NCT02728557: SSETD

Supportive and Supportive-Expressive Treatment for Depression

Completed NA Results posted Last updated 27 January 2025

What this trial tests

NA trial testing Supportive-Expressive Therapy in Major Depressive Disorder in 100 participants. Completed in 17 October 2023.

Timeline

2 March 2016

Primary endpoint
17 February 2021

17 October 2023

Quick facts

Lead sponsor	University of Haifa
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	100
Start date	2 March 2016
Primary completion	17 February 2021
Estimated completion	17 October 2023
Sites	1 location across Israel

Drugs / interventions tested

• Supportive-Expressive Therapy
• Supportive Therapy

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

University of Haifa

Who can join

Adults 18 to 60, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hamilton Rating Scale for Depression (HRSD) Primary · Slope from baseline to week 16.

A clinically administered measure assessing the severity of depression. The Hamilton is the standard measure of depression severity for clinical trials. The scoring is based on the first 17-items of the Hamilton. 0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression \>=23 = Very Severe Depression Hamilton Rating Scale for Depression, developed by Max Hamilton in 1967, is a widely used tool for assessing the severity of depression in adults. 17 items covering various aspects of depression experienced in the past week. Each item is rated on a 3-point or 5

Change from baseline to week 16

Group	Value	95% CI
Supportive-expressive Psychotherapy	12.32	± 6.52
Supportive Psychotherapy	12.06	± 6.26

Baseline

Group	Value	95% CI
Supportive-expressive Psychotherapy	20.20	± 4.106
Supportive Psychotherapy	20.08	± 3.702

Beck Depression Inventory (BDI) Secondary · Slope from baseline to week 16. Measured at baseline, every week for 16 weeks of treatment, then once a month for four months and follow up after a year; Scores are provided for baseline and change from baseline to week 16

Beck Depression Inventory; measuring depression by a self-report measure; higher means worse outcomes. The Beck Depression Inventory consists of 21 multiple-choice questions. Each question presents different statements reflecting varying intensities of a particular depressive symptom. Each question has scores ranging from 0 (no symptoms) to 3 (most severe symptoms). The total score is obtained by summing up the scores of all chosen responses. Based on the total score, there are different interpretations of depression severity: Scores in the 0-13 range suggest minimal or no depression. Sco

Change from baseline to week 16

Group	Value	95% CI
Supportive-expressive Psychotherapy	16.62	± 9.63
Supportive Psychotherapy	13.36	± 10.59

Baseline

Group	Value	95% CI
Supportive-expressive Psychotherapy	27.55	± 8.617
Supportive Psychotherapy	25.76	± 7.604

Outcome Questionnaire (OQ) Secondary · Slope from baseline to week 16. Measured at baseline, every week for 16 weeks of treatment, then once a month for four months and follow up after a year; Scores are provided for baseline and change from baseline to week 16

Outcome Questionnaire; measuring Symptom Distress, Interpersonal Relationships, Social Role; higher levels mean worse outcome. Outcome Questionnaire-30 (OQ-30; Lambert et al., 1996). OQ-30 is a 30-item self-report measure assessing distress, designed to measure patient progress. Items were rated on a 5 point likert scale ranging from 0 (never) to 4 (almost always). The OQ-30 has three subscales assessing symptom distress, interpersonal relations, and social role performance. A total score is calculated by sum scores. Range 0-120

Changes from baseline to week 16

Group	Value	95% CI
Supportive-expressive Psychotherapy	32.26	± 20.54
Supportive Psychotherapy	26.33	± 18.44

Baseline

Group	Value	95% CI
Supportive-expressive Psychotherapy	73.435	± 13.504
Supportive Psychotherapy	69.519	± 13.213

Inventory of Interpersonal Problems Circumplex (IIP-C) Secondary · Measured at baseline, six times during the treatment (weeks 1, 2, 4, 8, 12, 16), then once a month for four months and follow up after a year; reports refer to baseline and changes from baseline to week 16

Inventory of Interpersonal Problems Circumplex; measuring interpersonal problems; higher means worse outcomes Inventory of Interpersonal Problems-Circumplex (IIP-C). The IIP-C is a 32-item self-report questionnaire assessing interpersonal difficulties and distress. Patients rate two types of items: interpersonal behaviors that are "hard for you to do" (e.g., "it is hard for me to let other people know when I am angry") and interpersonal behaviors that "you do too much" (e.g., "I am too afraid of other people"). Ratings of the degree to which each problem is distressing are made on a 5-point

