NCT05245370

Brief Summary

Research has shown that treatment expectations play a major role in the course of mental disorders and that positive expectations have a beneficial impact on treatment outcomes. Expectations can develop in different ways, whereby an emerging body of research has shown that social learning plays a significant role in this process. To date, most studies have investigated the impact of social learning on treatment expectations in the context of pain relief. Little is known about the impact of social learning in the psychotherapeutic treatment of depression. Therefore, this study investigates whether treatment expectations regarding the treatment of depression can be modulated via social learning, i.e., showing positive treatment testimonials. Hypotheses: H1: The investigators predict that individuals who are provided with treatment testimonials (experimental groups) show a greater change toward positive treatment expectations compared to individuals who do not view such testimonials (control groups). H2: The investigators predict that individuals provided with treatment testimonials will, compared to the control groups, show a greater change in secondary outcome variables in the following ways: a greater decrease in perceived uncertainty/ barriers; a greater decrease in stigma/ negative attitudes toward psychotherapy; a greater increase in intentions to seek therapy; a greater willingness to try the specific technique described in the videos. H3: Inter-individual differences in the effect of provided testimonials are associated with pre-existing factors: level of depressive symptoms; intolerance of uncertainty; treatment experience; locus of control; general self-efficacy; dispositional optimism and cognitive immunization tendencies. Exploratory questions:

  1. 1.An exploratory aim of this study is to assess whether viewing different types of testimonials (clinician delivered; patient-delivered; combination of both) has differential effects on treatment expectation change.
  2. 2.Furthermore, the investigators want to assess whether implicit treatment expectations change in a similar pattern as explicit treatment expectations.
  3. 3.Based on the results of H1 and H2, the investigators aim to assess possible mechanisms of change: e.g. assess whether a change in treatment expectations is mediated by a decrease in perceived uncertainty or a change in stigma/ attitudes toward therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

January 22, 2022

Last Update Submit

September 28, 2022

Conditions

Keywords

treatment expectationssocial learningpsychotherapydepressiontestimonials

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in scores on the Credibility and Expectancy Questionnaire (CEQ) scale

    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; post-Intervention (1 day after baseline, after viewing the intervention videos)

Secondary Outcomes (8)

  • Change from baseline in scores on the Treatment Expectation Questionnaire (TEX-Q)

    Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos)

  • Change from baseline in scores on the subscale for treatment expectations of the the generic rating scale for previous treatment experiences, treatment expectations, and treatment effects (GEEE)

    Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos)

  • Change from baseline in D-Scores on the Single-Category Implicit Associations Test (SC-IAT)

    Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos)

  • Change from baseline in scores on the Credibility and Personal Reaction Scale

    Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos)

  • Change from baseline in scores on perceived uncertainty and perceived barriers to psychotherapy

    Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos)

  • +3 more secondary outcomes

Other Outcomes (9)

  • Patient Health Questionnaire (PHQ-9)

    Baseline

  • General Self-Efficacy Scale (GSE)

    Baseline

  • Empathy on the Interpersonal Reactivity Index (IRI)

    Baseline

  • +6 more other outcomes

Study Arms (5)

Control group 1: Control video

ACTIVE COMPARATOR
Behavioral: Control video

Control group 2: Rationale video + control video

ACTIVE COMPARATOR
Behavioral: Control videoBehavioral: Rationale video

Rationale video + clinician testimonial

EXPERIMENTAL
Behavioral: Rationale videoBehavioral: Clinician testimonial

Rationale video + patient testimonial

EXPERIMENTAL
Behavioral: Rationale videoBehavioral: Patient testimonial

Rationale video + clinician testimonial + patient testimonial

EXPERIMENTAL
Behavioral: Rationale videoBehavioral: Clinician testimonialBehavioral: Patient testimonial

Interventions

Control videoBEHAVIORAL

Control group 1 will see a control video consisting of basic information about the different types of psychotherapy that are covered by insurance in Germany and the process of applying for psychotherapy with the insurance. The control video is matched in duration (10 minutes), set-up and the overall topic (psychotherapy) to the intervention video testimonials.

Control group 1: Control videoControl group 2: Rationale video + control video
Rationale videoBEHAVIORAL

The active control group 2 will see a short rationale and the control video. The rationale is a 2:45 minute-long animated video (designed via the visual communication platform powtoon, https://powtoon.com/) explaining some of the underlying mechanisms of depression.

Control group 2: Rationale video + control videoRationale video + clinician testimonialRationale video + clinician testimonial + patient testimonialRationale video + patient testimonial

This group will see the rationale video first, followed by testimonial of a professional clinician/psychotherapist.

Rationale video + clinician testimonialRationale video + clinician testimonial + patient testimonial

This group will see the rationale video first, followed by testimonial of a patient who is being treated for depression with psychotherapy.

Rationale video + clinician testimonial + patient testimonialRationale video + patient testimonial

Eligibility Criteria

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

You may qualify if:

  • at least 18 years old
  • be able understand German (at least B1 level)
  • have access to a computer device with internet access

You may not qualify if:

  • age below 18 years old
  • non correctable hearing or visual impairment

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

MeSH Terms

Conditions

Patient Acceptance of Health CareDepression

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorBehavioral Symptoms

Study Officials

  • Winfried Rief

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Dr.

Study Record Dates

First Submitted

January 22, 2022

First Posted

February 17, 2022

Study Start

January 14, 2022

Primary Completion

April 15, 2022

Study Completion

April 15, 2022

Last Updated

September 29, 2022

Record last verified: 2022-09

Locations