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Psychological Flexibility and Effectiveness of Psychotherapy

Primary Purpose

Adjustment Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
psychotherapy treatment
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adjustment Disorder

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adjustment disorder as the referral cause, age ranging from 20 to 65 years old and Hebrew speaking. The diagnosis of adjustment disorder will be confirmed by an open clinical interview followed by a Structured Clinical Interview for DSM-IV SCID-IV (Shalev et al. 1994; First et al. 1995).

Exclusion Criteria:

Patients with major depression, a psychotic disorder, alcohol or drug dependence will be excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    psychotherapy treatment

    Arm Description

    3 months long (12 sessions) dynamic psychotherapy.

    Outcomes

    Primary Outcome Measures

    Effectiveness of psychotherapy treatment will be measured by the SCID-IV, CGS and CGI measures by the therapists
    Psychotherapy outcomes will be evaluated by the patients and therapists, using a number of measures. First, the therapists would use the SCID-IV, as they did at the beginning of the treatment. Second, they would fill out a CGS and CGI questionnaires.

    Secondary Outcome Measures

    Well being will be measured by the Mental Health Inventory (MHI: Veit and Ware 1983)
    The Mental Health Inventory (MHI: Veit and Ware 1983), a self-report questionnaire which measures psychological distress and well-being, psychiatric symptoms, and clinician rating of illness severity, will be used to measure psychological distress and well-being in the past month.
    Therapeutic Alliance will be measured by the The Working Alliance Inventory-Short Revised (WAI-SR) (Munder et al., 2010)
    The Working Alliance Inventory-Short Revised (WAI-SR) (Munder, Wilmers, Leonhart, Linster, & Barth, 2010) is a measure of the therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. It is a self-report questionnaire, which includes 12 items on 1-5 scale. A high score indicates a better therapeutic alliance. The questionnaire was translated to Hebrew and back-translated by the researchers of the current research.
    Psychological Flexibility will be measured by the Psychological Flexibility Questionnaire (PFQ) (Ben-Itzhak et al., 2014).
    Psychological Flexibility Questionnaire (PFQ) (Ben-Itzhak, Bluvstein, & Maor, 2014), which includes 20 items 20, divided to 5 factors, each relating to a significant domain of psychological flexibility: (1) positive perception of change; (2) characterization of the self as flexible; (3) self-characterization as open and innovative; (4) a perception of reality as dynamic and changing, and (5), a perception of reality as multifaceted.

