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Supportive and Supportive-Expressive Treatment for Depression (SSETD)

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ClinicalTrials.gov Identifier: NCT02728557
Recruitment Status : Active, not recruiting
First Posted : April 5, 2016
Last Update Posted : December 31, 2020
Sponsor:
Information provided by (Responsible Party):
Sigal Zilcha Mano, University of Haifa

Study Description
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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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Supportive-Expressive Therapy Behavioral: Supportive Therapy Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Roles of the Therapeutic Alliance in Understanding the Effects of Attachment Orientations on Outcome in Psychotherapy
Study Start Date : March 2016
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Supportive psychotherapy
Participants will receive supportive therapy.
 Behavioral: Supportive Therapy
Supportive psychotherapy for depressive disorder for 16 weeks.
Experimental: Supportive-expressive psychotherapy
Participants will receive supportive-expressive therapy.
 Behavioral: Supportive-Expressive Therapy
Supportive-expressive psychotherapy for depressive disorder for 16 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Hamilton rating scale for depression (HRSD) [ Time Frame: Change from baseline to week 16. ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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 Outcome Measures:
  1. 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. ]
  2. Experiences in Close Relationships Questionnaire (ECR) [ 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 ]
    The measurement data will be aggregated into two sub-scales: anxiety and avoidance.

  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728557


Locations
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Israel
University of Haifa
Haifa, Mount Carmel, Israel, 31905
Sponsors and Collaborators
University of Haifa
Investigators
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Principal Investigator: Sigal Zilcha Mano University of Haifa
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sigal Zilcha Mano, Senior Lecturer, University of Haifa
ClinicalTrials.gov Identifier: NCT02728557    
Other Study ID Numbers: ISF 186.15
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: December 31, 2020
Last Verified: December 2020
Keywords provided by Sigal Zilcha Mano, University of Haifa:
Therapeutic alliance
Psychotherapy
Psychodynamic psychotherapy
supportive-expressive treatment
 Process research
Attachment theory
Attachment orientation
Mechanism of change in psychotherapy
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders