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Supportive and Supportive-Expressive Treatment for Depression

The Roles of the Therapeutic Alliance in Understanding the Effects of Attachment Orientations on Outcome in Psychotherapy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02728557
Acronym
SSETD
Enrollment
100
Registered
2016-04-05
Start date
2016-03-02
Completion date
2023-10-17
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Therapeutic alliance, Psychotherapy, Psychodynamic psychotherapy, supportive-expressive treatment, Process research, Attachment theory, Attachment orientation, Mechanism of change in psychotherapy

Brief summary

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.

Detailed description

One hundred patients suffering from major depression will participate in 16 sessions of supportive-expressive treatment. Patients will be randomized to one of two conditions: one that places a greater emphasis on supportive techniques, or one that places a greater emphasis on expressive techniques. These two conditions (supportive vs. expressive) hold the potential of either complementing or counter-complementing patients' attachment orientations (e.g., for a patient with higher levels of attachment anxiety, the supportive condition is complementary while the expressive is counter-complementary; the reverse is true for a patient with higher levels of attachment avoidance). Importantly, this study will employ multiple complementary methods, which will include session-by-session self-report alliance questionnaires from both patient and therapist, as well as a cognitive task assessing patients' relationship expectations, and behavioral observations of therapist-patient interactions. This study will be the first to utilize such a combination of methodologies in psychotherapy research and the first to examine the proposed mediation model. It will also be the first to manipulate the use of techniques in order to experimentally examine whether therapeutic techniques can be utilized to develop more efficient treatment models, based on the two transdiagnostic concepts of attachment and alliance. The findings will contribute both to our understanding of the relevance of attachment theory to psychotherapy research, and to the growing empirical literature on targeting transdiagnostic concepts (here, attachment and alliance) that cut across many disorders and treatment orientations. These transdiagnostic concepts can be utilized in the move towards tailoring existing psychological interventions to specific individuals according to their attachment orientations.

Interventions

BEHAVIORALSupportive-Expressive Therapy

Supportive-expressive psychotherapy for depressive disorder for 16 weeks.

BEHAVIORALSupportive Therapy

Supportive psychotherapy for depressive disorder for 16 weeks.

Sponsors

University of Haifa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Meeting MDD diagnostic criteria using the structured clinical interviews for DSM-V and scoring more than 14 on the 17-item Hamilton rating scale for depression at two evaluations (one week apart). * 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 60 * 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

Design outcomes

Primary

MeasureTime frameDescription
Hamilton Rating Scale for Depression (HRSD)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

Secondary

MeasureTime frameDescription
Beck Depression Inventory (BDI)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 Questionnaire (OQ)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

Other

MeasureTime frameDescription
Inventory of Interpersonal Problems Circumplex (IIP-C)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
Experiences in Close Relationships Questionnaire (ECR)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
Quality of Life Enjoyment and Satisfaction- Short Version (Q-LES-Q)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

Countries

Israel

Participant flow

Participants by arm

ArmCount
Supportive Psychotherapy
Participants will receive supportive therapy. Supportive Therapy: Supportive psychotherapy for depressive disorder for 16 weeks.
50
Supportive-expressive Psychotherapy
Participants will receive supportive-expressive therapy. Supportive-Expressive Therapy: Supportive-expressive psychotherapy for depressive disorder for 16 weeks.
50
Total100

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDissatisfaction with assigned treatment13
Overall StudyDissatisfaction with research tasks01
Overall StudyScheduling or change in availability11

Baseline characteristics

CharacteristicSupportive PsychotherapySupportive-expressive PsychotherapyTotal
Age, Continuous31.02 Years
STANDARD_DEVIATION 6.9
31.5 Years
STANDARD_DEVIATION 9.6
31.2 Years
STANDARD_DEVIATION 8.25
HRSD20.84 Unit on a scale
STANDARD_DEVIATION 3.588
21.00 Unit on a scale
STANDARD_DEVIATION 3.881
20.92 Unit on a scale
STANDARD_DEVIATION 3.719
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Israel
50 participants50 participants100 participants
Sex: Female, Male
Female
29 Participants28 Participants57 Participants
Sex: Female, Male
Male
21 Participants22 Participants43 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 500 / 50
other
Total, other adverse events
0 / 500 / 50
serious
Total, serious adverse events
0 / 500 / 50

Outcome results

Primary

Hamilton Rating Scale for Depression (HRSD)

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

Time frame: Slope from baseline to week 16.

ArmMeasureGroupValue (MEAN)Dispersion
Supportive-expressive PsychotherapyHamilton Rating Scale for Depression (HRSD)Change from baseline to week 1612.32 units on a scaleStandard Deviation 6.52
Supportive-expressive PsychotherapyHamilton Rating Scale for Depression (HRSD)Baseline20.20 units on a scaleStandard Deviation 4.106
Supportive PsychotherapyHamilton Rating Scale for Depression (HRSD)Change from baseline to week 1612.06 units on a scaleStandard Deviation 6.26
Supportive PsychotherapyHamilton Rating Scale for Depression (HRSD)Baseline20.08 units on a scaleStandard Deviation 3.702
Comparison: A model with two three-way interactions of time by treatment condition by attachment orientation (Time Å\~ Treatment condition Å\~ Attachment anxiety, Time Å\~ Treatment condition Å\~ Attachment avoidance) along the lower-level effects to predict differences in the slope of change in outcome. The threshold for statistical significance was p\>0.05.p-value: 0.016MLM
Secondary

Beck Depression Inventory (BDI)

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. Scores between 14-19 indicate mild depression. Scores from 20-28 reflect moderate depression. Scores 29 and above suggest severe depression. Range 0-63

Time frame: 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

ArmMeasureGroupValue (MEAN)Dispersion
Supportive-expressive PsychotherapyBeck Depression Inventory (BDI)Change from baseline to week 1616.62 units on a scaleStandard Deviation 9.63
Supportive-expressive PsychotherapyBeck Depression Inventory (BDI)Baseline27.55 units on a scaleStandard Deviation 8.617
Supportive PsychotherapyBeck Depression Inventory (BDI)Change from baseline to week 1613.36 units on a scaleStandard Deviation 10.59
Supportive PsychotherapyBeck Depression Inventory (BDI)Baseline25.76 units on a scaleStandard Deviation 7.604
Secondary

Outcome Questionnaire (OQ)

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

Time frame: 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

ArmMeasureGroupValue (MEAN)Dispersion
Supportive-expressive PsychotherapyOutcome Questionnaire (OQ)Changes from baseline to week 1632.26 units on a scaleStandard Deviation 20.54
Supportive-expressive PsychotherapyOutcome Questionnaire (OQ)Baseline73.435 units on a scaleStandard Deviation 13.504
Supportive PsychotherapyOutcome Questionnaire (OQ)Changes from baseline to week 1626.33 units on a scaleStandard Deviation 18.44
Supportive PsychotherapyOutcome Questionnaire (OQ)Baseline69.519 units on a scaleStandard Deviation 13.213
Other Pre-specified

Experiences in Close Relationships Questionnaire (ECR)

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 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

Time frame: 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

ArmMeasureGroupValue (MEAN)Dispersion
Supportive-expressive PsychotherapyExperiences in Close Relationships Questionnaire (ECR)Anxiety - change from baseline to week 160.9 units on a scaleStandard Deviation 1.16
Supportive-expressive PsychotherapyExperiences in Close Relationships Questionnaire (ECR)Avoidance - change from baseline to week 160.54 units on a scaleStandard Deviation 0.87
Supportive-expressive PsychotherapyExperiences in Close Relationships Questionnaire (ECR)Anxiety - baseline4.07 units on a scaleStandard Deviation 1.207
Supportive-expressive PsychotherapyExperiences in Close Relationships Questionnaire (ECR)Avoidance - baseline4.202 units on a scaleStandard Deviation 1.045
Supportive PsychotherapyExperiences in Close Relationships Questionnaire (ECR)Avoidance - baseline4.036 units on a scaleStandard Deviation 1.011
Supportive PsychotherapyExperiences in Close Relationships Questionnaire (ECR)Anxiety - change from baseline to week 160.6 units on a scaleStandard Deviation 0.97
Supportive PsychotherapyExperiences in Close Relationships Questionnaire (ECR)Anxiety - baseline4.101 units on a scaleStandard Deviation 1.02
Supportive PsychotherapyExperiences in Close Relationships Questionnaire (ECR)Avoidance - change from baseline to week 160.21 units on a scaleStandard Deviation 0.79
Other Pre-specified

Inventory of Interpersonal Problems Circumplex (IIP-C)

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 scale, ranging from 0 (not at all) to 4 (extremely). Calculated as a sum score. Range 0 -128

Time frame: 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

ArmMeasureGroupValue (MEAN)Dispersion
Supportive-expressive PsychotherapyInventory of Interpersonal Problems Circumplex (IIP-C)Changes from baseline to week 1613.38 units on a scaleStandard Deviation 15.92
Supportive-expressive PsychotherapyInventory of Interpersonal Problems Circumplex (IIP-C)Baseline55.58 units on a scaleStandard Deviation 12.52
Supportive PsychotherapyInventory of Interpersonal Problems Circumplex (IIP-C)Changes from baseline to week 1611.94 units on a scaleStandard Deviation 12.7
Supportive PsychotherapyInventory of Interpersonal Problems Circumplex (IIP-C)Baseline59.32 units on a scaleStandard Deviation 15.306
Other Pre-specified

Quality of Life Enjoyment and Satisfaction- Short Version (Q-LES-Q)

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

Time frame: 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

ArmMeasureGroupValue (MEAN)Dispersion
Supportive-expressive PsychotherapyQuality of Life Enjoyment and Satisfaction- Short Version (Q-LES-Q)Change from baseline to week 160.70 units on a scaleStandard Deviation 0.73
Supportive-expressive PsychotherapyQuality of Life Enjoyment and Satisfaction- Short Version (Q-LES-Q)Baseline2.848 units on a scaleStandard Deviation 0.542
Supportive PsychotherapyQuality of Life Enjoyment and Satisfaction- Short Version (Q-LES-Q)Change from baseline to week 160.48 units on a scaleStandard Deviation 0.63
Supportive PsychotherapyQuality of Life Enjoyment and Satisfaction- Short Version (Q-LES-Q)Baseline2.801 units on a scaleStandard Deviation 0.505

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026