Clinical trial NCT02291068: Psychological Flexibility and Effectiveness of Psychotherapy
Official title: Psychological Flexibility and Effectiveness of Psychotherapy Treatment in Patients With Adjustment Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adjustment Disorder
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-11-14
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Effectiveness of psychotherapy treatment will be measured by the SCID-IV, CGS and CGI measures by the therapists
timeFrame: end of the psychotherapy treatment- an expected average of 3 months after starting therapy
Secondary outcomes:
measure: Well being will be measured by the Mental Health Inventory (MHI: Veit and Ware 1983)
timeFrame: Baseline and at the end of the psychotherapy treatment-an expected average of 3 months after starting therapy
measure: Therapeutic Alliance will be measured by the The Working Alliance Inventory-Short Revised (WAI-SR) (Munder et al., 2010)
timeFrame: end of the psychotherapy treatment- an expected average of 3 months after starting therapy
measure: Psychological Flexibility will be measured by the Psychological Flexibility Questionnaire (PFQ) (Ben-Itzhak et al., 2014).
timeFrame: Baseline and at the end of the psychotherapy treatment-an expected average of 3 months after starting therapy
Other outcomes:
Locations:
Study officials:
affiliation: shulamitb@tlvmc.gov.il
name: Shulamit Ben Itzhak, Dr
role: PRINCIPAL_INVESTIGATOR
References: