The Effects of an Expectation-focused Nonguided Therapy Preparation (ENThER)

August 6, 2024 updated by: Philipps University Marburg Medical Center

Various studies have shown that a more positive outcome expectation can have an influence on the actual treatment outcome of outpatient psychotherapeutic treatments. Therefore, the aim of this online study is to investigate whether [1] the patients' outcome expectation of outpatient psychotherapy can be optimized by a brief nonguided online intervention and whether [2] this intervention can influence important factors of psychotherapy, such as active cooperation, the therapeutic relationship, motivation, and regular attendance to therapy.

To examine these questions, patients who are waiting for outpatient therapy will be randomized into two groups (control vs. intervention group) after baseline assessment. The intervention group will participate in a brief therapy preparation (30 minutes) that focuses on optimizing outcome expectations. Both groups will fill out questionnaires again on the following day, during the diagnostic phase at the beginning of therapy and six months later (or at the end of therapy in case therapy ends before the 6-month-follow-up). Furthermore, therapists will also fill out questionnaires during the diagnostic phase at the beginning of therapy and six months later (or at the end of therapy in case therapy ends before the 6-month-follow-up).

Study Overview

Status

Status

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

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.
Interventional

Enrollment (Actual)

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.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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 Contact Backup

Study Locations

  • Germany
      • Marburg, Germany, 35032
        • Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients who are waiting for therapy at the ambulance for psychotherapy Marburg ("Psychotherapie-Ambulanz Marburg")
  • Age 18 or above
  • Fluency in German
  • Informed consent

Exclusion Criteria:

  • visual or hearing impairment that interferes with viewing or listening to video recordings

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Experimental: Intervention group
Behavioral: Expectation-focused online intervention
Patients receive an expectation-focused online intervention (around 30 minutes) consisting of a video with general information about psychotherapy, a video with reports of patients' therapy experiences, questions on the content of the videos as well as open questions on personal strengths, fears and expectations in the context of therapy. This intervention aims to optimize patients' expectations by focusing on positive and realistic expectations regarding the psychotherapeutic process.

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
Change in outcome expectation (Credibility and Expectancy Questionnaire (CEQ) scale) from Baseline to T1
Time Frame: Baseline, T1 (following day)
German version of the Credibility and Expectancy Questionnaire (CEQ), 6-item scale (Raeke, 2013).The CEQ consists of two subscales with four items measuring cognitive-focused credibility (e.g., "At this point, how logical does the therapy offered to you seem?") and two items measuring affect-focused expectations (e.g., "By the end of the therapy period, how much improvement in your symptoms do you really feel will occur?"). The CEQ applies different rating scales; a 9-point scale ranging from 1 (not at all) to 9 (very much) and a percentage rating scale ranging from 0% (not at all) to 100% (very much) with higher sum scores indicating greater treatment credibility and expectations.
Baseline, T1 (following day)

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
Change in outcome expectation (Credibility and Expectancy Questionnaire (CEQ) scale) from Baseline to T2 to T3
Time Frame: Baseline, T2 (start of therapy), T3 (6-month-follow-up)
German version of the Credibility and Expectancy Questionnaire (CEQ), 6-item scale (Raeke, 2013).The CEQ consists of two subscales with four items measuring cognitive-focused credibility (e.g., "At this point, how logical does the therapy offered to you seem?") and two items measuring affect-focused expectations (e.g., "By the end of the therapy period, how much improvement in your symptoms do you really feel will occur?"). The CEQ applies different rating scales; a 9-point scale ranging from 1 (not at all) to 9 (very much) and a percentage rating scale ranging from 0% (not at all) to 100% (very much) with higher sum scores indicating greater treatment credibility and expectations.
Baseline, T2 (start of therapy), T3 (6-month-follow-up)
Change in outcome expectation and process expectations (Milwaukee Psychotherapy Expectations Questionnaire (MPEQ)) from Baseline to T1 to T2 to T3
Time Frame: Baseline, T1 (following day), T2 (start of therapy), T3 (6-month-follow-up)
German version of the Milwaukee Psychotherapy Expectations Questionnaire (MPEQ), measures outcome expectations and process expectations (Norberg et al., 2011) with four outcome expectation questions, ask about expected improvements in self-respect, strength to avoid feelings of distress, being a better person, and being a more optimistic person by the end of therapy.
Baseline, T1 (following day), T2 (start of therapy), T3 (6-month-follow-up)
Change in scores on the subscale for treatment expectations of the the generic rating scale for previous treatment experiences, treatment expectations, and treatment effects (GEEE) from baseline to T1 to T2 to T3
Time Frame: Baseline, T1 (following day), T2 (start of therapy), T3 (6-month-follow-up)
Prior experiences with psychotherapy and treatment expectations are measured via the generic rating scale for previous treatment experiences, treatment expectations, and treatment effects (GEEE), subscale for previous treatment experiences and subscale for treatment expectations (Rief et al., 2021). Answers are provided on a numeric rating scale ranging from 0 to 10.
Baseline, T1 (following day), T2 (start of therapy), T3 (6-month-follow-up)
Change in symptom severity (Beck Depression Inventory (BDI-II), Patient Health Questionnaire 4 (PHQ-4), Symptom Checklist-90-Revised (SCL-90-R))
Time Frame: Baseline, T2 (start of therapy), T3 (6-month-follow-up)

