Cited by 212Pain Management and Placebo EffectStatistical Methods in Clinical TrialsPsychotherapy Techniques and Applications

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Development of the Stanford Expectations of Treatment Scale (SETS): A tool for measuring patient outcome expectancy in clinical trials

Younger, Jarred, Gandhi, Vanisha, Hubbard, Emily, Mackey, Sean·2012·Clinical Trials

DOI 10.1177/1740774512465064

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Abstract

Background: A patient’s response to treatment may be influenced by the expectations that the patient has before initiating treatment. In the context of clinical trials, the influence of participant expectancy may blur the distinction between real and sham treatments, reducing statistical power to detect specific treatment effects. There is therefore a need for a tool that prospectively predicts expectancy effects on treatment outcomes across a wide range of treatment modalities. Purpose: To help assess expectancy effects, we created the Stanford Expectations of Treatment Scale (SETS): an instrument for measuring positive and negative treatment expectancies. Internal reliability of the instrument was tested in Study 1. Criterion validity of the instrument (convergent, discriminant, and predictive) was assessed in Studies 2 and 3. Methods: The instrument was developed using 200 participants in Study 1. Reliability and validity assessments were made with an additional 423 participants in Studies 2 and 3. Results: The final six-item SETS contains two subscales: positive expectancy (α = 0.81–0.88) and negative expectancy (α = 0.81–0.86). The subscales predict a significant amount of outcome variance (between 12% and 18%) in patients receiving surgical and pain interventions. The SETS is simple to administer, score, and interpret. Conclusion: The SETS may be used in clinical trials to improve statistical sensitivity for detecting treatment differences or in clinical settings to identify patients with poor treatment expectancies.

