Trial Outcomes & Findings for Supportive and Supportive-Expressive Treatment for Depression (NCT NCT02728557)
NCT ID: NCT02728557
Last Updated: 2025-01-27
Results Overview
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-point scale depending on the specific symptom. Total score (sum score) provides an indication of depression severity. The range is 0-52
COMPLETED
NA
100 participants
Slope from baseline to week 16.
2025-01-27
Participant Flow
Participant milestones
| Measure |
Supportive-expressive Psychotherapy
Participants will receive supportive-expressive therapy.
Supportive-Expressive Therapy: Supportive-expressive psychotherapy for depressive disorder for 16 weeks.
|
Supportive Psychotherapy
Participants will receive supportive therapy.
Supportive Therapy: Supportive psychotherapy for depressive disorder for 16 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
48
|
45
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Supportive-expressive Psychotherapy
Participants will receive supportive-expressive therapy.
Supportive-Expressive Therapy: Supportive-expressive psychotherapy for depressive disorder for 16 weeks.
|
Supportive Psychotherapy
Participants will receive supportive therapy.
Supportive Therapy: Supportive psychotherapy for depressive disorder for 16 weeks.
|
|---|---|---|
|
Overall Study
Dissatisfaction with assigned treatment
|
1
|
3
|
|
Overall Study
Dissatisfaction with research tasks
|
0
|
1
|
|
Overall Study
Scheduling or change in availability
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Supportive Psychotherapy
n=50 Participants
Participants will receive supportive therapy.
Supportive Therapy: Supportive psychotherapy for depressive disorder for 16 weeks.
|
Supportive-expressive Psychotherapy
n=50 Participants
Participants will receive supportive-expressive therapy.
Supportive-Expressive Therapy: Supportive-expressive psychotherapy for depressive disorder for 16 weeks.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.02 Years
STANDARD_DEVIATION 6.9 • n=50 Participants
|
31.5 Years
STANDARD_DEVIATION 9.6 • n=50 Participants
|
31.2 Years
STANDARD_DEVIATION 8.25 • n=100 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=50 Participants
|
28 Participants
n=50 Participants
|
57 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=50 Participants
|
22 Participants
n=50 Participants
|
43 Participants
n=100 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Israel
|
50 participants
n=50 Participants
|
50 participants
n=50 Participants
|
100 participants
n=100 Participants
|
|
HRSD
|
20.84 Unit on a scale
STANDARD_DEVIATION 3.588 • n=50 Participants
|
21.00 Unit on a scale
STANDARD_DEVIATION 3.881 • n=50 Participants
|
20.92 Unit on a scale
STANDARD_DEVIATION 3.719 • n=100 Participants
|
PRIMARY outcome
Timeframe: 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-point scale depending on the specific symptom. Total score (sum score) provides an indication of depression severity. The range is 0-52
Outcome measures
| Measure |
Supportive-expressive Psychotherapy
n=50 Participants
Participants will receive supportive-expressive therapy.
Supportive-Expressive Therapy: Supportive-expressive psychotherapy for depressive disorder for 16 weeks.
|
Supportive Psychotherapy
n=50 Participants
Participants will receive supportive therapy.
Supportive Therapy: Supportive psychotherapy for depressive disorder for 16 weeks.
|
|---|---|---|
|
Hamilton Rating Scale for Depression (HRSD)
Change from baseline to week 16
|
12.32 units on a scale
Standard Deviation 6.52
|
12.06 units on a scale
Standard Deviation 6.26
|
|
Hamilton Rating Scale for Depression (HRSD)
Baseline
|
20.20 units on a scale
Standard Deviation 4.106
|
20.08 units on a scale
Standard Deviation 3.702
|
SECONDARY outcome
Timeframe: 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 16Beck 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. Scores between 14-19 indicate mild depression. Scores from 20-28 reflect moderate depression. Scores 29 and above suggest severe depression. Range 0-63
Outcome measures
| Measure |
Supportive-expressive Psychotherapy
n=50 Participants
Participants will receive supportive-expressive therapy.
Supportive-Expressive Therapy: Supportive-expressive psychotherapy for depressive disorder for 16 weeks.
|
Supportive Psychotherapy
n=50 Participants
Participants will receive supportive therapy.
Supportive Therapy: Supportive psychotherapy for depressive disorder for 16 weeks.
|
|---|---|---|
|
Beck Depression Inventory (BDI)
Change from baseline to week 16
|
16.62 units on a scale
Standard Deviation 9.63
|
13.36 units on a scale
Standard Deviation 10.59
|
|
Beck Depression Inventory (BDI)
Baseline
|
27.55 units on a scale
Standard Deviation 8.617
|
25.76 units on a scale
Standard Deviation 7.604
|
SECONDARY outcome
Timeframe: 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 16Outcome 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
Outcome measures
| Measure |
Supportive-expressive Psychotherapy
n=50 Participants
Participants will receive supportive-expressive therapy.
