Supportive-Expressive and Emotion-Focused Treatment for Depression

Official title

Investigating Mechanisms of Change in Supportive-Expressive vs. Emotion-Focused Treatment of Depression Using a Personalized Treatment Approach: The Case of the Theories of Weakness vs. Strength

Overview

This study will explore the mechanisms of change that are activated when individuals receive a treatment that targets their weakness and the mechanisms activated when the treatment capitalize on their strength. Patients will be assigned to one of two types of psychotherapies in treating people with a major depression disorder, expressive-supportive vs. emotion-focused treatment. Their ability to benefit from treatment based on their pre-treatment levels of insight and emotional processing will be examined. This is a four-month protocol, with a 2 year follow up period.

Detailed description

One hundred and twenty-four patients suffering from major depressive disorder will be randomized to participate in 16 sessions of either supportive-expressive therapy or emotion-focused therapy. The two treatments are theorized to differ in their main mechanism of change: supportive-expressive therapy places emphasis on insight as its main mechanism of change, and emotion-focused therapy places emphasis on emotional processing as its main mechanism of change. Both can serve as strength- or weakness-focused treatments, based on the patient's baseline levels of insight and emotional processing. Importantly, this study will employ multiple complementary methods, which will include session-by-session self-report questionnaires from both patient and therapist, as well as interdisciplinary measures based on hormonal and acoustic measures, cognitive tasks, clinician interviews, and behavioral coding systems to complement the self-report measures. In addition, prior the beginning of treatment patients will complete diaries via mobile survey application. The findings will contribute to the research on personalized mechanisms of change and can help clinicians focus on more efficient treatment delivery, adapted to given subpopulations of patients, according to their strengths and weaknesses. If a mechanism most likely to stimulate change for a subpopulation is identified, a corresponding treatment can be chosen that is most likely to activate that particular mechanism and by that improve the rate of patients' respondent to treatment.

Interventions

• Behavioral Supportive-expressive treatment
  Sixteen weeks of a time-limited psychodynamic therapy adapted for depression that includes the use of expressive techniques, such as interpretation, confrontation, clarification and the use of supportive techniques, such as affirmation and empathic validation. This treatment postulates insight as its core mechanism of change.
• Behavioral Emotions-Focused treatment
  Sixteen weeks of a brief experiential therapy for depression that combine client-centered relational elements (unconditional positive regard, congruence, and empathy) with marker-guided experiential interventions designed to facilitate and deepen emotional processing and emotion regulation.

Primary outcome measures

• Weekly change in Hamilton rating scale for depression (HRSD) [Time frame: up to 16 weeks.]

Secondary outcome measures (4)

• Weekly change in Beck Depression Inventory (BDI) [Time frame: up to 16 weeks]
• Weekly change in Outcome Questionnaire (OQ) [Time frame: up to 16 weeks]
• Trajectories of change in Inventory of Interpersonal Problems (IIP-32) [Time frame: At intake and 6 times during the treatment (weeks 1, 2, 4, 8, 12, 16)]
• trajectories of change in Quality of Life Enjoyment and Satisfaction- Short Version (Q-LES-Q) [Time frame: At intake and 6 times during the treatment (weeks 1, 2, 4, 8, 12, 16)]

Eligibility criteria

Inclusion criteria

• Meeting major depressive disorder diagnostic criteria using the structured clinical interviews for Diagnostic and Statistical Manual of Mental Disorders-5 and scoring more than 14 on the 17-item Hamilton rating scale for depression at two evaluations (one week apart) (Hamilton, 1967).
• 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 65
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Israel · 1 center

• University of Haifa — Haifa

Publications

• Zilcha-Mano S, Shahar B, Fisher H, Dolev-Amit T, Greenberg LS, Barber JP. Investigating patient-specific mechanisms of change in SET vs. EFT for depression: study protocol for a mechanistic randomized controlled trial. BMC Psychiatry. 2021 Jun 2;21(1):287. doi: 10.1186/s12888-021-03279-y. PMID 34078324

Identifiers

NCT: NCT04576182 · ISF 395/19

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