Supportive and Supportive-Expressive Treatment for Depression (SSETD)
Primary Purpose
Major Depressive Disorder
Status
Active
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Supportive-Expressive Therapy
Supportive Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Therapeutic alliance, Psychotherapy, Psychodynamic psychotherapy, supportive-expressive treatment, Process research, Attachment theory, Attachment orientation, Mechanism of change in psychotherapy
Eligibility Criteria
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
Sites / Locations
- University of Haifa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Supportive psychotherapy
Supportive-expressive psychotherapy
Arm Description
Participants will receive supportive therapy.
Participants will receive supportive-expressive therapy.
Outcomes
Primary Outcome Measures
Hamilton rating scale for depression (HRSD)
Secondary Outcome Measures
Beck Depression Inventory (BDI)
Outcome Questionnaire (OQ)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02728557
Brief Title
Supportive and Supportive-Expressive Treatment for Depression
Acronym
SSETD
Official Title
The Roles of the Therapeutic Alliance in Understanding the Effects of Attachment Orientations on Outcome in Psychotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2016 (undefined)
Primary Completion Date
February 17, 2021 (Actual)
Study Completion Date
February 17, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Haifa
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Therapeutic alliance, Psychotherapy, Psychodynamic psychotherapy, supportive-expressive treatment, Process research, Attachment theory, Attachment orientation, Mechanism of change in psychotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supportive psychotherapy
Arm Type
Experimental
Arm Description
Participants will receive supportive therapy.
Arm Title
Supportive-expressive psychotherapy
Arm Type
Experimental
Arm Description
Participants will receive supportive-expressive therapy.
Intervention Type
Behavioral
Intervention Name(s)
Supportive-Expressive Therapy
Intervention Description
Supportive-expressive psychotherapy for depressive disorder for 16 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Supportive Therapy
Intervention Description
Supportive psychotherapy for depressive disorder for 16 weeks.
Primary Outcome Measure Information:
Title
Hamilton rating scale for depression (HRSD)
Time Frame
Change from baseline to week 16.
Secondary Outcome Measure Information:
Title
Beck Depression Inventory (BDI)
Time Frame
Measured at baseline, every week for 16 weeks of treatment, then once a month for four months and follow up after a year.
Title
Outcome Questionnaire (OQ)
Time Frame
Measured at baseline, every week for 16 weeks of treatment, then once a month for four months and follow up after a year.
Other Pre-specified Outcome Measures:
Title
Inventory of Interpersonal Problems Circumplex (IIP-C)
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.
Title
Experiences in Close Relationships Questionnaire (ECR)
Description
The measurement data will be aggregated into two sub-scales: anxiety and avoidance.
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
Title
Quality of Life Enjoyment and Satisfaction- Short Version (Q-LES-Q)
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigal Zilcha Mano
Organizational Affiliation
University of Haifa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Haifa
City
Haifa
State/Province
Mount Carmel
ZIP/Postal Code
31905
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
14399272
Citation
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.
Results Reference
background
PubMed Identifier
8290681
Citation
Endicott J, Nee J, Harrison W, Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321-6.
Results Reference
background
PubMed Identifier
3204198
Citation
Horowitz 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.
Results Reference
background
PubMed Identifier
35925745
Citation
Zilcha-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.
Results Reference
derived
PubMed Identifier
34180691
Citation
Zilcha-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.
Results Reference
derived
PubMed Identifier
30419875
Citation
Zilcha-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.
Results Reference
derived
Learn more about this trial
Supportive and Supportive-Expressive Treatment for Depression
We'll reach out to this number within 24 hrs