Changes from baseline to week 16

Group	Value	95% CI
Supportive-expressive Psychotherapy	13.38	± 15.92
Supportive Psychotherapy	11.94	± 12.7

Baseline

Group	Value	95% CI
Supportive-expressive Psychotherapy	55.58	± 12.52
Supportive Psychotherapy	59.32	± 15.306

Experiences in Close Relationships Questionnaire (ECR) Secondary · Measured at baseline, six times during the treatment (weeks 1, 2, 4, 8, 12, 16), then once a month for four months and follow up after a year; reports refer to baseline and changes from baseline to week 16

Experiences in Close Relationships Questionnaire; The measurement data will be aggregated into two sub-scales: anxiety and avoidance; higher scores mean worse outcomes (less secure attachment) Experience in Close Relationships Scale (ECR; Brennan et al., 1998). 36-item self-reported measure. Participants rated the extent to which each item was descriptive of their experiences in close relationships on a 7-point Likert scale ranging from 1 (not at all) to 7 (very much). 18 items assessed attachment anxiety (e.g., "I worry about being abandoned"). 18 assessed attachment avoidance (e.g., "I pref

Anxiety - change from baseline to week 16

Group	Value	95% CI
Supportive-expressive Psychotherapy	0.9	± 1.16
Supportive Psychotherapy	0.6	± 0.97

Avoidance - change from baseline to week 16

Group	Value	95% CI
Supportive-expressive Psychotherapy	0.54	± 0.87
Supportive Psychotherapy	0.21	± 0.79

Anxiety - baseline

Group	Value	95% CI
Supportive-expressive Psychotherapy	4.07	± 1.207
Supportive Psychotherapy	4.101	± 1.02

Avoidance - baseline

Group	Value	95% CI
Supportive-expressive Psychotherapy	4.202	± 1.045
Supportive Psychotherapy	4.036	± 1.011

Quality of Life Enjoyment and Satisfaction- Short Version (Q-LES-Q) Secondary · Measured at baseline, six times during the treatment (weeks 1, 2, 4, 8, 12, 16), then once a month for four months and follow up after a year; reports refer to baseline and change from baseline to week 16

Quality of Life Enjoyment and Satisfaction- Short Version; measuring quality of life; higher scores mean better outcomes. The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). It's a self-report measure, meaning the person being assessed completes the questionnaire themselves. Purpose: It gauges the degree of enjoyment and satisfaction a person experiences in different areas of their daily functioning. Utilize a 5-point Likert scale, ranging from 1 (very poor) to 5 (very good). Higher scores mean better outcomes. Range 1-5. Average score

Change from baseline to week 16

Group	Value	95% CI
Supportive-expressive Psychotherapy	0.70	± 0.73
Supportive Psychotherapy	0.48	± 0.63

Baseline

Group	Value	95% CI
Supportive-expressive Psychotherapy	2.848	± 0.542
Supportive Psychotherapy	2.801	± 0.505

Sponsor's own description

This study will assign patients to two types of psychotherapies in treating people with a major depression disorder, expressive versus supportive techniques, and will examine their ability to benefit from treatment based on their attachment orientation. This is a four month protocol, with a year follow up period, will compare patients receiving supportive-expressive treatment with either expressive focus or supportive focus.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Identifying the most suitable treatment for depression based on patients' attachment: study protocol for a randomized controlled trial of supportive-expressive vs. supportive treatments.
   Zilcha-Mano S, Dolev T, Leibovich L, Barber JP. · · 2018 · cited 24× · PMID 30419875 · DOI 10.1186/s12888-018-1934-1
2. Identifying who benefits most from supportive versus expressive techniques in psychotherapy for depression: Moderators of within- versus between-individual effects.
   Zilcha-Mano S, Webb CA. · · 2024 · cited 5× · PMID 38059944 · DOI 10.1037/ccp0000868
3. Contrasting Individual-Specific Resilience and Compensation Personalization Frameworks: The Case of Rumination.
   Zilcha-Mano S. · · 2025 · cited 1× · PMID 40256214 · DOI 10.1016/j.bpsgos.2025.100478
4. Therapeutic Change May Begin before the Therapist and Patient Ever Meet: Pretreatment Alliance Changes Predict Clinical Outcomes.
   Zilcha-Mano S. · · 2025 · PMID 41252327 · DOI 10.1159/000548510