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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

Tracking Information
First Submitted Date  ICMJE March 15, 2016
First Posted Date  ICMJE April 5, 2016
Last Update Posted Date December 31, 2020
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2016)
Hamilton rating scale for depression (HRSD) [ Time Frame: Change from baseline to week 16. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2016)
  • 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. ]
  • 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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 30, 2016)
  • 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. ]
  • 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.
  • 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 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Supportive and Supportive-Expressive Treatment for Depression
Official Title  ICMJE The Roles of the Therapeutic Alliance in Understanding the Effects of Attachment Orientations on Outcome 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Behavioral: Supportive-Expressive Therapy
    Supportive-expressive psychotherapy for depressive disorder for 16 weeks.
  • Behavioral: Supportive Therapy
    Supportive psychotherapy for depressive disorder for 16 weeks.
Study Arms  ICMJE
  • Experimental: Supportive psychotherapy
    Participants will receive supportive therapy.
    Intervention: Behavioral: Supportive Therapy
  • Experimental: Supportive-expressive psychotherapy
    Participants will receive supportive-expressive therapy.
    Intervention: Behavioral: Supportive-Expressive Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 30, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02728557
Other Study ID Numbers  ICMJE ISF 186.15
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sigal Zilcha Mano, University of Haifa
Study Sponsor  ICMJE University of Haifa
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sigal Zilcha Mano University of Haifa
PRS Account University of Haifa
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP