Efficacy of open-label placebos (OLPs) during the waiting period for outpatient psychotherapy.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037528

Enrollment

Registered

2025-08-07

Start date

2026-03-10

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Indication for outpatient psychotherapy with ICD-diagnosis

Interventions

Group 1: Intervention group: Patients who receive an open-label placebo (OLP) intervention during the waiting period for outpatient psychotherapy. Participants can choose one out of seven available OL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Participants must have a treatment-seeking intention for outpatient systemic psychotherapy and a confirmed indication for psychotherapy provided by licensed psychotherapeutic professionals. Participants must have been placed on the waiting list of the respective outpatient psychotherapy clinic. The expected waiting time for psychotherapy must be at least four weeks. Participants must have sufficient proficiency in the German language to understand and complete the questionnaires and must provide written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: Exclusion criteria are: - Acute suicidality, - Acute crisis situations - Significant cognitive impairments - Psychotic symptoms - Patient is already undergoing psychotherapy.

Design outcomes

Primary

Measure	Time frame
The primary outcome is the change in psychological distress, operationalized using the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) at measurement occasion t2. The PHQ-ADS comprises the Generalized Anxiety Disorder scale (GAD-7) and the Patient Health Questionnaire (PHQ-8) assessing depressive symptoms. Data are collected prior to the start of the intervention (baseline, t0), after randomization and prior to the start of the intervention or waiting period (t1; assessment of general and specific improvement expectations only), and four weeks later, after completion of the intervention or waiting period (post-intervention, t2).	—

Measure

Time frame

The primary outcome is the change in psychological distress, operationalized using the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) at measurement occasion t2. The PHQ-ADS comprises the Generalized Anxiety Disorder scale (GAD-7) and the Patient Health Questionnaire (PHQ-8) assessing depressive symptoms. Data are collected prior to the start of the intervention (baseline, t0), after randomization and prior to the start of the intervention or waiting period (t1; assessment of general and specific improvement expectations only), and four weeks later, after completion of the intervention or waiting period (post-intervention, t2).

—

Secondary

Measure	Time frame
Secondary outcomes assess additional potential effects of the intervention and are operationalized as follows: - Perceived stress measured using the Perceived Stress Scale (PSS-10) - Life satisfaction measured using the Satisfaction with Life Scale (SWLS) - Health-related quality of life assessed using the EQ-5D - Sleep quality and daytime functioning measured using the Athens Insomnia Scale for Non-Clinical Application (AIS-NCA) - General psychological distress measured using the General Health Questionnaire (GHQ-12) - Change in individually defined symptoms assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) - Moderation analyses: Baseline treatment expectations assessed with the Treatment Expectation Questionnaire (TEX-Q) and baseline general self-efficacy assessed with the General Self-Efficacy Scale (GSE) - Exploratory mediation analysis: Changes in general self-efficacy (GSE) between t0 and t2 are examined as potential mediators of the effects of the OLP intervention - In addition, potential harms are assessed using an open-ended free-text field.	—

Measure

Time frame

Secondary outcomes assess additional potential effects of the intervention and are operationalized as follows: - Perceived stress measured using the Perceived Stress Scale (PSS-10) - Life satisfaction measured using the Satisfaction with Life Scale (SWLS) - Health-related quality of life assessed using the EQ-5D - Sleep quality and daytime functioning measured using the Athens Insomnia Scale for Non-Clinical Application (AIS-NCA) - General psychological distress measured using the General Health Questionnaire (GHQ-12) - Change in individually defined symptoms assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) - Moderation analyses: Baseline treatment expectations assessed with the Treatment Expectation Questionnaire (TEX-Q) and baseline general self-efficacy assessed with the General Self-Efficacy Scale (GSE) - Exploratory mediation analysis: Changes in general self-efficacy (GSE) between t0 and t2 are examined as potential mediators of the effects of the OLP intervention - In addition, potential harms are assessed using an open-ended free-text field.

—

Countries

Germany

Contacts

Public ContactStefan Schmidt

Universitätsklinikum Freiburg - Klinik für Psychosomatik

stefan.schmidt@uniklinik-freiburg.de+4976127069280

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026