BDI-II:

Self-report questionnaire to assess subjective depression symptomatology; 21 items (each item response is scored 0-3); total scores range from 0 - 63 (higher scores indicate more depressiveness)

SCL-90-R:

Self-report questionnaire to evaluate a broad range of psychological problems and symptoms of psychopathology, 90 items, 5-point rating scale.

PHQ-4:

Self-report questionnaire to screen for psychological distress, 4-point rating scale, total scores range from 0 - 12, subscales for depression and anxiety range from 0 - 6.
Baseline, T2 (start of therapy), T3 (6-month-follow-up)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
General Self-Efficacy Scale (GSE)
Time Frame: Baseline, T1 (following day), T2 (start of therapy), T3 (6-month-follow-up)
Self-efficacy via the German version of the General Self-Efficacy Scale (GSE), a 10-item scale measuring general self-efficacy. 10 items, 4-point Likert-scale ranging from 1 to 4, total score ranges from 10 - 40 with high scores indicating high levels of general self efficacy perceptions.
Baseline, T1 (following day), T2 (start of therapy), T3 (6-month-follow-up)
Therapeutic Relationship (Helping Alliance Questionaire (HAQ))
Time Frame: T2 (start of therapy), T3 (6-month-follow-up)
HAQ is a self-report questionnaire made up from 12 questions concerning the perceived therapeutic relationship and the therapeutic process can be answered as well by the patient as by the therapist. 6-point rating scale, total score and two subscales ("relation to the therapist" and "satisfaction with therapeutic outcome").
T2 (start of therapy), T3 (6-month-follow-up)
Treatment adherence
Time Frame: T2 (start of therapy), T3 (6-month-follow-up)
active participation in and between therapy sessions, count of missed sessions
T2 (start of therapy), T3 (6-month-follow-up)
Patients' Illness Perception (Brief Illness Perception Questionnaire, B-IPQ)
Time Frame: Baseline, T1 (following day), T2 (start of therapy), T3 (6-month-follow-up)
The B-IPQ surveys the cognitive and emotional representations of illness. Item 1-5 measure cognitive illness representations (consequences, timeline, personal control, treatment control, and identity). Item 6 and 8 quantify emotional representations (concern & emotions). Item 7 assesses illness comprehensibility. Item 9 is an open question (three most important causal factors in their illness). Items range from 0-10.
Baseline, T1 (following day), T2 (start of therapy), T3 (6-month-follow-up)
Previous treatment experiences on the subscale for previous treatment experiences of the generic rating scale for previous treatment experiences, treatment expectations, and treatment effects (GEEE)
Time Frame: Baseline
Prior experiences with psychotherapy are measured via the generic rating scale for previous treatment experiences, treatment expectations, and treatment effects (GEEE), subscale for previous treatment experiences (Rief et al., 2021). Answers are provided on a numeric rating scale ranging from 0 to 10.
Baseline
Social Support (ESSI-D)
Time Frame: T1 (following day), T2 (start of therapy), T3 (6-month-follow-up)
The german version of the 5-item version of the "ENRICHD Social Support Instrument" (ESSI) measures the perceived social support, 5-point Likert-scale.
T1 (following day), T2 (start of therapy), T3 (6-month-follow-up)
Personality (Big Five Inventory, BFI-10)
Time Frame: Baseline
Items range from 1 - 5. The questionnaire includes the scales "openness to experience", "conscientiousness", "extraversion", agreeableness and neuroticism.
Baseline

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.
Philipps University Marburg Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Winfried Rief, Prof. Dr., Clinical Psychology and Psychotherapy Dept. of Psychology, Philipps-University Marburg

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.
September 15, 2022

Primary Completion (Actual)

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.
March 18, 2024

Study Completion (Actual)

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.
March 31, 2024

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).
August 26, 2022

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.
August 26, 2022

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.
August 29, 2022

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.
August 7, 2024

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.
August 6, 2024

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.
August 1, 2024

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.
  • ENThER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual patient data will be shared with researchers providing a relevant and methodologically sound proposal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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