Supportive and Supportive-Expressive Treatment for Depression (SSETD)

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

Tracking Information

• First Submitted Date: March 15, 2016
• First Posted Date: April 5, 2016
• Last Update Posted Date: December 31, 2020
• Study Start Date: March 2016
• Estimated Primary Completion Date: February 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 30, 2016): Hamilton rating scale for depression (HRSD) [ Time Frame: Change from baseline to week 16. ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: 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: Supportive and Supportive-Expressive Treatment for Depression
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Major Depressive Disorder

Intervention

• 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

• 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 *

• HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23:56-62.
• 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.
• Horowitz LM, Rosenberg SE, Baer BA, Ureño G, Villaseñor VS. Inventory of interpersonal problems: psychometric properties and clinical applications. J Consult Clin Psychol. 1988 Dec;56(6):885-92.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: March 30, 2016): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2021
• Estimated Primary Completion Date: February 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT02728557
• Other Study ID Numbers: ISF 186.15
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Sigal Zilcha Mano, University of Haifa
• Study Sponsor: University of Haifa
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sigal Zilcha Mano; University of Haifa

• PRS Account: University of Haifa
• Verification Date: December 2020