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ExpectancyNCT06908343

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

An observational study of Expectancy and Distress, Psychological, run by Shalvata Mental Health Center at 1 site in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Any age
Conditions the study is for
Expectancy, Distress, Psychological
How many people
100 participants
Where
1 siteIsrael
Study dates
20 Feb 2025to 31 Dec 2025
How long will I take part?
2 Months
Phase
Observational
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dana Elberg, MA contact

+972545551887

danaelbergg@gmail.com

Israel1 site, 1 recruiting

  • Shalvata Mental Health Center

    Israel

    Dana Elberg, MA, +972545551887, danaelbergg@gmail.com

    Recruiting

Other trials in Israel

About this study

Official title: 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.

Keywords
process expectations, distress, hospitalized patients, psychotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06908343
Study groupRoleWhat they receive
Patients at Shalvata Mental Health CenterNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptom Checklist (SCL-10R)

    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.

    Measured: From enrollment, 2 weeks, 4 weeks and 8 weeks after enrolment

  2. The Expectations of Active Processes in Psychotherapy Scale (EAPPS)

    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.

    Measured: At enrollment and 8 weeks after enrolment

  3. Outcome expectations (an item from Credibility/Expectancy Questionnaire (CEQ)

    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.

    Measured: From enrollment, 2 weeks, 4 weeks and 8 weeks after enrollment

  4. The Clinical Global Impressions Scale (CGI).

    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.

    Measured: From enrollment, 2 weeks, 4 weeks and 8 weeks after enrollment

Secondary outcomes (3)

  1. The Multitheoretical List of Therapeutic Interventions (MULTI).

    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).

    Measured: 2 weeks and 4 weeks after enrollment

  2. The Stanford Expectations of Treatment Scale (SETS)

    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".

    Measured: At enrollment and 6 weeks after enrollment

  3. Existential Isolation Scale (EIS)

    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.

    Measured: At enrollment and 8 weeks after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2025
  2. Study start20 Feb 2025
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Other
Enrolment
100 participants (estimated)
Target duration
2 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06908343
Sponsor's protocol ID
0012-22 SHA
Status last verified
Apr 2025
First submitted
27 Mar 2025
Last updated
2 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Younger J, Gandhi V, Hubbard E, Mackey S. Development of the Stanford Expectations of Treatment Scale (SETS): a tool for measuring patient outcome expectancy in clinical trials. Clin Trials. 2012 Dec;9(6):767-76. doi: 10.1177/1740774512465064. Epub 2012 Nov 20.

    PubMed 23169874

  • McCarthy KS, Barber JP. The Multitheoretical List of Therapeutic Interventions (MULTI): initial report. Psychother Res. 2009 Jan;19(1):96-113. doi: 10.1080/10503300802524343.

    PubMed 19065285

  • Pinel, E. C., Long, A. E., Murdoch, E. Q., & Helm, P. (2017). A prisoner of one's own mind: Identifying and understanding existential isolation. Personality and Individual Differences, 105, 54-63.

  • Solomonov N, McCarthy KS, Gorman BS, Barber JP. The Multitheoretical List of Therapeutic Interventions - 30 items (MULTI-30). Psychother Res. 2019 Jul;29(5):565-580. doi: 10.1080/10503307.2017.1422216. Epub 2018 Jan 16.

    PubMed 29336228

  • Rosen CS, Drescher KD, Moos RH, Finney JW, Murphy RT, Gusman F. Six- and ten-item indexes of psychological distress based on the Symptom Checklist-90. Assessment. 2000 Jun;7(2):103-11. doi: 10.1177/107319110000700201.

    PubMed 10868247

  • Derogatis LR, Lipman RS, Covi L. SCL-90: an outpatient psychiatric rating scale--preliminary report. Psychopharmacol Bull. 1973 Jan;9(1):13-28. No abstract available.

    PubMed 4682398

  • Coyne AE, Constantino MJ, Boswell JF, Gaines AN, Kraus DR. Therapist-Level Moderators of Patient-Therapist Match Effectiveness in Community Psychotherapy. Adm Policy Ment Health. 2024 Sep;51(5):738-752. doi: 10.1007/s10488-024-01360-8. Epub 2024 Apr 2.

    PubMed 38565810

  • Constantino MJ, Coyne AE, McVicar EL, Ametrano RM. The relative association between individual difference variables and general psychotherapy outcome expectation in socially anxious individuals. Psychother Res. 2017 Sep;27(5):583-594. doi: 10.1080/10503307.2016.1138336. Epub 2016 Feb 11.

    PubMed 26866269

  • Tzur Bitan D, Lazar A, Siton B. Development of a scale quantifying expectations regarding active processes in therapy: The Expectations of Active Processes in Psychotherapy Scale (EAPPS). Psychiatry Res. 2018 Sep;267:131-139. doi: 10.1016/j.psychres.2018.05.040. Epub 2018 May 21.

    PubMed 29890376

  • Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.

    PubMed 11132119

  • Guy W. Hamilton Depression Scale. In: ECDEU Assessment Manual for Psychopharmacology. 1976:179-192. Revised 1976, DHEW Publication No. (ADM) 76-338.

  • Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.

    PubMed 20526405

  • Brugnera A, Constantino MJ, Grossman-Giron A, Ben David T, Tzur Bitan D. Patient and therapist change process expectations: Independent and dyadic associations with psychotherapy outcomes. Psychother Res. 2025 Apr;35(4):627-636. doi: 10.1080/10503307.2024.2328302. Epub 2024 Mar 14.

    PubMed 38484281

  • Tzur Bitan D, Ben David T, Moshe-Cohen R, Kivity Y. Patient-therapist congruence and incongruence of process expectations during psychotherapy. Psychotherapy (Chic). 2021 Dec;58(4):493-498. doi: 10.1037/pst0000410.

    PubMed 34881924

  • Constantino MJ, Boswell JF, Coyne AE, Swales TP, Kraus DR. Effect of Matching Therapists to Patients vs Assignment as Usual on Adult Psychotherapy Outcomes: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Sep 1;78(9):960-969. doi: 10.1001/jamapsychiatry.2021.1221.

    PubMed 34106240

Questions about this trial

What is this clinical trial studying?

An observational study of Expectancy and Distress, Psychological, run by Shalvata Mental Health Center at 1 site in Israel.

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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dana Elberg, MA (+972545551887, danaelbergg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom Checklist (SCL-10R) (time frame: From enrollment, 2 weeks, 4 weeks and 8 weeks after enrolment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06908343, which also lists 16 linked publications.

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 2 May 2025.

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