NCT02291068

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 14, 2014

Status Verified

November 1, 2014

Enrollment Period

1 year

First QC Date

October 20, 2014

Last Update Submit

November 11, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    end of the psychotherapy treatment- an expected average of 3 months after starting therapy

Secondary Outcomes (3)

  • Well being will be measured by the Mental Health Inventory (MHI: Veit and Ware 1983)

    Baseline and at the end of the psychotherapy treatment-an expected average of 3 months after starting therapy

  • Therapeutic Alliance will be measured by the The Working Alliance Inventory-Short Revised (WAI-SR) (Munder et al., 2010)

    end of the psychotherapy treatment- an expected average of 3 months after starting therapy

  • Psychological Flexibility will be measured by the Psychological Flexibility Questionnaire (PFQ) (Ben-Itzhak et al., 2014).

    Baseline and at the end of the psychotherapy treatment-an expected average of 3 months after starting therapy

Study Arms (1)

psychotherapy treatment

OTHER

3 months long (12 sessions) dynamic psychotherapy.

Behavioral: psychotherapy treatment

Interventions

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).

psychotherapy treatment

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Adjustment Disorders

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental Disorders

Study Officials

  • Shulamit Ben Itzhak, Dr

    shulamitb@tlvmc.gov.il

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shulamit Ben Itzhak, Dr

CONTACT

Neta Amit

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2014

First Posted

November 14, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 14, 2014

Record last verified: 2014-11