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

Recruiting

• Conditions: Expectancy; Distress, Psychological

• Registration Number: NCT06908343
• Lead Sponsor: Shalvata Mental Health Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-20
• Study First Submitted: 2025-03-27
• Study First Submitted QC: 2025-03-27
• Status Verified: 2025-04
• Study First Posted: 2025-04-03
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom Checklist (SCL-10R)	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.
The Expectations of Active Processes in Psychotherapy Scale (EAPPS)	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.
Outcome expectations (an item from Credibility/Expectancy Questionnaire (CEQ)	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.
The Clinical Global Impressions Scale (CGI).	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.

Secondary Outcome Measures

Name	Time	Method
The Multitheoretical List of Therapeutic Interventions (MULTI).	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).
The Stanford Expectations of Treatment Scale (SETS)	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".
Existential Isolation Scale (EIS)	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.

Trial Locations

Locations (1)

Shalvata Mental Health Center; 🇮🇱 Israel, Israel