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Psychological Flexibility and Effectiveness of Psychotherapy

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ClinicalTrials.gov Identifier: NCT02291068
Recruitment Status : Unknown
Verified November 2014 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 14, 2014
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

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.

Condition or disease Intervention/treatment Phase
Adjustment Disorder Behavioral: psychotherapy treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychological Flexibility and Effectiveness of Psychotherapy Treatment in Patients With Adjustment Disorder
Study Start Date : November 2014
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2015

Arm Intervention/treatment
psychotherapy treatment
3 months long (12 sessions) dynamic psychotherapy.
Behavioral: psychotherapy treatment
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 Measures :
  1. Effectiveness of psychotherapy treatment will be measured by the SCID-IV, CGS and CGI measures by the therapists [ Time Frame: end of the psychotherapy treatment- an expected average of 3 months after starting therapy ]
    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 :
  1. Well being will be measured by the Mental Health Inventory (MHI: Veit and Ware 1983) [ Time Frame: Baseline and at the end of the psychotherapy treatment-an expected average of 3 months after starting therapy ]
    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.

  2. Therapeutic Alliance will be measured by the The Working Alliance Inventory-Short Revised (WAI-SR) (Munder et al., 2010) [ Time Frame: end of the psychotherapy treatment- an expected average of 3 months after starting therapy ]
    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.

  3. Psychological Flexibility will be measured by the Psychological Flexibility Questionnaire (PFQ) (Ben-Itzhak et al., 2014). [ Time Frame: Baseline and at the end of the psychotherapy treatment-an expected average of 3 months after starting therapy ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291068


Contacts
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Contact: Shulamit Ben Itzhak, Dr shulamitb@tlvmc.gov.il
Contact: Neta Amit netaamit86@gmail.com

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Shulamit Ben Itzhak, Dr shulamitb@tlvmc.gov.il
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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02291068    
Other Study ID Numbers: TelAvivSMO
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Adjustment Disorders
Trauma and Stressor Related Disorders
Mental Disorders