Psychotherapy Expectations and Distress Among Mental Health Patients and Their Therapists.

April 29, 2025 updated by: Yuval Bloch, Shalvata Mental Health Center

The Associations Between Psychotherapy Expectations and Distress Among Adults Hospitalized in Psychiatric Departments or Treated in the Ambulatory/Community Clinics and Their Therapists.

Patients will be recruited from the units of Shalvata MHC: closed and open hospitalization unit, and ambulatory units of Shalvata MHC community clinic. Their therapists will be recruited as well. There will be 4 timepoints measurement: baseline, second week, fourth week and after eight weeks (or discharge). Patients will be addressed through the therapeutic staff and the research team will contact them after a conceptually agreement to participate. A member of the research staff will schedule a meeting explaining the research thoroughly and ask the patient/therapist to sign an informed consent. After signing an informed consent, patients will complete several questionnaires at several time points, whereas their therapists will complete measures as well. All scales will be filled using the Qualtrics platform. In hospitalization unit questionnaires will be filled with the aid of the research coordinator, and in the facilities of Shalvata MHC, in face-to-face interaction. During the face-to-face interaction, in case the patient will report suicidal thoughts or plan to a member of the research staff, the therapeutic staff will be notified immediately. patients at community clinics will fill the first measurement in face-to-face interaction and the rest of the questionnaires independently recieveg a link to their mobile phone.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Israel
      • Israel, Israel
        • Recruiting
        • Shalvata Mental Health Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Sample will be comprised of adults hospitalized in psychiatric departments or treated in the ambulatory/community clinics of Shalvata MHC and their therapists.

Description

Inclusion Criteria:

  • Hebrew mother tongue speakers
  • Being treated at Shalvata MHC.

Exclusion Criteria:

  • Inability to read or comprehend Hebrew due to any reason.
  • Agitative patients
  • Acute suicidal patients
  • Patients in unstable psychotic state

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients at Shalvata Mental Health Center

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Symptom Checklist (SCL-10R)
Time Frame: From enrollment, 2 weeks, 4 weeks and 8 weeks after enrolment
The scale is a shorter version of the SCL-90 , a self-report inventory consist of 90 items that measure psychosomatic and psychological symptoms for the recent week. The shorter version includes 10 items and has been used in several studies for global psychological distress. Participants are asked to rate each item on a 5-point Likert scale (0 = "no at all" to 4 = "extremely") (e.g. feeling blue). Higher score represents more psychopathology. Cronbach's alpha of the scale was 0.87. In the current study we will translate the questionnaire to Hebrew using back-translation.
From enrollment, 2 weeks, 4 weeks and 8 weeks after enrolment
The Expectations of Active Processes in Psychotherapy Scale (EAPPS)
Time Frame: At enrollment and 8 weeks after enrolment
The EAPPS is a scale designed to assess expectations about the active processes assumed to facilitates change in psychotherapy. It includes 32 items representing 7 factors: establishment of positive therapist-client relations, verbal processing of therapist-client relations, exploration of unexpressed contents, the ability to share sensitive contents openly and secretly, working through specific emotional problems, therapy fosters resilience and therapy provides tools for cognitive control. Each respondent will be asked to rate their level of agreement with each item as a mechanism therapy work through on a 7-point Likert scale ranging from 1 (Not at all) to 7 (To a large extent). The score for each factor is calculated by the sum of its items. The EAPPS have been developed in Hebrew and translated into English. Cronbach's alpha of the subscales ranged between .66-.85, and internal and external validity has been established.
At enrollment and 8 weeks after enrolment
Outcome expectations (an item from Credibility/Expectancy Questionnaire (CEQ)
Time Frame: From enrollment, 2 weeks, 4 weeks and 8 weeks after enrollment
for measuring outcome expectations we will use this 6 items scale divided to two parts. The first one addresses what the subject thinks and includes three credibility items rated on a 9-point Likert-type scale. the minimum value is 1 (not at all sure/think the therapy will be useful) and the maximum value is 9 (very useful). Also, one outcome expectancy item rated from 0 to 100% in 10 jumps (e.g. 0, 10%, 20%...).''By the end of the therapy period, how much improvement in your presenting concerns/problems do you think will occur?''. The second part includes two items rated on a 9-point Likert-type scale that addresses to what the subject feels (e.g." By the end of the therapy period, how much improvement in your presenting concerns/problems do you feel will occur?'. For reliability measure, the total scale standardized alpha was r=0.85. This measure was used in several studies for outcome expectations and was correlated with other outcome expectations measures.
From enrollment, 2 weeks, 4 weeks and 8 weeks after enrollment
The Clinical Global Impressions Scale (CGI).
Time Frame: From enrollment, 2 weeks, 4 weeks and 8 weeks after enrollment
The scale is being used for clinicians, who are not necessarily researchers, in order to track patient's progress and treatment response over time. It includes two questions: (1) CGI-Severity and (2) CGI-Improvement. The severity question is: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?". Rated on a seven-point scale from 1=normal, not at all ill, to 7=among the most extremely ill patients. The improvement question is: "Compared to the patient's condition at admission to the project [prior to medication initiation], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment." It is important to note there are guidelines for its use.
From enrollment, 2 weeks, 4 weeks and 8 weeks after enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Multitheoretical List of Therapeutic Interventions (MULTI).
Time Frame: 2 weeks and 4 weeks after enrollment
The MULTI is a 30 items questionnaire focused on interventions from eight different psychotherapy orientations (behavioral, cognitive, dialectical behavioral, interpersonal, person centered, psychodynamic, process- experiential, and common factors). Items are rated from 1(not typical at all) to 5 (extremely typical).
2 weeks and 4 weeks after enrollment
The Stanford Expectations of Treatment Scale (SETS)
Time Frame: At enrollment and 6 weeks after enrollment
assesses positive and negative treatment expectations with 3 items each on 7-point Likert-scales from 0 'Strongly Disagree׳ l' to 6 'Strongly agree'. An example item of positive treatment expectation is "This treatment will be completely effective" and an example of negative treatment expectation is "I have fears about this treatment". The scale demonstrated good reliability (above .81 for both subscales) and predicted a significant amount of outcome variance (between 12% and 18%). The scale will be translated to Hebrew using back translation. For the therapists the word "my" will be replaced by the word "my patient".
At enrollment and 6 weeks after enrollment
Existential Isolation Scale (EIS)
Time Frame: At enrollment and 8 weeks after enrollment
The EIS measures social isolation resulting from feeling like no one understands you or reacts to the world differently. The scale has 6 items in which the respondent is asked to rate on a 10-point Likert scale, ranging from 0 (strongly disagree) to 9 (strongly agree) (e.g. People do not often share my perspective). The scale test-retest reliability in the validation article was r(144) = .78.
At enrollment and 8 weeks after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shalvata Mental Health Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Haifa, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0012-22 SHA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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