Adjustment DisorderNCT02291068
Psychological Flexibility and Effectiveness of Psychotherapy
A study testing psychotherapy treatment in people with Adjustment Disorder, run by Tel-Aviv Sourasky Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Adjustment Disorder
- What is being tested?
- psychotherapy treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Patients with major depression, a psychotic disorder, alcohol or drug dependence will be excluded.
Trial locations and contacts
No sites are listed yet.
Shulamit Ben Itzhak, Dr contact
Neta Amit contact
About this study
Official title: Psychological Flexibility and Effectiveness of Psychotherapy Treatment in Patients With Adjustment Disorder
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.
Read the 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.
- Conditions
- Adjustment Disorder
- Being tested
- psychotherapy treatment
- Medical subject headings
- Adjustment Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychotherapy treatmentBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| psychotherapy treatment | Other | 3 months long (12 sessions) dynamic psychotherapy. Receives: Behavioral: psychotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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).
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.
Measured: Baseline and at the end of the psychotherapy treatment-an expected average of 3 months after starting therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adjustment DisorderStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shulamit Ben Itzhak, Dr, Principal investigator, shulamitb@tlvmc.gov.il
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291068
- Sponsor's protocol ID
- TelAvivSMO
- Status last verified
- Nov 2014
- First submitted
- 20 Oct 2014
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Flexibility and Effectiveness of Psychotherapy Treatment in Patients With Adjustment Disorder
- ClinicalTrials.gov ID
- NCT02291068
- Acronym / sponsor ID
- TelAvivSMO
- Conditions
- Adjustment Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| psychotherapy treatment | Other | Behavioral: psychotherapy treatment3 months long (12 sessions) dynamic psychotherapy. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients with major depression, a psychotic disorder, alcohol or drug dependence will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychotherapy treatment3 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). | Behavioural | psychotherapy treatment |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shulamit Ben Itzhak, Dr contact
Neta Amit contact
Shulamit Ben Itzhak, Dr principal investigator
shulamitb@tlvmc.gov.il
Questions about this trial
What is this clinical trial studying?
A study testing psychotherapy treatment in people with Adjustment Disorder, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shulamit Ben Itzhak, Dr (shulamitb@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2014.