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AzTrials

Health Care UtilizationNCT05826886

The Effect of Video-based Testimonials About Psychotherapy on Treatment Expectations and a Short Online Intervention

A study testing Emotional Writing in people with Health Care Utilization, run by Philipps University Marburg at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 and an emerging body of research shows that social learning plays a significant role in this… 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?
Emotional Writing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteGermany
Study dates
4 Apr 2023to 1 Oct 2023
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
  • diagnosis of borderline-personality disorder
  • diagnosis of post-traumatic-stress-disorder
  • self-reported suicidality

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg

    Marburg, 35032

Other trials in Germany

About this study

Official title: Social Learning in Depression Therapy: The Effect of Video-based Testimonials About Psychotherapy on a Treatment Expectations and a Short Online Intervention

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 and an emerging body of research shows 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 about depression therapy and treatment effects of a short online intervention can be modulated via social learning, i.e., showing positive treatment testimonials.

Being tested
Emotional Writing
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.

  • Emotional WritingBehavioural

    Also called Expressive Writing

    Participants complete four 20-minute sessions of emotional writing (at home) on four consecutive days. Instructions are provided online before each writing session.

Study groups in NCT05826886
Study groupRoleWhat they receive
Control videoActive comparatorVideo of a woman describing basic information about psychotherapy and how it is embedded in the insurance system in Germany. Personal experience with therapy are not provided. 'Emotional writing' is introduced as a type of intervention used in depression treatment and basic information about it is provided.
Receives: Behavioral: Emotional Writing
TestimonialsExperimentalVideo of a patient and a therapist, who both describe their personal experience of depression therapy in a positive but realistic way. Emphasis is on the personal experience protagonist. 'Emotional writing' is described as a helpful technique from a first person perspective.
Receives: Behavioral: Emotional Writing

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.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; after viewing the videos (1 day after baseline); after completion of the writing intervention (5 days after baseline)

  2. Change from baseline in scores on self-report measure for the Assessment of Emotion Regulation Skills (Fragebogen zur standardisierten Selbsteinschätzung emotionaler Kompetenzen; SEK-27)

    The German SEK-27 is a 27-item scale measuring 9 domains (attention, clarity, body awareness, understanding, acceptance, resilience, self-support, readiness for confrontation, and regulation) of emotion regulation skills. Higher scores on the overall score indicate better emotion regulation skills.

    Measured: Baseline; after completion of the writing intervention (5 days after baseline)

Secondary outcomes (11)

  1. Change from baseline in scores on the Patient Health Questionnaire (PHQ-9)

    Depressive symptoms via the German version of the Patient Health Questionnaire (PHQ-9), 9-item scale. With each item, the PHQ-9 captures one of the nine criteria for major depression posted in the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) using a 4-point Likert-scale ranging from 0 (not at all) to 3 (almost every day). The total score ranges of 0 to 27, whereby a score of 0 to 4 indicates minimal depressive symptomatology, a score of 5 to 9 mild, a score of 10 to 14 moderate, a score of 15 to 19 moderate to severe, and a total score of 20 to 27 severe depressive symptomatology.

    Measured: Baseline; after completion of the writing intervention (5 days after baseline)

  2. Change from baseline in subjective stress scores on the 'Perceived Stress Scale' (PSS-10)

    Self-report questionnaire to assess subjective stress experience; 10 items; each item is rated on a 5-point scale from 0(never) to 4(very often); total scores range between 0 and 40 (higher scores indicate more subjective stress).

    Measured: Baseline; after completion of the writing intervention (5 days after baseline)

  3. Change from baseline in scores on Regulatory Emotional Self-Efficacy Scale (RESE)

    The German version of the RESE is a 10-item instrument measuring self-efficacy for emotion regulation. Items are scored on a Likert Scale ranging from 1 (not well at all) to 5 (very well). Higher scores indicate better regulatory emotional self-efficacy.

    Measured: Baseline; after completion of the writing intervention (5 days after baseline)

  4. Change from baseline on the state-anxiety subscale of the 'State-Trait-Anxiety- Depression-Inventory' (STADI)

    Self-report questionnaire to assess state and trait anxiety and depression; 40 (20 state scale; 20 trait scale) items; each item is rated on a 4-point scale from 1(not at all) to 4(very much); total scores per scale range between 20 and 80 (higher scores indicate more anxiety)

    Measured: Baseline; after completion of the writing intervention (5 days after baseline)

  5. Change from baseline in scores on specific emotion regulation items

    Because we felt that the existing emotion regulation scales used in this study did not capture the some of the specific skills that the emotional writing intervention targets, we created a set of five specific items about allowing, accepting, experiencing and managing negative emotions. Items are scored on a Likert Scale ranging from 1 (do not agree at all) to 5 (agree completely). Higher scores indicate better emotion regulation abilities.

    Measured: Baseline; after completion of the writing intervention (5 days after baseline)

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

    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. 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; after viewing the videos (1 day after baseline); after completion of the writing intervention (5 days after baseline)

  7. 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". 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; after viewing the videos (1 day after baseline)

  8. 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 Scale. 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; after viewing the videos (1 day after baseline); after completion of the writing intervention (5 days after baseline)

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

    Single-Category Implicit Associations Test (SC-IAT), 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; after viewing the videos (1 day after baseline)

  10. 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. 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; after viewing the videos (1 day after baseline)

  11. Change from baseline in the items assessing expectations about dealing with negative emotions of the Depressive Expectations Scale (DES)

    Part A (6 items) of the Depressive Expectations Scale (DES). Items are scored on a Likert Scale ranging from 1 (do not agree) to 5 (agree). Higher scores indicate stronger negative expectations about dealing with negative emotions.

