Supportive and Supportive-Expressive Treatment for Depression

Not Applicable

Completed

Conditions: Major Depressive Disorder

Interventions: Behavioral: Supportive Therapy
Behavioral: Supportive-Expressive Therapy

Registration Number: NCT02728557

Lead Sponsor: University of Haifa

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supportive psychotherapy	Supportive Therapy	Participants will receive supportive therapy.
Supportive-expressive psychotherapy	Supportive-Expressive Therapy	Participants will receive supportive-expressive therapy.

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression (HRSD)	Slope from baseline to week 16.	A clinically administered measure assessing the severity of depression. The Hamilton is the standard measure of depression severity for clinical trials. The scoring is based on the first 17-items of the Hamilton. 0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression \>=23 = Very Severe Depression Hamilton Rating Scale for Depression, developed by Max Hamilton in 1967, is a widely used tool for assessing the severity of depression in adults. 17 items covering various aspects of depression experienced in the past week. Each item is rated on a 3-point or 5-point scale depending on the specific symptom. Total score (sum score) provides an indication of depression severity. The range is 0-52

Secondary Outcome Measures

Name	Time	Method
Beck Depression Inventory (BDI)	Slope from baseline to week 16. Measured at baseline, every week for 16 weeks of treatment, then once a month for four months and follow up after a year; Scores are provided for baseline and change from baseline to week 16	Beck Depression Inventory; measuring depression by a self-report measure; higher means worse outcomes. The Beck Depression Inventory consists of 21 multiple-choice questions. Each question presents different statements reflecting varying intensities of a particular depressive symptom. Each question has scores ranging from 0 (no symptoms) to 3 (most severe symptoms). The total score is obtained by summing up the scores of all chosen responses. Based on the total score, there are different interpretations of depression severity: Scores in the 0-13 range suggest minimal or no depression. Scores between 14-19 indicate mild depression. Scores from 20-28 reflect moderate depression. Scores 29 and above suggest severe depression. Range 0-63
Outcome Questionnaire (OQ)	Slope from baseline to week 16. Measured at baseline, every week for 16 weeks of treatment, then once a month for four months and follow up after a year; Scores are provided for baseline and change from baseline to week 16	Outcome Questionnaire; measuring Symptom Distress, Interpersonal Relationships, Social Role; higher levels mean worse outcome. Outcome Questionnaire-30 (OQ-30; Lambert et al., 1996). OQ-30 is a 30-item self-report measure assessing distress, designed to measure patient progress. Items were rated on a 5 point likert scale ranging from 0 (never) to 4 (almost always). The OQ-30 has three subscales assessing symptom distress, interpersonal relations, and social role performance. A total score is calculated by sum scores. Range 0-120