    Full Information

    First Posted
    October 20, 2014
    Last Updated
    November 11, 2014
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02291068
    Brief Title
    Psychological Flexibility and Effectiveness of Psychotherapy
    Official Title
    Psychological Flexibility and Effectiveness of Psychotherapy Treatment in Patients With Adjustment Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    November 2015 (Anticipated)
    Study Completion Date
    November 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The Objectives of the current research is to evaluate whether psychological flexibility influences psychotherapy outcomes in patients with adjustment disorder and depression. If indeed this is the case, we would be able to identify risk factors for low adjustment- such as low psychological flexibility, and develop psychotherapy that would try to enhance this ability.
    Detailed Description
    Subjects will be recruited from the Psychiatric daycare center at the Tel-Aviv Souraski Medical Center, serving the broader Tel-Aviv municipal area. Referrals to the department will be screened for eligibility to participate in the study according to the study's inclusion and exclusion criteria. Inclusion criteria would be adjustment disorder as the referral cause, age ranging from 20 to 65 years old and Hebrew speaking. Patients with major depression, a psychotic disorder, alcohol or drug dependence will be excluded. All participants will sign a written informed consent. The diagnosis of adjustment disorder will be confirmed by an open clinical interview followed by a Structured Clinical Interview for DSM-IV SCID-IV (Shalev et al. 1994; First et al. 1995). Before starting the psychotherapy treatment, the patients will fill a psychological flexibility questionnaire (PFQ) and well-being questionnaire (MHI), in order to evaluate their psychological flexibility and well-being baseline. At the end of the psychotherapy treatment, they will fill the questionnaires again. Also, their therapists will evaluate the patients' levels of adjustment disorder or depression before and after the therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adjustment Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    psychotherapy treatment
    Arm Type
    Other
    Arm Description
    3 months long (12 sessions) dynamic psychotherapy.
    Intervention Type
    Behavioral
    Intervention Name(s)
    psychotherapy treatment
    Intervention Description
    3 months long (12 sessions) dynamic psychotherapy. The dynamic psychotherapeutic technique which will be applied in the current research is derived from Malan's focused, brief psychodynamic psychotherapy (Malan 1976) and from the literature specifying psychodynamic psychotherapies distinctive techniques (Shedler 2010). The principle of this treatment is a time limited intervention in which the primary objective is to enhance the patient's insights regarding repetitive conflicts. As psychodynamic psychotherapy is suitable for all kinds of adjustment disorders, no special adjustment in the course of therapy was made for the different subtypes (Cabaniss et al. 2011).
    Primary Outcome Measure Information:
    Title
    Effectiveness of psychotherapy treatment will be measured by the SCID-IV, CGS and CGI measures by the therapists
    Description
    Psychotherapy outcomes will be evaluated by the patients and therapists, using a number of measures. First, the therapists would use the SCID-IV, as they did at the beginning of the treatment. Second, they would fill out a CGS and CGI questionnaires.
    Time Frame
    end of the psychotherapy treatment- an expected average of 3 months after starting therapy
    Secondary Outcome Measure Information:
    Title
    Well being will be measured by the Mental Health Inventory (MHI: Veit and Ware 1983)
    Description
    The Mental Health Inventory (MHI: Veit and Ware 1983), a self-report questionnaire which measures psychological distress and well-being, psychiatric symptoms, and clinician rating of illness severity, will be used to measure psychological distress and well-being in the past month.
    Time Frame
    Baseline and at the end of the psychotherapy treatment-an expected average of 3 months after starting therapy
    Title
    Therapeutic Alliance will be measured by the The Working Alliance Inventory-Short Revised (WAI-SR) (Munder et al., 2010)
    Description
    The Working Alliance Inventory-Short Revised (WAI-SR) (Munder, Wilmers, Leonhart, Linster, & Barth, 2010) is a measure of the therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. It is a self-report questionnaire, which includes 12 items on 1-5 scale. A high score indicates a better therapeutic alliance. The questionnaire was translated to Hebrew and back-translated by the researchers of the current research.
    Time Frame
    end of the psychotherapy treatment- an expected average of 3 months after starting therapy
    Title
    Psychological Flexibility will be measured by the Psychological Flexibility Questionnaire (PFQ) (Ben-Itzhak et al., 2014).
    Description
    Psychological Flexibility Questionnaire (PFQ) (Ben-Itzhak, Bluvstein, & Maor, 2014), which includes 20 items 20, divided to 5 factors, each relating to a significant domain of psychological flexibility: (1) positive perception of change; (2) characterization of the self as flexible; (3) self-characterization as open and innovative; (4) a perception of reality as dynamic and changing, and (5), a perception of reality as multifaceted.
    Time Frame
    Baseline and at the end of the psychotherapy treatment-an expected average of 3 months after starting therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adjustment disorder as the referral cause, age ranging from 20 to 65 years old and Hebrew speaking. The diagnosis of adjustment disorder will be confirmed by an open clinical interview followed by a Structured Clinical Interview for DSM-IV SCID-IV (Shalev et al. 1994; First et al. 1995). Exclusion Criteria: Patients with major depression, a psychotic disorder, alcohol or drug dependence will be excluded.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shulamit Ben Itzhak, Dr
    Email
    shulamitb@tlvmc.gov.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Neta Amit
    Email
    netaamit86@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shulamit Ben Itzhak, Dr
    Organizational Affiliation
    shulamitb@tlvmc.gov.il
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Psychological Flexibility and Effectiveness of Psychotherapy

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