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

NCT06908343 | Recruiting DMC

• 1 other identifier: 0012-22 SHA
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Expectancy; Distress, Psychological

Keywords

process expectations; distress; hospitalized patients; psychotherapy

Outcome Measures

Primary Outcomes (4)

• 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.

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

• 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.

  At enrollment and 8 weeks after enrolment

• 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.

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

• 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.

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

Secondary Outcomes (3)

• The Multitheoretical List of Therapeutic Interventions (MULTI).

  2 weeks and 4 weeks after enrollment

• The Stanford Expectations of Treatment Scale (SETS)

  At enrollment and 6 weeks after enrollment

• Existential Isolation Scale (EIS)

  At enrollment and 8 weeks after enrollment

Study Arms (1)

Patients at Shalvata Mental Health Center

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shalvata Mental Health Center: lead

Study Sites (1)

Shalvata Mental Health Center

Israel, Israel

RECRUITING

Related Publications (16)

• 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.

  PMID: 23169874 BACKGROUND

• 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.

  PMID: 19065285 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29336228 BACKGROUND

• 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.

  PMID: 10868247 BACKGROUND

• 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.

  PMID: 4682398 BACKGROUND

• 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.

  PMID: 38565810 BACKGROUND

• 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.

  PMID: 26866269 BACKGROUND

• 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.

  PMID: 29890376 BACKGROUND

• 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.

  PMID: 11132119 BACKGROUND

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

  BACKGROUND

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

  PMID: 20526405 BACKGROUND

• 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.

  PMID: 38484281 BACKGROUND

• 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.

  PMID: 34881924 BACKGROUND

• 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.

  PMID: 34106240 BACKGROUND

• Constantino MJ, Aviram A, Coyne AE, Newkirk K, Greenberg RP, Westra HA, Antony MM. Dyadic, longitudinal associations among outcome expectation and alliance, and their indirect effects on patient outcome. J Couns Psychol. 2020 Jan;67(1):40-50. doi: 10.1037/cou0000364. Epub 2019 Jun 17.

  PMID: 31204836 BACKGROUND

Central Study Contacts

Dana Elberg, MA

CONTACT

+972545551887; danaelbergg@gmail.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: OTHER
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dana Tzur Bitan

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: February 20, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

IL (1)