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Self-citation
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Ho, R. S. T., Ho, F. F., Adams, J., Cramer, H., Leung, B. M. Y., Ward, L., Zhang, Y., & Chung, V. C. (2021) · Integrative Medicine Research · doi:10.1016/j.imr.2021.100771 · Cited by 17
The Influence of Preoperative Mood and Treatment Expectations on Early Postsurgical Acute Pain After a Total Knee Replacement
Stuhlreyer, J., & Klinger, R. (2022) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2022.840270 · Cited by 18
Expectations: How and when do they contribute to placebo analgesia?
Rosenkjær, S., Lunde, S. J., Kirsch, I., & Vase, L. (2022) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2022.817179 · Cited by 17
Blinding and expectancy confounds in psychedelic randomised controlled trials
Muthukumaraswamy, S., Forsyth, A., & Lumley, T. (2021) · doi:10.31234/osf.io/q2hzm · Cited by 15
Blinding Integrity in Psychedelic Randomized Clinical Trials
Orsini, D. K., Wong, S., Luch, S. D. D., Chan, B., Vasudeva, S., Lovell, G. F. M., Le, G. H., Jones, B. D. M., Chisamore, N., Mollica, A., et al. (2026) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2026.0255 · Cited by 19
KALK study: ultrasound guided needling and lavage (barbotage) with steroid injection versus sham barbotage with and without steroid injection - protocol for a randomized, double-blinded, controlled, multicenter study
KALK study group, Moosmayer, S., Ekeberg, O. M., Hallgren, H. B., Heier, I., Kvalheim, S., Blomquist, J., Pripp, A. H., Juel, N. G., Kjellevold, S. H., et al. (2017) · BMC Musculoskeletal Disorders · doi:10.1186/s12891-017-1501-9 · Cited by 15
“On the treatment day, prior to treatment, three patient related outcome scores (Oxford Shoulder Score (OSS) [14, 15], quickDASH upper extremity score [16, 17], EQ-5D-5L general health score [18, 19]) and three visual analogue scales (VAS) for pain at rest, during activity and at night will be completed by the patient,…”
MethodInfluential
Psilocybin for Depression: From Credibility to Feasibility, What’s Missing?
Munafò, A., Arillotta, D., Mannaioni, G., Schifano, F., Bernardini, R., & Cantarella, G. (2022) · Pharmaceuticals · doi:10.3390/ph16010068 · Cited by 15
“Hence, investigators should manage expectations whilst emphasizing the uncertainty regarding the treatment efficacy and measuring participants’ treatment expectations through established measures, such as the Stanford Expectations of Treatment scale [67], both at the baseline and after drug administration.”
Background
The Role of Treatment Perceptions in Intervention Evaluation: A Review
Sidani, S., & Fox, M. T. (2020) · Science of Nursing and Health Practices · doi:10.31770/2561-7516.1079 · Cited by 14
“This improvement, however, may be associated with participants’ placebo response initiated by the anticipated benefits of the treatment more so than with the active ingredients of the treatment to which they were actually exposed and they enacted (Frisaldi et al., 2017; Gaudiano et al., 2013; Younger et al., 2012).”
BackgroundInfluential
Cognitive interviews guide design of a new CAM patient expectations questionnaire
Sherman, K. J., Eaves, E. R., Ritenbaugh, C., Hsu, C. W., Cherkin, D. C., & Turner, J. A. (2014) · BMC Complementary and Alternative Medicine · doi:10.1186/1472-6882-14-39 · Cited by 12
“Cognitive interviews have not been used when developing previously validated questionnaires of treatment expectations [13-15], even though cognitive interviews have been used when developing other questionnaires designed to assess patient reported outcomes [16,17].”
Method
Psilocybin-assisted therapy for severe alcohol use disorder: protocol for a double-blind, randomized, placebo-controlled, 7-month parallel-group phase II superiority trial
Vanderijst, L., Hever, F., Buot, A., Dauré, C., Benoit, J., Hanak, C., Veeser, J., Morgiève, M., Campanella, S., Kornreich, C., et al. (2024) · BMC Psychiatry · doi:10.1186/s12888-024-05502-y · Cited by 13
“Participants’ expectancy will be assessed with the Stanford Expectations of Treatment Scale (SETS; [114]) at baseline, and blinding efficacy will be assessed by asking participants and therapists to guess group allocation and indicate guess certainty following the psilocybin administration session.”
Method
Genomics and Patient Empowerment
McAllister, M. (2015) · Elsevier eBooks · doi:10.1016/b978-0-12-420195-8.00003-3 · Cited by 13
The role of the Nocebo effect in the use of biosimilars in routine rheumatology clinical practice
Kravvariti, E., & Kitas, G. D. (2019) · Mediterranean Journal of Rheumatology · doi:10.31138/mjr.30.1.63 · Cited by 13
Best Practice Recommendations for Conducting and Reporting Controlled Trials in Clinical Hypnosis Research
Kekecs, Z., Moss, D., Whorwell, P. J., Varga, K., Terhune, D. B., Shenefelt, P. D., Palsson, O. S., Benedittis, G. D., & Elkins, G. (2024) · Journal of Evidence-Based Integrative Medicine · doi:10.1177/2515690x241274538 · Cited by 12
“Valid measures of response expectancies include the Stanford Expectations of Treatment Scale (SETS), 87 and the credibility/expectancy questionnaire (CEQ).”
