Major Depressive DisorderSSETDNCT02728557
Supportive and Supportive-Expressive Treatment for Depression
A study testing Supportive-Expressive Therapy and Supportive Therapy in people with Major Depressive Disorder, run by University of Haifa at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Supportive-Expressive Therapy and Supportive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Mar 2016to 17 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Roles of the Therapeutic Alliance in Understanding the Effects of Attachment Orientations on Outcome in Psychotherapy
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Supportive-Expressive Therapy, Supportive Therapy
- Keywords
- Therapeutic alliance, Psychotherapy, Psychodynamic psychotherapy, supportive-expressive treatment, Process research, Attachment theory, Attachment orientation, Mechanism of change in psychotherapy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive-Expressive TherapyBehavioural
Supportive-expressive psychotherapy for depressive disorder for 16 weeks.
Supportive TherapyBehavioural
Supportive psychotherapy for depressive disorder for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Supportive psychotherapy | Experimental | Participants will receive supportive therapy. Receives: Behavioral: Supportive Therapy |
| Supportive-expressive psychotherapy | Experimental | Participants will receive supportive-expressive therapy. Receives: Behavioral: Supportive-Expressive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Slope from baseline to week 16.
Secondary outcomes (2)
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
Measured: 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 (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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study start2 Mar 2016
- Primary completion17 Feb 2021
- Study completion17 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sigal Zilcha Mano, University of Haifa
- Investigators
- Sigal Zilcha Mano, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728557
- Sponsor's protocol ID
- ISF 186.15
- Acronym
- SSETD
- Status last verified
- Dec 2024
- First submitted
- 15 Mar 2016
- Last updated
- 27 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
PubMed 14399272Endicott J, Nee J, Harrison W, Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321-6.
PubMed 8290681Horowitz LM, Rosenberg SE, Baer BA, Ureno G, Villasenor VS. Inventory of interpersonal problems: psychometric properties and clinical applications. J Consult Clin Psychol. 1988 Dec;56(6):885-92. doi: 10.1037//0022-006x.56.6.885. No abstract available.
PubMed 3204198Leibovich L, Sadek A, Ben David-Sela T, Khoury Y, Malka M, Midgley N, Zilcha-Mano S. "I too deserve good": A qualitative exploration of corrective relational experiences in psychodynamic therapy for depression. Psychotherapy (Chic). 2026 Mar;63(1):24-32. doi: 10.1037/pst0000607. Epub 2026 Feb 12.
PubMed 41678241Zilcha-Mano S, Webb CA. Identifying who benefits most from supportive versus expressive techniques in psychotherapy for depression: Moderators of within- versus between-individual effects. J Consult Clin Psychol. 2024 Mar;92(3):187-197. doi: 10.1037/ccp0000868. Epub 2023 Dec 7.
PubMed 38059944Zilcha-Mano S, Ben David-Sela T. Is alliance therapeutic in itself? It depends. J Couns Psychol. 2022 Nov;69(6):786-793. doi: 10.1037/cou0000627. Epub 2022 Aug 4.
PubMed 35925745Zilcha-Mano S, Dolev-Amit T, Fisher H, Ein-Dor T, Strauss B. Patients' individual differences in implicit and explicit expectations from the therapist as a function of attachment orientation. J Couns Psychol. 2021 Nov;68(6):682-695. doi: 10.1037/cou0000503. Epub 2021 Jun 28.
PubMed 34180691Zilcha-Mano S, Dolev T, Leibovich L, Barber JP. Identifying the most suitable treatment for depression based on patients' attachment: study protocol for a randomized controlled trial of supportive-expressive vs. supportive treatments. BMC Psychiatry. 2018 Nov 12;18(1):362. doi: 10.1186/s12888-018-1934-1.
PubMed 30419875
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Roles of the Therapeutic Alliance in Understanding the Effects of Attachment Orientations on Outcome in Psychotherapy
- ClinicalTrials.gov ID
- NCT02728557
- Acronym / sponsor ID
- SSETD / ISF 186.15
- Conditions
- Major Depressive Disorder
- Keywords
- Therapeutic alliance, Psychotherapy, Psychodynamic psychotherapy, supportive-expressive treatment, Process research, Attachment theory, Attachment orientation, Mechanism of change in psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 2 Mar 2016 (actual)
- Primary completion
- 17 Feb 2021 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 5 Apr 2016 (estimated)
- Results
- Posted 27 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supportive psychotherapy | Experimental | Behavioral: Supportive TherapyParticipants will receive supportive therapy. |
| Supportive-expressive psychotherapy | Experimental | Behavioral: Supportive-Expressive TherapyParticipants will receive supportive-expressive therapy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive-Expressive TherapySupportive-expressive psychotherapy for depressive disorder for 16 weeks. | Behavioural | Supportive-expressive psychotherapy |
| Supportive TherapySupportive psychotherapy for depressive disorder for 16 weeks. | Behavioural | Supportive psychotherapy |
Primary outcome
Hamilton Rating Scale for Depression (HRSD)
Time frame: 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
2 secondary outcomes
Beck Depression Inventory (BDI)
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
Outcome Questionnaire (OQ)
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14399272HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
- Background: PubMed 8290681Endicott J, Nee J, Harrison W, Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321-6.
- Background: PubMed 3204198Horowitz LM, Rosenberg SE, Baer BA, Ureno G, Villasenor VS. Inventory of interpersonal problems: psychometric properties and clinical applications. J Consult Clin Psychol. 1988 Dec;56(6):885-92. doi: 10.1037//0022-006x.56.6.885. No abstract available.
- Derived from this study: PubMed 41678241Leibovich L, Sadek A, Ben David-Sela T, Khoury Y, Malka M, Midgley N, Zilcha-Mano S. "I too deserve good": A qualitative exploration of corrective relational experiences in psychodynamic therapy for depression. Psychotherapy (Chic). 2026 Mar;63(1):24-32. doi: 10.1037/pst0000607. Epub 2026 Feb 12.
- Derived from this study: PubMed 38059944Zilcha-Mano S, Webb CA. Identifying who benefits most from supportive versus expressive techniques in psychotherapy for depression: Moderators of within- versus between-individual effects. J Consult Clin Psychol. 2024 Mar;92(3):187-197. doi: 10.1037/ccp0000868. Epub 2023 Dec 7.
- Derived from this study: PubMed 35925745Zilcha-Mano S, Ben David-Sela T. Is alliance therapeutic in itself? It depends. J Couns Psychol. 2022 Nov;69(6):786-793. doi: 10.1037/cou0000627. Epub 2022 Aug 4.
- Derived from this study: PubMed 34180691Zilcha-Mano S, Dolev-Amit T, Fisher H, Ein-Dor T, Strauss B. Patients' individual differences in implicit and explicit expectations from the therapist as a function of attachment orientation. J Couns Psychol. 2021 Nov;68(6):682-695. doi: 10.1037/cou0000503. Epub 2021 Jun 28.
- Derived from this study: PubMed 30419875Zilcha-Mano S, Dolev T, Leibovich L, Barber JP. Identifying the most suitable treatment for depression based on patients' attachment: study protocol for a randomized controlled trial of supportive-expressive vs. supportive treatments. BMC Psychiatry. 2018 Nov 12;18(1):362. doi: 10.1186/s12888-018-1934-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sigal Zilcha Mano principal investigator
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive-Expressive Therapy and Supportive Therapy in people with Major Depressive Disorder, run by University of Haifa at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Rating Scale for Depression (HRSD) (time frame: Slope from baseline to week 16.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02728557, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.