Supportive and Supportive-Expressive Treatment for Depression

NCT02728557 | Completed Results DMC

• 1 other identifier: ISF 186.15
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Therapeutic alliance; Psychotherapy; Psychodynamic psychotherapy; supportive-expressive treatment; Process research; Attachment theory; Attachment orientation; Mechanism of change in psychotherapy

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale for Depression (HRSD)

  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

  Slope from baseline to week 16.

Secondary Outcomes (2)

• 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

• 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

Other Outcomes (3)

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

• Experiences in Close Relationships Questionnaire (ECR)

  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

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

Study Arms (2)

Supportive psychotherapy

EXPERIMENTAL

Participants will receive supportive therapy.

Behavioral: Supportive Therapy

Supportive-expressive psychotherapy

EXPERIMENTAL

Participants will receive supportive-expressive therapy.

Behavioral: Supportive-Expressive Therapy

Interventions

Supportive-Expressive Therapy BEHAVIORAL

Supportive-expressive psychotherapy for depressive disorder for 16 weeks.

Supportive-expressive psychotherapy

Supportive Therapy BEHAVIORAL

Supportive psychotherapy for depressive disorder for 16 weeks.

Supportive psychotherapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Haifa: lead

Study Sites (1)

University of Haifa

Haifa, Mount Carmel, 31905, Israel

Location

Related Publications (7)

• HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.

  PMID: 14399272 BACKGROUND

• 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.

  PMID: 8290681 BACKGROUND

• Horowitz LM, Rosenberg SE, Baer BA, Ureno G, Villasenor VS. Inventory of interpersonal problems: psychometric properties and clinical applications. J Consult Clin Psychol. 1988 Dec;56(6):885-92. doi: 10.1037//0022-006x.56.6.885. No abstract available.

  PMID: 3204198 BACKGROUND

• Zilcha-Mano S, Webb CA. Identifying who benefits most from supportive versus expressive techniques in psychotherapy for depression: Moderators of within- versus between-individual effects. J Consult Clin Psychol. 2024 Mar;92(3):187-197. doi: 10.1037/ccp0000868. Epub 2023 Dec 7.

  PMID: 38059944 DERIVED

• Zilcha-Mano S, Ben David-Sela T. Is alliance therapeutic in itself? It depends. J Couns Psychol. 2022 Nov;69(6):786-793. doi: 10.1037/cou0000627. Epub 2022 Aug 4.

  PMID: 35925745 DERIVED

• Zilcha-Mano S, Dolev-Amit T, Fisher H, Ein-Dor T, Strauss B. Patients' individual differences in implicit and explicit expectations from the therapist as a function of attachment orientation. J Couns Psychol. 2021 Nov;68(6):682-695. doi: 10.1037/cou0000503. Epub 2021 Jun 28.

  PMID: 34180691 DERIVED

• Zilcha-Mano S, Dolev T, Leibovich L, Barber JP. Identifying the most suitable treatment for depression based on patients' attachment: study protocol for a randomized controlled trial of supportive-expressive vs. supportive treatments. BMC Psychiatry. 2018 Nov 12;18(1):362. doi: 10.1186/s12888-018-1934-1.

  PMID: 30419875 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

Because of COVID, 13 patients were treated remotely. The total number of patients was according to the pre-registration.

Results Point of Contact

• Title: Prof. Sigal Zilcha-Mano
• Organization: University of Haifa

sigalzil@gmail.com

972-4-8249047

Study Officials

• Sigal Zilcha Mano

  University of Haifa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: April 5, 2016
• Study Start: March 2, 2016
• Primary Completion: February 17, 2021
• Study Completion: October 17, 2023
• Last Updated: January 27, 2025
• Results First Posted: January 27, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)