NCT05519722

Brief 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 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

September 15, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2024

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

1.5 years

First QC Date

August 26, 2022

Last Update Submit

August 6, 2024

Conditions

Keywords

expectationsinterventiononlinepsychotherapypatientswaitlist

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, T1 (following day)

Secondary Outcomes (4)

  • Change in outcome expectation (Credibility and Expectancy Questionnaire (CEQ) scale) from Baseline to T2 to T3

    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

    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

    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))

    Baseline, T2 (start of therapy), T3 (6-month-follow-up)

Other Outcomes (7)

  • General Self-Efficacy Scale (GSE)

    Baseline, T1 (following day), T2 (start of therapy), T3 (6-month-follow-up)

  • Therapeutic Relationship (Helping Alliance Questionaire (HAQ))

    T2 (start of therapy), T3 (6-month-follow-up)

  • Treatment adherence

    T2 (start of therapy), T3 (6-month-follow-up)

  • +4 more other outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL
Behavioral: Expectation-focused online intervention

Control group

NO INTERVENTION

Interventions

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg

Marburg, 35032, Germany

Location

Study Officials

  • Winfried Rief, Prof. Dr.

    Clinical Psychology and Psychotherapy Dept. of Psychology, Philipps-University Marburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2022

First Posted

August 29, 2022

Study Start

September 15, 2022

Primary Completion

March 18, 2024

Study Completion

March 31, 2024

Last Updated

August 7, 2024

Record last verified: 2024-08

Locations