
York University, Toronto, Canada
Melancholia+3 More
Standard psychiatry and cognitive behavioral online intervention - Behavioral
Eligibility
18 - 65
All Sexes
Eligible conditions
Melancholia

Study Summary

This study is evaluating whether a combination of online CBT and mindfulness meditation is as effective as in-person CBT for people with depression.

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Eligible Conditions

  • Melancholia
  • Depressive Disorder
  • Psychosis, Involutional
  • Depression
  • Depressive Disorder, Major
  • Major Depressive Disorder (MDD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Standard psychiatry and cognitive behavioral online intervention will improve 1 primary outcome and 6 secondary outcomes in patients with Melancholia. Measurement will happen over the course of Baseline and 4 months.

Baseline and 4 months
Change in 5-Facet Mindfulness Questionnaire - 39-item version (39 to 195 - higher score indicates better outcome) Five-Facet Mindfulness Questionnaire
Change in Beck Anxiety Inventory (0 to 63 - higher score indicates worse outcome)
Change in Beck Depression Inventory - 2 (0 to 63 - higher score indicates worse outcome)
Change in Brief Pain Inventory - 11 item (0 - 176 - high score indicates worse outcome)
Change in EQ-5D Quality of Life Instrument - 5 items - 0 - 25 - high score - worse outcome)
Change in Hamilton Depression Rating Scale - 24-item version (0 to 72) Hamilton Depression Rating Scale - 24 item (0 - 96 - higher score indicates worse outcome)
Change in Quick Inventory of Depressive Symptoms (0 to 48 - higher score indicates worse outcome)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Standard psychiatry and cognitive behavioural in-person intervention
Standard psychiatry and cognitive behavioural online intervention

This trial requires 156 total participants across 2 different treatment groups

This trial involves 2 different treatments. Standard Psychiatry And Cognitive Behavioral Online 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.

Standard psychiatry and cognitive behavioural online intervention
Behavioral
The online group CBT-M program combines software-based workbooks with phone-based Navigator-Coaching that coordinates software interactions (e.g., secure text messaging, Fitbit tracked walking, food monitoring via photography). Navigation coaching is supplied by students who were pursuing graduate degrees (MSc, MA, PhD) in kinesiology and health science, education, and psychology.
Standard psychiatry and cognitive behavioural in-person intervention
Behavioral
The on-site, usual-care CBT group follows the structure of the Mind Over Mood workbook in reviewing CBT concepts and procedures. A series of work sheets assist participants in differentiating moods, and in differentiating moods from thoughts and situational influences, leading to modifications of thinking, behaviour, emotion and mood. Group leaders are standard leaders in the CAMH group-CBT program who have Masters-level degrees in psychology, social work and occupational therapists.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 4 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline and 4 months for reporting.

Who is running the study

Principal Investigator
P. R.
Paul Ritvo, Co-Principal Investigator
York University

Closest Location

York University - Toronto, Canada

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Beck Depression Inventory-II of at least mild severity (BDI-II score ≥ 14) with no upper severity limit;
Psychiatrist diagnosis of Major Depression Disorder;
MINI International Neuropsychiatric Interview-confirmed diagnosis of Major Depression Disorder;
fluent in English.

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 melancholia?

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A large number of other conditions and symptoms may co-exist with a diagnosis of depression and thus be considered as comorbidities as well as being associated with depression in their own right. Different diagnostic criteria for comorbid depression exist. Because of this, the term ‘depression with melancholia’ has become an umbrella term with no clear line separating these two conditions.

Unverified Answer

What is melancholia?

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melancholia is a mood disorder that occurs in adolescence and has an onset age of 14 to 21 years. Affected individuals tend to have poor functioning at work and school and to have more disability as well as more hopelessness while feeling depressed. They also have more trouble in interpersonal relationships and emotional regulation. People diagnosed with melancholia experience emotional changes including: low energy, sleepiness, hypersomnia, and lethargy. They are often irritable and are more depressed.

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

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M.I.N.G.E., a popular treatment for depression with a more favourable side effect profile than SSRIs or TCAs, has been studied in more than 200 clinical trials in over 10,000 patients. It has been shown to improve symptoms of depression, as well as symptoms of other mental health problems such as major depression, dysthymia, bipolar disorder, obsessive-compulsive disorder (OCD), and anxiety disorders. The antidepressant discontinuation syndrome is very rare and usually appears within 4 weeks of stopping treatment when patients are not taking the medication regularly as a pill. The cause has not been clarified.

Unverified Answer

Can melancholia be cured?

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Melancholia is generally reversible and may be cured using a combination of cognitive and behavioral therapy. The potential for the treatment of depressive disorders in general is uncertain, however.

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What are common treatments for melancholia?

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Although the treatments mentioned are only part of the full list, they seem to fall into the same categories as the treatments discussed in the treatment part. The treatments that have most success are antidepressants and electroconvulsive therapy with ECT seeming to be most successful. Medication with anxiolytics and mood stabilizers appear to be quite successful, but with antidepressant-like or anxiolytic-like effects at lower doses. Other treatments that have been described are a combination of all the above treatments. However, no studies examining the efficacy of medications have been undertaken and the results in different studies were inconsistent - no conclusions could be made with regards to the efficacy of medications.

Unverified Answer

What are the signs of melancholia?

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The signs of depression in the early stage of the disease can be identified as the same as those of major depressive disorder (MDD). However, as the disease advances, the symptoms of the disease, such as insomnia, forgetfulness, and low mood are more predominant than those of MDD.

Unverified Answer

What is standard psychiatry and cognitive behavioral online intervention?

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The Internet can be useful in educating participants about depression and in facilitating the collection of symptom-related information that is important to the formation of a depressed diagnosis.

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What is the primary cause of melancholia?

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Anxiety does not appear to be a key factor in determining the primary subtype of melancholia: melancholic patients with panic disorders appear to have more generalized, and not anxiety-based, symptoms and to have greater impairment in functioning in their daily lives. Future studies need to examine the presence of subthreshold anxiety symptoms in melancholic patients without panic disorder and further examine the contribution of anxiety symptoms to the subtype of melancholia.

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What does standard psychiatry and cognitive behavioral online intervention usually treat?

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Online interventions have a long history of use in treating psychiatric conditions, particularly in the treatment of major depression. However, the evidence for such uses is weak. The evidence for the use of CBT for anxiety disorders is weak and the evidence for the use of CBT for eating disorders is inconclusive.

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Have there been any new discoveries for treating melancholia?

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Though not all patients respond to antidepressants, there has been at least one new discovery for treating melancholia in recent years. There is still no consensus as to the specific treatment. It remains a difficult diagnosis but has some interesting new therapies for treating it.

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Is standard psychiatry and cognitive behavioral online intervention typically used in combination with any other treatments?

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In line with the growing evidence base for MBC and the limited evidence base for the use of CBT delivered online, this survey provides valuable data on the frequency of use of CBT, psychotherapy and antidepressant treatment in conjunction with mental health treatment during the year 2015-2016. This survey does not cover treatment for social anxiety/agoraphobia, substance use disorders or anorexia in patients from other than Western countries.

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What is the latest research for melancholia?

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The most current scientific reviews and meta-analyses of antidepressant treatment effects on major depression, anxiety and mood are available. A majority of these reviews concluded that antidepressant treatment did not reduce the risk of subsequent depression, anxiety or mood instability.

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