Health Care UtilizationNCT05245370
Modifying Treatment Expectations in Depression: the Role of Social Learning
A study testing Rationale video, Clinician testimonial and Patient testimonial in people with Health Care Utilization, run by Philipps University Marburg at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Care Utilization
- What is being tested?
- Rationale video, Clinician testimonial and Patient testimonial
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteGermany
- Study dates
- 14 Jan 2022to 15 Apr 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 years old
- be able understand German (at least B1 level)
- have access to a computer device with internet access
Who cannot join
- age below 18 years old
- non correctable hearing or visual impairment
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
Official title: Social Learning Trial: Using Patient and Clinician Testimonials to Modify Treatment Expectations and Placebo Treatments in Depression
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:
Read more
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:
- 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.
- Furthermore, the investigators want to assess whether implicit treatment expectations change in a similar pattern as explicit treatment expectations.
- 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.
- Conditions
- Health Care Utilization
- Being tested
- Control video, Rationale video, Clinician testimonial, Patient testimonial
- Keywords
- treatment expectations, social learning, psychotherapy, depression, testimonials
- Medical subject headings
- Patient Acceptance of Health Care, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control videoBehavioural
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.
Rationale videoBehavioural
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.
Clinician testimonialBehavioural
This group will see the rationale video first, followed by testimonial of a professional clinician/psychotherapist.
Patient testimonialBehavioural
This group will see the rationale video first, followed by testimonial of a patient who is being treated for depression with psychotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Control group 1: Control video | Active comparator | Not described Receives: Behavioral: Control video |
| Control group 2: Rationale video + control video | Active comparator | Not described Receives: Behavioral: Control video; Behavioral: Rationale video |
| Rationale video + clinician testimonial | Experimental | Not described Receives: Behavioral: Rationale video; Behavioral: Clinician testimonial |
| Rationale video + patient testimonial | Experimental | Not described Receives: Behavioral: Rationale video; Behavioral: Patient testimonial |
| Rationale video + clinician testimonial + patient testimonial | Experimental | Not described Receives: Behavioral: Rationale video; Behavioral: Clinician testimonial; Behavioral: Patient testimonial |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
German version of the Treatment Expectation Questionnaire (TEX-Q), measuring expectations towards psychotherapy in general and towards the process of a psychotherapy (Alberts et al., 2020). Answers are given on a 11-point Likert scale ranging from 0 to 10 (each item has specific anchors with lower anchors always indicating no expected change); The TEX-Q consists of 6 subscales: Treatment benefit (mean item 1,2,3), positive impact (mean item 4,5,6), adverse events (mean item 7,8,9), negative impact (mean item 10,11), process (mean item 12,13), behavioral control (mean item 14,15). TEX-Q overall mean score: mean of all items after inverting items 7-11 with higher scores indicating greater expectations and credibility
Measured: 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)
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 (each item has specific anchors with lower anchors always indicating no expected effects)
Measured: 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)
Single-Category Implicit Associations Test (SC-IAT) (Karpinski \& Steinman, 2006), measuring implicit associations with psychotherapy. It is a reaction-time task facing the target dimension 'psychotherapy' and the evaluative dimensions 'effective' and 'ineffective'. The strength of the association (D-score) between the target dimension and the evaluative dimension is calculated based on the reaction times. Shorter reaction times indicate a greater associative strength.
Measured: Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos)
Change from baseline in scores on the Credibility and Personal Reaction Scale
Credibility of and personal reactions to psychotherapy are measured via a self-translated German version of the Credibility \& Personal Reaction Scales, adapted from Borkovec and Nau (1972) by Addis and Carpenter (1999). This scale also measures intentions to seek therapy.
Credibility scale: 7 items, answers are provided on a 7-point Likert scale from 1 (not at all) to 7 (extremely).
Personal Reactions to the Rationales (PRR): 5 items, answers are provided on a 7-point Likert scale from 1 (not at all) to 7 (extremely).
The total score of the credibility scale ranges from 7 to 49 with higher scores indicating higher credibility ratings, the total PRR score ranges from 5 to 35 with higher scores indicating more positive reactions and higher credibility.
Measured: 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
The items used by Kushner and Sher (1989), to assess perceived barriers were translated to German and modified to state "I am uncertain" instead of "I am anxious" (original: Kushner, M. G., \& Sher, K. J. (1989). Fear of psychological treatment and its relation to mental health service avoidance. Professional Psychology: Research and Practice, 20(4), 251-257). The scale consists of 3 subscales: therapist responsiveness (5 items), image concerns (4 items), coercion concerns (4 items). Answers are provided on a 5-point scale ranging from 1 (not at all) to 5 (completely) with high scores indicating greater uncertainty. Five items to reflect specific uncertainties (financial concerns, time restrictions, therapist relatability, the therapeutic process, personal ability to complete therapy), that were not covered by the original article, were added. Answers are provided on a 5-point scale ranging from 1 (do not agree) to 5 (agree) with high scores indicating greater uncertainty.
