CClinicalTrials.gg
RecruitingNCT04576182SETEFTUpdated May 7, 2026

Supportive-Expressive and Emotion-Focused Treatment for Depression

An interventional study of Supportive-expressive treatment and Emotions-Focused treatment in Major Depressive Disorder, sponsored by University of Haifa. Recruiting at 1 site in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-07.

Sponsored by University of Haifa · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2020; still recruiting 5 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Major Depressive Disorder

Keywords

  • Psychotherapy
  • Mechanism of change
  • supportive-expressive treatment
  • Emotion-Focused Therapy
  • Psychodynamic psychotherapy
  • Insight
  • emotional processing
03

In context

Depressive Disorder, Major

2,740 studies on the registry are indexed under Depressive Disorder, Major; 558 are open to participants now.

This study's planned enrollment of 124 is above the median of 80 across 2,282 interventional studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

University of Haifa is the lead sponsor of 101 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
124 participants (estimated)

Study arms

  • Experimental
    Supportive-Expressive

    Participants will receive supportive-expressive treatment for 16 weeks.

    Behavioral: Supportive-expressive treatment

  • Experimental
    Emotion-Focused

    Participants will receive Emotion-Focused treatment for 16 weeks.

    Behavioral: Emotions-Focused treatment

Interventions

  • BehavioralSupportive-expressive treatment

    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.

  • BehavioralEmotions-Focused treatment

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 16 weeks.

Secondary outcomes

  1. Weekly change in Beck Depression Inventory (BDI)

    A 21-item, self-rated scale that evaluates key symptoms of depression. Higher scores indicate worse outcome.

    Time frame: up to 16 weeks

  2. 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.

    Time frame: up to 16 weeks

  3. 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.

    Time frame: At intake and 6 times during the treatment (weeks 1, 2, 4, 8, 12, 16)

  4. 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.

    Time frame: At intake and 6 times during the treatment (weeks 1, 2, 4, 8, 12, 16)

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No — Data will not be shared due to ethical reasons.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04576182
Lead sponsor
University of Haifa
Collaborators
Israel Science Foundation
Responsible party
Sigal Zilcha Mano (Associate Professor, University of Haifa) — Principal investigator
First posted
Oct 6, 2020
Start date
Nov 29, 2020
Primary completion
Nov 30, 2026 (estimated)
Completion
May 31, 2027 (estimated)
Last update
May 7, 2026

Study contacts

Sigal Zilcha-Mano, PhD
Contact
sigalzil@gmail.com
972-8249047

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion