- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04576182
Supportive-Expressive and Emotion-Focused Treatment for Depression (SETEFT)
May 3, 2026 updated by: Sigal Zilcha Mano, University of Haifa
Investigating Mechanisms of Change in Supportive-Expressive vs. Emotion-Focused Treatment of Depression Using a Personalized Treatment Approach: The Case of the Theories of Weakness vs. Strength
This study will explore the mechanisms of change that are activated when individuals receive a treatment that targets their weakness and the mechanisms activated when the treatment capitalize on their strength.
Patients will be assigned to one of two types of psychotherapies in treating people with a major depression disorder, expressive-supportive vs. emotion-focused treatment.
Their ability to benefit from treatment based on their pre-treatment levels of insight and emotional processing will be examined.
This is a four-month protocol, with a 2 year follow up period.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
One hundred and twenty-four patients suffering from major depressive disorder will be randomized to participate in 16 sessions of either supportive-expressive therapy or emotion-focused therapy.
The two treatments are theorized to differ in their main mechanism of change: supportive-expressive therapy places emphasis on insight as its main mechanism of change, and emotion-focused therapy places emphasis on emotional processing as its main mechanism of change.
Both can serve as strength- or weakness-focused treatments, based on the patient's baseline levels of insight and emotional processing.
Importantly, this study will employ multiple complementary methods, which will include session-by-session self-report questionnaires from both patient and therapist, as well as interdisciplinary measures based on hormonal and acoustic measures, cognitive tasks, clinician interviews, and behavioral coding systems to complement the self-report measures.
In addition, prior the beginning of treatment patients will complete diaries via mobile survey application.
The findings will contribute to the research on personalized mechanisms of change and can help clinicians focus on more efficient treatment delivery, adapted to given subpopulations of patients, according to their strengths and weaknesses.
If a mechanism most likely to stimulate change for a subpopulation is identified, a corresponding treatment can be chosen that is most likely to activate that particular mechanism and by that improve the rate of patients' respondent to treatment.
Study Type
Interventional
Enrollment (Estimated)
124
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sigal Zilcha-Mano, PhD
- Phone Number: 972-8249047
- Email: sigalzil@gmail.com
Study Locations
-
-
-
Haifa, Israel
- Recruiting
- University of Haifa
-
Contact:
- Sigal Zilcha-Mano, PhD
- Phone Number: 972-8249047
- Email: sigalzil@gmail.com
-
Contact:
- Tohar Dolev-Amit, M.A.
- Phone Number: 972-8249047
- Email: tohardolev@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Meeting major depressive disorder diagnostic criteria using the structured clinical interviews for Diagnostic and Statistical Manual of Mental Disorders-5 and scoring more than 14 on the 17-item Hamilton rating scale for depression at two evaluations (one week apart) (Hamilton, 1967).
- If on medication, patients' dosage must be stable for at least three months prior to entering the study, and they must be willing to maintain stable dosage for the duration of treatment
- Age between 18 and 65
- Hebrew language fluency
- Provision of written informed consent.
Exclusion Criteria:
- Current risk of suicide or self-harm
- current substance abuse disorders
- current or past schizophrenia or psychosis, bipolar disorder, or severe eating disorder requiring medical monitoring
- history of organic mental disease
- currently in psychotherapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supportive-Expressive
Participants will receive supportive-expressive treatment for 16 weeks.
|
Sixteen weeks of a time-limited psychodynamic therapy adapted for depression that includes the use of expressive techniques, such as interpretation, confrontation, clarification and the use of supportive techniques, such as affirmation and empathic validation.
This treatment postulates insight as its core mechanism of change.
|
|
Experimental: Emotion-Focused
Participants will receive Emotion-Focused treatment for 16 weeks.
|
Sixteen weeks of a brief experiential therapy for depression that combine client-centered relational elements (unconditional positive regard, congruence, and empathy) with marker-guided experiential interventions designed to facilitate and deepen emotional processing and emotion regulation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weekly change in Hamilton rating scale for depression (HRSD)
Time Frame: up to 16 weeks.
|
A 17-item clinically administered measure assessing the severity of depression.
Higher scores indicate worse outcome.
|
up to 16 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weekly change in Beck Depression Inventory (BDI)
Time Frame: up to 16 weeks
|
A 21-item, self-rated scale that evaluates key symptoms of depression.
Higher scores indicate worse outcome.
|
up to 16 weeks
|
|
Weekly change in Outcome Questionnaire (OQ)
Time Frame: up to 16 weeks
|
A 30 items self-report measure designed to assess patient therapy outcomes on three primary dimensions: (a) subjective discomfort, (b) interpersonal relationships, and (c) social role performance.
Higher scores indicate worse outcome.
|
up to 16 weeks
|
|
Trajectories of change in Inventory of Interpersonal Problems (IIP-32)
Time Frame: At intake and 6 times during the treatment (weeks 1, 2, 4, 8, 12, 16)
|
A 32-item self-report measure designed to assess interpersonal problems.
Each item is rated in terms of how distressing the problem is for the individual on a scale ranging from 0 (not at all) to 4 (extremely).
Higher scores indicate worse outcome.
|
At intake and 6 times during the treatment (weeks 1, 2, 4, 8, 12, 16)
|
|
trajectories of change in Quality of Life Enjoyment and Satisfaction- Short Version (Q-LES-Q)
Time Frame: At intake and 6 times during the treatment (weeks 1, 2, 4, 8, 12, 16)
|
Quality of Life Enjoyment and Satisfaction Scale.
Higher scores indicate better outcome.
|
At intake and 6 times during the treatment (weeks 1, 2, 4, 8, 12, 16)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 29, 2020
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
May 31, 2027
Study Registration Dates
First Submitted
September 26, 2020
First Submitted That Met QC Criteria
October 5, 2020
First Posted (Actual)
October 6, 2020
Study Record Updates
Last Update Posted (Actual)
May 7, 2026
Last Update Submitted That Met QC Criteria
May 3, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISF 395/19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data will not be shared due to ethical reasons.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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