Measured: Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos)
Change from baseline in scores on the Perceived Stigma subscale of the Depression Stigma Scale (DSS)
Public Stigma of depression are measured via the German translation of the Depression Stigma Scale (DSS)(Griffiths et al., 2018), using the Perceived Stigma subscale: 9 items, measuring perceived public stigma of depression. Answers are provided on a 5-point Likert-scale ranging from 0 (completely disagree) to 4 (completely agree); total scores range from 0 to 36 with higher scores indicating greater perceived stigma.
Measured: Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos)
Change from baseline in scores on the Self-Stigma of Depressions Scale (SSDS)
German version of the Self-Stigma of Depressions Scale (SSDS), 16 items measuring anticipated self-stigma for the hypothetical case that one would be suffering from depression (Makowski et al., 2018). The SSDS consists of 3 subscales: self-blame, help-seeking inhibition, social inadequacy Answers on all items are given on a 5-point Likert-scale ranging from 1 (completely disagree) to 5 (completely agree); higher scores indicate higher self-stigma.
Measured: Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos)
Change from baseline in scores on the attitudes towards seeking professional psychological help scale (ATTSPPH-SF)
Attitudes towards seeking professional psychological help (ATTSPPH-SF) - German translation of the short form: 10 items measuring attitudes towards seeking therapy for mental illness (Fischer \& Farina, 1995). Answers are given on a 4-point Likert-scale ranging from 0 (disagree) to 3 (agree). The ATTSPPH-SF measures 2 dimensions: openness to seeking professional help for emotional problems (items 1, 3, 5, 6, 7; ) and value and need in seeking professional help (items 2, 4, 8, 9, 10; items inverted: 0 = agree and 3 = disagree). The total score of the scale ranges from 0 to 30 with higher scores indicating a better help-seeking attitude.
Measured: Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start14 Jan 2022
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care UtilizationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Winfried Rief, Philipps University Marburg
- Investigators
- Winfried Rief, Principal investigator, Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Germany, 35032
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245370
- Sponsor's protocol ID
- Social learning_testimonials
- Status last verified
- Sep 2022
- First submitted
- 22 Jan 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Learning Trial: Using Patient and Clinician Testimonials to Modify Treatment Expectations and Placebo Treatments in Depression
- ClinicalTrials.gov ID
- NCT05245370
- Acronym / sponsor ID
- Social learning_testimonials
- Conditions
- Health Care Utilization
- Keywords
- treatment expectations, social learning, psychotherapy, depression, testimonials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 17 Feb 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.
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:
- 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.
- Furthermore, the investigators want to assess whether implicit treatment expectations change in a similar pattern as explicit treatment expectations.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control group 1: Control video | Active comparator | Behavioral: Control video |
| Control group 2: Rationale video + control video | Active comparator | Behavioral: Control video, Behavioral: Rationale video |
| Rationale video + clinician testimonial | Experimental | Behavioral: Rationale video, Behavioral: Clinician testimonial |
| Rationale video + patient testimonial | Experimental | Behavioral: Rationale video, Behavioral: Patient testimonial |
| Rationale video + clinician testimonial + patient testimonial | Experimental | Behavioral: Rationale video, Behavioral: Clinician testimonial, Behavioral: Patient testimonial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 18 years old
- be able understand German (at least B1 level)
- have access to a computer device with internet access
Key exclusion criteria (2 listed)
- age below 18 years old
- non correctable hearing or visual impairment
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 |
|---|---|---|
| Control videoControl 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. | Behavioural | Control group 1: Control video, Control group 2: Rationale video + control video |
| Rationale videoThe 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. | Behavioural | Control group 2: Rationale video + control video, Rationale video + clinician testimonial, Rationale video + clinician testimonial + patient testimonial, Rationale video + patient testimonial |
| Clinician testimonialThis group will see the rationale video first, followed by testimonial of a professional clinician/psychotherapist. | Behavioural | Rationale video + clinician testimonial, Rationale video + clinician testimonial + patient testimonial |
| Patient testimonialThis group will see the rationale video first, followed by testimonial of a patient who is being treated for depression with psychotherapy. | Behavioural | Rationale video + clinician testimonial + patient testimonial, Rationale video + patient testimonial |
Primary outcome
Change from baseline in scores on the Credibility and Expectancy Questionnaire (CEQ) scale
Time frame: Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos)
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.
8 secondary outcomes
Change from baseline in scores on the Treatment Expectation Questionnaire (TEX-Q)
Time frame: 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)
Time frame: 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)
Time frame: Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos)
Change from baseline in scores on the Credibility and Personal Reaction Scale
Time frame: 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
Time frame: Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos)
Change from baseline in scores on the Perceived Stigma subscale of the Depression Stigma Scale (DSS)
Time frame: Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos)
Change from baseline in scores on the Self-Stigma of Depressions Scale (SSDS)
Time frame: Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos)
Change from baseline in scores on the attitudes towards seeking professional psychological help scale (ATTSPPH-SF)
Time frame: Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos)
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 29 Sep 2022.
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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 principal investigator
Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Germany, 35032
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rationale video, Clinician testimonial and Patient testimonial in people with Health Care Utilization, 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 3 inclusion and 2 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 29 Sep 2022. 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 from baseline in scores on the Credibility and Expectancy Questionnaire (CEQ) scale (time frame: Baseline; post-Intervention (1 day after baseline, after viewing the intervention videos)). 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 29 Sep 2022.