ExpectationsENThERNCT05519722
The Effects of an Expectation-focused Nonguided Therapy Preparation
A study testing Expectation-focused online intervention in people with Expectations, run by Philipps University Marburg at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Expectations
- What is being tested?
- Expectation-focused online intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteGermany
- Study dates
- 15 Sep 2022to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who are waiting for therapy at the ambulance for psychotherapy Marburg ("Psychotherapie-Ambulanz Marburg")
- Age 18 or above
- Fluency in German
- Informed consent
Who cannot join
- visual or hearing impairment that interferes with viewing or listening to video recordings
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg
Marburg, 35032
About this study
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).
- Conditions
- Expectations
- Being tested
- Expectation-focused online intervention
- Keywords
- expectations, intervention, online, psychotherapy, patients, waitlist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expectation-focused online interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: Expectation-focused online intervention |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in outcome expectation (Credibility and Expectancy Questionnaire (CEQ) scale) from Baseline to T1
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.
Measured: Baseline, T1 (following day)
Secondary outcomes (4)
Change in outcome expectation (Credibility and Expectancy Questionnaire (CEQ) scale) from Baseline to T2 to T3
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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))
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.
Measured: Baseline, T2 (start of therapy), T3 (6-month-follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start15 Sep 2022
- Primary completion18 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExpectationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be randomly distributed to the intervention group or the control group. The intervention group will receive a nonguided online-intervention to optimize expectations. The control group will receive no intervention at all.
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Winfried Rief, Prof. Dr., Principal investigator, Clinical Psychology and Psychotherapy Dept. of Psychology, Philipps-University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519722
- Sponsor's protocol ID
- ENThER
- Acronym
- ENThER
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2022
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual patient data will be shared with researchers providing a relevant and methodologically sound proposal
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Expectation-focused Nonguided Therapy Preparation
- ClinicalTrials.gov ID
- NCT05519722
- Acronym / sponsor ID
- ENThER / ENThER
- Conditions
- Expectations
- Keywords
- expectations, intervention, online, psychotherapy, patients, waitlist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 18 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients will be randomly distributed to the intervention group or the control group. The intervention group will receive a nonguided online-intervention to optimize expectations. The control group will receive no intervention at all.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Expectation-focused online intervention |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients who are waiting for therapy at the ambulance for psychotherapy Marburg ("Psychotherapie-Ambulanz Marburg")
- Age 18 or above
- Fluency in German
- Informed consent
Key exclusion criteria (1 listed)
- visual or hearing impairment that interferes with viewing or listening to video recordings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expectation-focused online interventionPatients 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. | Behavioural | Intervention group |
Primary outcome
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.
4 secondary outcomes
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: Undecided. Individual patient data will be shared with researchers providing a relevant and methodologically sound proposal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winfried Rief, Prof. Dr. principal investigator
Clinical Psychology and Psychotherapy Dept. of Psychology, Philipps-University Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expectation-focused online intervention in people with Expectations, run by Philipps University Marburg at 1 site in Germany.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 7 Aug 2024. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in outcome expectation (Credibility and Expectancy Questionnaire (CEQ) scale) from Baseline to T1 (time frame: Baseline, T1 (following day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2024.