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
About this trial
This is an interventional treatment trial for Adjustment Disorder
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.
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
NCT ID
NCT02291068
First Posted
October 20, 2014
Last Updated
November 11, 2014
Sponsor
Tel-Aviv Sourasky Medical Center
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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