Supportive and Supportive-Expressive Treatment for Depression

Major Depressive Disorder Clinical Trial

— SSETD  

Official title:

The Roles of the Therapeutic Alliance in Understanding the Effects of Attachment Orientations on Outcome in Psychotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02728557
• Other study ID #: ISF 186.15
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2016
• Est. completion date: February 17, 2023

Study information

• Verified date: February 2022
• Source: University of Haifa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: February 17, 2023
• Est. primary completion date: February 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• Supportive-Expressive Therapy
Supportive-expressive psychotherapy for depressive disorder for 16 weeks.
• Supportive Therapy
Supportive psychotherapy for depressive disorder for 16 weeks.

Locations

Country	Name	City	State
Israel	University of Haifa	Haifa	Mount Carmel

Sponsors (1)

Lead Sponsor	Collaborator
University of Haifa

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View Citation

HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23:56-62. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Inventory of Interpersonal Problems Circumplex (IIP-C)		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.
Other	Experiences in Close Relationships Questionnaire (ECR)	The measurement data will be aggregated into two sub-scales: anxiety and avoidance.	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
Other	Quality of Life Enjoyment and Satisfaction- Short Version (Q-LES-Q)		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
Primary	Hamilton rating scale for depression (HRSD)		Change from baseline to week 16.
Secondary	Beck Depression Inventory (BDI)		Measured at baseline, every week for 16 weeks of treatment, then once a month for four months and follow up after a year.
Secondary	Outcome Questionnaire (OQ)		Measured at baseline, every week for 16 weeks of treatment, then once a month for four months and follow up after a year.