Major Depressive DisorderSETEFTNCT04576182
Supportive-Expressive and Emotion-Focused Treatment for Depression
A study testing Supportive-expressive treatment and Emotions-Focused treatment in people with Major Depressive Disorder, run by University of Haifa at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Supportive-expressive treatment and Emotions-Focused treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteIsrael
- Study dates
- 29 Nov 2020to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
University of Haifa
Haifa
Sigal Zilcha-Mano, PhD, 972-8249047, sigalzil@gmail.com
Tohar Dolev-Amit, M.A., 972-8249047, tohardolev@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Supportive-expressive treatment, Emotions-Focused treatment
- Keywords
- Psychotherapy, Mechanism of change, supportive-expressive treatment, Emotion-Focused Therapy, Psychodynamic psychotherapy, Insight, emotional processing
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive-expressive treatmentBehavioural
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.
Emotions-Focused treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Supportive-Expressive | Experimental | Participants will receive supportive-expressive treatment for 16 weeks. Receives: Behavioral: Supportive-expressive treatment |
| Emotion-Focused | Experimental | Participants will receive Emotion-Focused treatment for 16 weeks. Receives: Behavioral: Emotions-Focused treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly change in Hamilton rating scale for depression (HRSD)
A 17-item clinically administered measure assessing the severity of depression. Higher scores indicate worse outcome.
Measured: up to 16 weeks.
Secondary outcomes (4)
Weekly change in Beck Depression Inventory (BDI)
A 21-item, self-rated scale that evaluates key symptoms of depression. Higher scores indicate worse outcome.
Measured: up to 16 weeks
Weekly change in Outcome Questionnaire (OQ)
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.
Measured: up to 16 weeks
Trajectories of change in Inventory of Interpersonal Problems (IIP-32)
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.
Measured: 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)
Quality of Life Enjoyment and Satisfaction Scale. Higher scores indicate better outcome.
Measured: At intake and 6 times during the treatment (weeks 1, 2, 4, 8, 12, 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start29 Nov 2020
- Primary completion30 Nov 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- Israel Science Foundation
- Responsible party
- Principal investigator, Sigal Zilcha Mano, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576182
- Sponsor's protocol ID
- ISF 395/19
- Acronym
- SETEFT
- Status last verified
- May 2026
- First submitted
- 26 Sep 2020
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared due to ethical reasons.
Publications
Zilcha-Mano S, Shahar B, Fisher H, Dolev-Amit T, Greenberg LS, Barber JP. Investigating patient-specific mechanisms of change in SET vs. EFT for depression: study protocol for a mechanistic randomized controlled trial. BMC Psychiatry. 2021 Jun 2;21(1):287. doi: 10.1186/s12888-021-03279-y.
PubMed 34078324
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04576182
- Acronym / sponsor ID
- SETEFT / ISF 395/19
- Conditions
- Major Depressive Disorder
- Keywords
- Psychotherapy, Mechanism of change, supportive-expressive treatment, Emotion-Focused Therapy, Psychodynamic psychotherapy, Insight, emotional processing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- Israel Science Foundation
- Study start
- 29 Nov 2020 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 6 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Supportive-Expressive | Experimental | Behavioral: Supportive-expressive treatmentParticipants will receive supportive-expressive treatment for 16 weeks. |
| Emotion-Focused | Experimental | Behavioral: Emotions-Focused treatmentParticipants will receive Emotion-Focused treatment for 16 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive-expressive treatmentSixteen 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. | Behavioural | Supportive-Expressive |
| Emotions-Focused treatmentSixteen 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. | Behavioural | Emotion-Focused |
Primary outcome
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.
4 secondary outcomes
Weekly change in Beck Depression Inventory (BDI)
Time frame: up to 16 weeks
Weekly change in Outcome Questionnaire (OQ)
Time frame: 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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Derived from this study: PubMed 34078324Zilcha-Mano S, Shahar B, Fisher H, Dolev-Amit T, Greenberg LS, Barber JP. Investigating patient-specific mechanisms of change in SET vs. EFT for depression: study protocol for a mechanistic randomized controlled trial. BMC Psychiatry. 2021 Jun 2;21(1):287. doi: 10.1186/s12888-021-03279-y.
- Individual participant dataSharing planned: No. Data will not be shared due to ethical reasons.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive-expressive treatment and Emotions-Focused treatment in people with Major Depressive Disorder, run by University of Haifa at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sigal Zilcha-Mano, PhD (972-8249047, sigalzil@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly change in Hamilton rating scale for depression (HRSD) (time frame: up to 16 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04576182, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.