    Measured: Baseline; after completion of the writing intervention (5 days after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2023
  2. Study start4 Apr 2023
  3. Primary completion1 Oct 2023
  4. Study completion1 Oct 2023

Resources

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
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05826886
Sponsor's protocol ID
Social learning 2_intervention
Status last verified
Nov 2023
First submitted
22 Mar 2023
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Koch SC, Mergheim K, Raeke J, Machado CB, Riegner E, Nolden J, Diermayr G, von Moreau D, Hillecke TK. The Embodied Self in Parkinson's Disease: Feasibility of a Single Tango Intervention for Assessing Changes in Psychological Health Outcomes and Aesthetic Experience. Front Neurosci. 2016 Jul 7;10:287. doi: 10.3389/fnins.2016.00287. eCollection 2016.

    PubMed 27458332

  • Berking, M., & Znoj, H. (2008). Entwicklung und Validierung eines Fragebogens zur standardisierten Selbsteinschätzung emotionaler Kompetenzen (SEK-27). Zeitschrift für Psychiatrie, Psychologie und Psychotherapie, 56(2), 141-153.

  • Lowe B, Kroenke K, Herzog W, Grafe K. Measuring depression outcome with a brief self-report instrument: sensitivity to change of the Patient Health Questionnaire (PHQ-9). J Affect Disord. 2004 Jul;81(1):61-6. doi: 10.1016/S0165-0327(03)00198-8.

    PubMed 15183601

  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PubMed 6668417

  • Gunzenhauser, C., Heikamp, T., Gerbino, M., Alessandri, G., Von Suchodoletz, A., Di Giunta, L., ... & Trommsdorff, G. (2013). Self-efficacy in regulating positive and negative emotions. European Journal of Psychological Assessment, 29(3):197-204.

  • Renner KH, Hock M, Bergner-Kother R, Laux L. Differentiating anxiety and depression: the State-Trait Anxiety-Depression Inventory. Cogn Emot. 2018 Nov;32(7):1409-1423. doi: 10.1080/02699931.2016.1266306. Epub 2016 Dec 8.

    PubMed 27928931

  • Rief, W., Nestoriuc, Y., Mueller, E. M., Hermann, C., Schmidt, K., & Bingel, U. (2021). Generic rating scale for previous treatment experiences, treatment expectations, and treatment effects (GEEE). PsychArchives. https://doi.org/10.23668/PSYCHARCHIVES.4717

  • 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.

  • Addis ME, Carpenter KM. Why, why, why?: Reason-giving and rumination as predictors of response to activation- and insight-oriented treatment rationales. J Clin Psychol. 1999 Jul;55(7):881-94. doi: 10.1002/(sici)1097-4679(199907)55:73.0.co;2-e.

    PubMed 10866023

  • Karpinski A, Steinman RB. The single category implicit association test as a measure of implicit social cognition. J Pers Soc Psychol. 2006 Jul;91(1):16-32. doi: 10.1037/0022-3514.91.1.16.

    PubMed 16834477

  • Makowski AC, Mnich EE, von dem Knesebeck O. [Self-Stigma of Depression Scale SSDS - Evaluation of the German Version]. Psychiatr Prax. 2018 Sep;45(6):314-320. doi: 10.1055/s-0043-104504. Epub 2017 May 12. German.

    PubMed 28499317

  • Kube T, D'Astolfo L, Glombiewski JA, Doering BK, Rief W. Focusing on situation-specific expectations in major depression as basis for behavioural experiments - Development of the Depressive Expectations Scale. Psychol Psychother. 2017 Sep;90(3):336-352. doi: 10.1111/papt.12114. Epub 2016 Dec 9.

    PubMed 27935247

  • Kovaleva, A., Beierlein, C., Kemper, C. J., & Rammstedt, B. (2012). Eine Kurzskala zur Messung von Kontrollüberzeugung: die Skala Internale-Externale-Kontrollüberzeugung-4 (IE-4). (GESIS-Working Papers, 2012/19). Mannheim: GESIS - Leibniz-Institut für Sozialwissenschaften. https://nbn-resolving.org/urn:nbn:de:0168-ssoar-312096

  • Paulus, C. (2009). DER SAARBRÜCKER PERSÖNLICHKEITSFRAGEBOGEN SPF(IRI) ZUR MESSUNG VON EMPATHIE: Psychometrische Evaluation der deutschen Version des Interpersonal Reactivity Index. https://doi.org/10.23668/psycharchives.9249

  • Garnefski, N., & Kraaij, V. (2006). Cognitive emotion regulation questionnaire-development of a short 18-item version (CERQ-short). Personality and individual differences, 41(6), 1045-1053.

Questions about this trial

What is this clinical trial studying?

A study testing Emotional Writing 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 5 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 18 Nov 2023. 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; after viewing the videos (1 day after baseline); after completion of the writing intervention (5 days after baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05826886, which also lists 17 linked publications.

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 18 Nov 2023.

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