Unified Protocol for Depression

Phase-Based Estimates
1
Effectiveness
1
Safety
Duke University, Durham, NC
+2 More
Unified Protocol - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Depression

Study Summary

This study is evaluating whether an online treatment for depression and anxiety symptoms is feasible for individuals with limited educational attainment.

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Eligible Conditions

  • Depression
  • Mood
  • Anxiety

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Unified Protocol will improve 6 primary outcomes and 2 secondary outcomes in patients with Depression. Measurement will happen over the course of through study completion, an average of 12 weeks.

Week 12
Change Between Baseline and Post-Treatment System Usability Scale Score
Change in COPE Inventory - Avoidance Factor Score
Change in Cognitive Flexibility Inventory Score
Change in Cognitive and Affective Mindfulness Scale-Revised Score
Change in Overall Anxiety Severity and Impairment Scale Score
Change in Overall Depression Severity and Impairment Scale Score
Total Number of Referrals (Sum Score)
Weekly Change in Willingness to Refer

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Unsupported
Partially Supported

This trial requires 26 total participants across 2 different treatment groups

This trial involves 2 different treatments. Unified Protocol 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.

Partially SupportedParticipants in the partially supported arm will receive all aspects of the intervention described above, with no differences between arms for the first seven weeks of the intervention (Modules 1-6). Participants will be introduced to their study therapist in week 8, at the start of Module 7 via email. During Module 7 (exposure; weeks 8-11), participants will receive four video therapy sessions. Session content will be based on principles of exposure therapy (developing a personalized exposure hierarchy, live demonstrations of exposure exercises, in-session exposure practices, post-exposure processing, home practice assignments, and therapist feedback).
Unsupported
Behavioral
Participants in this arm will receive a 12-week Unified Protocol intervention delivered via the same web platform. Each week, participants will complete the following content: depression survey, anxiety survey, information about their symptom change over time, psychoeducational text practice exercises, home practice instructions, writing exercise, home practice worksheets. In the first week, participants will receive an emailed welcome message followed by a link to the first week's content. For every following week, participants will receive an email at the start of the week with automatically generated feedback on intervention usage, behavior change, and symptom change, as well as the link to the new week's intervention content.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Unified Protocol
2020
N/A
~210

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, an average of 12 weeks for reporting.

Who is running the study

Principal Investigator
J. B.
Jack Brooks, PhD Candidate
Duke University

Closest Location

Duke University - Durham, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
18+ years old
Fluent in reading and writing English
Internet/data plan and computer/tablet/phone access for length of study
Overall Depression Severity and Impairment Scale (ODSIS) and/or Overall Anxiety Severity and Impairment Scale (OASIS) summary score >= 8
Live in North Carolina for the duration of the study

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 depression?

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Depression may be caused by or be caused by other conditions. It may also be due to a combination of multiple causes. It is not known what specific conditions will cause depression, so it has to be treated as a condition in itself. Most cases of depression are treatable but the treatment may also lead to other problems including depression in people's families.

Unverified Answer

What are the signs of depression?

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Depression can be diagnosed and may lead to suicide. The main signs and symptoms of depression are, fatigue, depression and lethargy. Depression may cause trouble in one's daily life, not completing work, sleeping a lot or even getting out during the night. When someone is experiencing depression they need to be examined to exclude any serious, underlying cause. Psychological treatment may be necessary.\n

Unverified Answer

Can depression be cured?

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If depression is a result of a chronic illness and not a secondary effect of the disease, then treatment is not successful. Moreover, if depression is due to a secondary effect of the illness and there is only temporary relief, then treatment is successful. If long term depression is due to chronic illness and the symptoms are not secondary to the illness, then treatment is successful. To be considered successful, treatment must be continued for long enough to completely resolve the symptoms. Long-term, sustained relief may be possible if the disease is treated for the initial illness.

Unverified Answer

What are common treatments for depression?

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Cognitive behavioural therapy is a common treatment for depression and a good alternative for patients who are less compliant with antidepressant drug treatment. In addition, a combination of an antidepressant medication and CBT may afford a longer-lasting antidepressant treatment effect.

Unverified Answer

What is depression?

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Depression affects 1 in 4 people a year in the UK, with a male-to-female ratio of nearly 3 to 1. Depression is more common with old age and is linked to a significant increase in mortality and morbidity. Depression symptoms are associated with a high rates of suicide and are more common in men compared with women. The relationship between depression and mental illness and associated mortality is important. Copyright © 2015 British Psychological Society, All rights reserved.

Unverified Answer

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

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Approximately 9 to 14 percent of the general population is at risk for a depressive episode from one year to another. In women younger than 65 years most common depressive episodes may be undetected, and more frequently treated than in men.

Unverified Answer

Who should consider clinical trials for depression?

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Only 1st opinion to reach a decision on depression treatment can be the patients. They should take into account all the points listed and choose treatment according to the way of thinking and the way each symptom is felt. It is important to know that some medications can help others. We should treat people one for one, the doctors shouldn’t try to cure everybody in the same time and in one step using all treatment options answer: I had depression, and I’m not ashamed of that, I’m proud! I had it, but now I have not.

Unverified Answer

Has unified protocol proven to be more effective than a placebo?

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In a recent study, findings failed to detect the superiority of protocol as reported in other similar studies. There is, however, evidence for superiority over placebo in a subgroup of subjects with mild depression.

Unverified Answer

Is unified protocol safe for people?

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We believe that this SSC protocol is safe for patients with comorbidities with which it would be difficult for a patient to obtain a good treatment response at different medical centers. This protocol could become an easy and safe way to treat depression without a huge risk of developing severe side effects. All the patients need a comprehensive evaluation of their depression including medical history and possible medications.

Unverified Answer

Does unified protocol improve quality of life for those with depression?

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This research corroborates previous studies on the benefit of depression management plans and provides further evidence that the combination of CBT-I with a medication-guided strategy increases quality of life in people with depression. Findings from a recent study also suggest that the combined approach is potentially even more effective than the medication-guided intervention alone.

Unverified Answer

Have there been any new discoveries for treating depression?

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There have been several recent discoveries on the pathophysiological and neurochemical aspects of depression. One such discovery relates an increase in nitric oxide production to the pathophysiological changes occurring in the brain during depression.

Unverified Answer

What is the latest research for depression?

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While there are common elements in the treatment algorithms of current clinical treatments of depression, the results of clinical research and the best way of evaluating them have changed little in recent years. Despite improvements in treatment and outcomes, more and more of our patients are not treated with the first line medications recommended by the American Psychiatric Association guidelines and most major depressive disorder treatments are still underused; this might well explain why patients get worse rather than getting better. The problem of clinical inertia persists. There needs to be increased awareness among clinicians that they have an obligation to make patients take their medications. This need for a change in clinical practice is especially great in view of the fact that the more often treatment is deferred or discontinued, the more severe is the likelihood of relapse.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Depression by sharing your contact details with the study coordinator.