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Supportive-Expressive and Emotion-Focused Treatment for Depression (SETEFT)

Primary Purpose

Major Depressive Disorder

Status
Recruiting
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Supportive-expressive treatment
Emotions-Focused treatment
Sponsored by
University of Haifa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Psychotherapy, Mechanism of change, supportive-expressive treatment, Emotion-Focused Therapy, Psychodynamic psychotherapy, Insight, emotional processing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of HaifaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Supportive-Expressive

Emotion-Focused

Arm Description

Participants will receive supportive-expressive treatment for 16 weeks.

Participants will receive Emotion-Focused treatment for 16 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Weekly change in Beck Depression Inventory (BDI)
A 21-item, self-rated scale that evaluates key symptoms of depression. Higher scores indicate worse outcome.
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.
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.
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.

Full Information

First Posted
September 26, 2020
Last Updated
February 25, 2023
Sponsor
University of Haifa
Collaborators
Israel Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04576182
Brief Title
Supportive-Expressive and Emotion-Focused Treatment for Depression
Acronym
SETEFT
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2020 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Haifa
Collaborators
Israel Science Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Psychotherapy, Mechanism of change, supportive-expressive treatment, Emotion-Focused Therapy, Psychodynamic psychotherapy, Insight, emotional processing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double Blind (participants, outcome assessor)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supportive-Expressive
Arm Type
Experimental
Arm Description
Participants will receive supportive-expressive treatment for 16 weeks.
Arm Title
Emotion-Focused
Arm Type
Experimental
Arm Description
Participants will receive Emotion-Focused treatment for 16 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Supportive-expressive treatment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Emotions-Focused treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weekly change in Hamilton rating scale for depression (HRSD)
Description
A 17-item clinically administered measure assessing the severity of depression. Higher scores indicate worse outcome.
Time Frame
up to 16 weeks.
Secondary Outcome Measure Information:
Title
Weekly change in Beck Depression Inventory (BDI)
Description
A 21-item, self-rated scale that evaluates key symptoms of depression. Higher scores indicate worse outcome.
Time Frame
up to 16 weeks
Title
Weekly change in Outcome Questionnaire (OQ)
Description
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
Title
Trajectories of change in Inventory of Interpersonal Problems (IIP-32)
Description
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)
Title
trajectories of change in Quality of Life Enjoyment and Satisfaction- Short Version (Q-LES-Q)
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sigal Zilcha-Mano, PhD
Phone
972-8249047
Email
sigalzil@gmail.com
Facility Information:
Facility Name
University of Haifa
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sigal Zilcha-Mano, PhD
Phone
972-8249047
Email
sigalzil@gmail.com
First Name & Middle Initial & Last Name & Degree
Tohar Dolev-Amit, M.A.
Phone
972-8249047
Email
tohardolev@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will not be shared due to ethical reasons.
Citations:
PubMed Identifier
34078324
Citation
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.
Results Reference
derived

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Supportive-Expressive and Emotion-Focused Treatment for Depression

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