Supportive-Expressive Therapy: Supportive-expressive psychotherapy for depressive disorder for 16 weeks.
|
Supportive Psychotherapy
n=50 Participants
Participants will receive supportive therapy.
Supportive Therapy: Supportive psychotherapy for depressive disorder for 16 weeks.
|
|---|---|---|
|
Outcome Questionnaire (OQ)
Changes from baseline to week 16
|
32.26 units on a scale
Standard Deviation 20.54
|
26.33 units on a scale
Standard Deviation 18.44
|
|
Outcome Questionnaire (OQ)
Baseline
|
73.435 units on a scale
Standard Deviation 13.504
|
69.519 units on a scale
Standard Deviation 13.213
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 16Inventory 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 scale, ranging from 0 (not at all) to 4 (extremely). Calculated as a sum score. Range 0 -128
Outcome measures
| Measure |
Supportive-expressive Psychotherapy
n=50 Participants
Participants will receive supportive-expressive therapy.
Supportive-Expressive Therapy: Supportive-expressive psychotherapy for depressive disorder for 16 weeks.
|
Supportive Psychotherapy
n=50 Participants
Participants will receive supportive therapy.
Supportive Therapy: Supportive psychotherapy for depressive disorder for 16 weeks.
|
|---|---|---|
|
Inventory of Interpersonal Problems Circumplex (IIP-C)
Changes from baseline to week 16
|
13.38 units on a scale
Standard Deviation 15.92
|
11.94 units on a scale
Standard Deviation 12.7
|
|
Inventory of Interpersonal Problems Circumplex (IIP-C)
Baseline
|
55.58 units on a scale
Standard Deviation 12.52
|
59.32 units on a scale
Standard Deviation 15.306
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 16Experiences 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 prefer not to show a partner how I feel deep down"). The reliability and validity of these scales have been repeatedly demonstrated (Brennan et al., 1998; Mikulincer \& Shaver, 2007). The score for each subscale is calculated as the average value Range 1-7
Outcome measures
| Measure |
Supportive-expressive Psychotherapy
n=50 Participants
Participants will receive supportive-expressive therapy.
Supportive-Expressive Therapy: Supportive-expressive psychotherapy for depressive disorder for 16 weeks.
|
Supportive Psychotherapy
n=50 Participants
Participants will receive supportive therapy.
Supportive Therapy: Supportive psychotherapy for depressive disorder for 16 weeks.
|
|---|---|---|
|
Experiences in Close Relationships Questionnaire (ECR)
Anxiety - change from baseline to week 16
|
0.9 units on a scale
Standard Deviation 1.16
|
0.6 units on a scale
Standard Deviation 0.97
|
|
Experiences in Close Relationships Questionnaire (ECR)
Avoidance - change from baseline to week 16
|
0.54 units on a scale
Standard Deviation 0.87
|
0.21 units on a scale
Standard Deviation 0.79
|
|
Experiences in Close Relationships Questionnaire (ECR)
Anxiety - baseline
|
4.07 units on a scale
Standard Deviation 1.207
|
4.101 units on a scale
Standard Deviation 1.02
|
|
Experiences in Close Relationships Questionnaire (ECR)
Avoidance - baseline
|
4.202 units on a scale
Standard Deviation 1.045
|
4.036 units on a scale
Standard Deviation 1.011
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 16Quality 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
Outcome measures
| Measure |
Supportive-expressive Psychotherapy
n=50 Participants
Participants will receive supportive-expressive therapy.
Supportive-Expressive Therapy: Supportive-expressive psychotherapy for depressive disorder for 16 weeks.
|
Supportive Psychotherapy
n=50 Participants
Participants will receive supportive therapy.
Supportive Therapy: Supportive psychotherapy for depressive disorder for 16 weeks.
|
|---|---|---|
|
Quality of Life Enjoyment and Satisfaction- Short Version (Q-LES-Q)
Change from baseline to week 16
|
0.70 units on a scale
Standard Deviation 0.73
|
0.48 units on a scale
Standard Deviation 0.63
|
|
Quality of Life Enjoyment and Satisfaction- Short Version (Q-LES-Q)
Baseline
|
2.848 units on a scale
Standard Deviation 0.542
|
2.801 units on a scale
Standard Deviation 0.505
|
Adverse Events
Supportive-expressive Psychotherapy
Supportive Psychotherapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place