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Completed

NCT Number: NCT02728557

Supportive and Supportive-Expressive Treatment for Depression

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Haifa

Haifa, Mount Carmel, 31905, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supportive-Expressive Therapy

Behavioral

Supportive-expressive psychotherapy for depressive disorder for 16 weeks.

Supportive Therapy

Behavioral

Supportive psychotherapy for depressive disorder for 16 weeks.

Primary outcomes

  1. Hamilton Rating Scale for Depression (HRSD)

    Time frame: 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 outcomes

  1. Beck Depression Inventory (BDI)

    Time frame: 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

  2. Outcome Questionnaire (OQ)

    Time frame: 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

Other outcomes

  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; reports refer to baseline and changes from baseline to week 16

    Inventory of Interpersonal Problems Circumplex; measuring interpersonal problems; higher means worse outcomes Inventory of Interpersonal Problems-Circumplex (IIP-C). The IIP-C is a 32-item self-report questionnaire assessing interpersonal difficulties and distress.

    Patients rate two types of items: interpersonal behaviors that are "hard for you to do" (e.g., "it is hard for me to let other people know when I am angry") and interpersonal behaviors that "you do too much" (e.g., "I am too afraid of other people").

    Ratings of the degree to which each problem is distressing are made on a 5-point scale, ranging from 0 (not at all) to 4 (extremely).

    Calculated as a sum score. Range 0 -128

  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; reports refer to baseline and changes from baseline to week 16

    Experiences in Close Relationships Questionnaire; The measurement data will be aggregated into two sub-scales: anxiety and avoidance; higher scores mean worse outcomes (less secure attachment) Experience in Close Relationships Scale (ECR; Brennan et al., 1998). 36-item self-reported measure. Participants rated the extent to which each item was descriptive of their experiences in close relationships on a 7-point Likert scale ranging from 1 (not at all) to 7 (very much).

    18 items assessed attachment anxiety (e.g., "I worry about being abandoned"). 18 assessed attachment avoidance (e.g., "I prefer not to show a partner how I feel deep down"). The reliability and validity of these scales have been repeatedly demonstrated (Brennan et al., 1998; Mikulincer & Shaver, 2007).

    The score for each subscale is calculated as the average value Range 1-7

  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; reports refer to baseline and change from baseline to week 16

    Quality of Life Enjoyment and Satisfaction- Short Version; measuring quality of life; higher scores mean better outcomes.

    The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). It's a self-report measure, meaning the person being assessed completes the questionnaire themselves.

    Purpose: It gauges the degree of enjoyment and satisfaction a person experiences in different areas of their daily functioning.

    Utilize a 5-point Likert scale, ranging from 1 (very poor) to 5 (very good). Higher scores mean better outcomes. Range 1-5. Average score

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Registry information

Official study title

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

Acronym: SSETD

Important dates

Study start
2016
Primary completion
2021
Study completion
2023
First posted
Apr 5, 2016
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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