Clinical trial NCT04576182: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Psychotherapy
Mechanism of change
supportive-expressive treatment
Emotion-Focused Therapy
Psychodynamic psychotherapy
Insight
emotional processing
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Israel Science Foundation
First posted: 2020-10-06
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Weekly change in Hamilton rating scale for depression (HRSD)
timeFrame: up to 16 weeks.
Secondary outcomes:
measure: Weekly change in Beck Depression Inventory (BDI)
timeFrame: up to 16 weeks
measure: Weekly change in Outcome Questionnaire (OQ)
timeFrame: up to 16 weeks
measure: Trajectories of change in Inventory of Interpersonal Problems (IIP-32)
timeFrame: At intake and 6 times during the treatment (weeks 1, 2, 4, 8, 12, 16)
measure: trajectories of change in Quality of Life Enjoyment and Satisfaction- Short Version (Q-LES-Q)
timeFrame: At intake and 6 times during the treatment (weeks 1, 2, 4, 8, 12, 16)
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: University of Haifa
Study officials:
References:
citation: 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.