Method
The effects of being told you are in the intervention group on training results: a pilot study
Lindberg, K., Bjørnsen, T., Vårvik, F. T., Paulsen, G., Joensen, M., Kristoffersen, M., Sveen, O., Gundersen, H. S., Slettaløkken, G., Brankovic, R., et al. (2023) · Scientific Reports · doi:10.1038/s41598-023-29141-7 · Cited by 15
Acute Cuff Tear Repair Trial (ACCURATE): protocol for a multicentre, randomised, placebo-controlled trial on the efficacy of arthroscopic rotator cuff repair
Ryösä, A., Kukkonen, J., Hallgren, H. B., Moosmayer, S., Holmgren, T., Ranebo, M. C., Bøe, B., & Äärimaa, V. (2019) · BMJ Open · doi:10.1136/bmjopen-2018-025022 · Cited by 12
“High preoperative expectations are described to correlate with better results after rotator cuff surgery28 29 and low expectations with failure.30 To address the validity of the trial in the light of expectancies,31 32 we measure the preoperative expectations with Stanford Expectations of Treatment Scale.33 Depression…”
Method
Use of Cannabidiol (CBD) oil in the treatment of PTSD: Study design and rationale for a placebo-controlled randomized clinical trial
Telch, M. J., Fischer, C. M., Zaizar, E. D., Rubin, M., & Papini, S. (2022) · Contemporary Clinical Trials · doi:10.1016/j.cct.2022.106933 · Cited by 13
Clinical effectiveness of patella mobilisation therapy versus a waiting list control for knee osteoarthritis: a protocol for a pragmatic randomised clinical trial
Sit, R. W. S., Chan, K. K. W., Yip, B. H. K., Zhang, D. D., Reeves, K. D., Chan, Y. H., Chung, V. C., & Wong, S. Y. S. (2018) · BMJ Open · doi:10.1136/bmjopen-2017-019103 · Cited by 12
“Because the patient’s response to treatment may be influenced by his or her expectations before the start of treatment, reducing the statistical power to detect specific treatment effects, the Stanford Expectations of Treatment Scale will be used to overcome this.(52)”
Method
Use of Immersive Learning and Simulation Techniques to Teach and Research Opioid Prescribing Practices
Heirich, M. S., Sinjary, L. S., Ziadni, M. S., Sacks, S. H., Buchanan, A. S., Mackey, S., & Newmark, J. L. (2018) · Pain Medicine · doi:10.1093/pm/pny171 · Cited by 12
Self-citation
Patients’ expectancy scale of acupuncture: Development and clinical performance test
Yang, X., Xia, W., Xu, Y., Han, F., Yan, S., Liu, Y., Wang, T., Zhou, J.-N., Chen, N., Zeng, X., et al. (2023) · Complementary Therapies in Clinical Practice · doi:10.1016/j.ctcp.2023.101797 · Cited by 11
An Intervention for the Transition From Pediatric or Adolescent to Adult-Oriented HIV Care: Protocol for the Development and Pilot Implementation of iTransition
Tanner, A. E., Dowshen, N., Philbin, M. M., Rulison, K. L., Camacho-González, A., Lee, S., Moore, S. J., Fortenberry, J. D., & Hussen, S. A. (2021) · JMIR Research Protocols · doi:10.2196/24565 · Cited by 12
Fear of compassion is associated with treatment ambivalence and negative expectations for treatment in people with anxiety
Merritt, O. A., & Purdon, C. (2021) · British Journal of Clinical Psychology · doi:10.1111/bjc.12313 · Cited by 10
Mindfulness-Based Stress Reduction, Cognitive Behavioral Therapy, and Acupuncture in Chronic Low Back Pain: Protocol for Two Linked Randomized Controlled Trials
Mackey, S., Gilam, G., Darnall, B. D., Goldin, P. R., Kong, J., Law, C. S. W., Heirich, M. S., Karayannis, N. V., Kao, M. J., Tian, L., et al. (2022) · JMIR Research Protocols · doi:10.2196/37823 · Cited by 13
Self-citation
Probing the functional magnetic resonance imaging response to psilocybin in functional neurological disorder (PsiFUND): study protocol
Butler, M., Bird, C., Maggio, C., Durden, A., Modlin, N. L., Campbell‐Coker, K., Edwards, M. J., Pick, S., Millman, L. S. M., Lowery, E., et al. (2024) · Wellcome Open Research · doi:10.12688/wellcomeopenres.22543.1 · Cited by 9
A framework for quality measurement in the presurgical care of chronic rhinosinusitis: a review from the Quality Improvement Committee of the American Rhinologic Society
Mattos, J. L., Soler, Z. M., Rudmik, L. R., Manes, P. R., Higgins, T. S., Lee, J. T., Schneider, J. S., Setzen, M., Parasher, A. K., Smith, T. L., et al. (2018) · International Forum of Allergy & Rhinology · doi:10.1002/alr.22154 · Cited by 9
Optimising treatment expectations in chronic lower back pain through observing others: a study protocol for a randomised clinical trial
Stuhlreyer, J., Schwartz, M., Friedheim, T., Zöllner, C., & Klinger, R. (2022) · BMJ Open · doi:10.1136/bmjopen-2021-059044 · Cited by 9
Conscious connected breathing with breath retention intervention in adults with chronic low back pain: protocol for a randomized controlled pilot study
Pratscher, S. D., Sibille, K. T., & Fillingim, R. B. (2023) · Pilot and Feasibility Studies · doi:10.1186/s40814-023-01247-9 · Cited by 9
Safety, feasibility, tolerability, and clinical effects of repeated psilocybin dosing combined with non-directive support in the treatment of obsessive-compulsive disorder: protocol for a randomized, waitlist-controlled trial with blinded ratings
Ching, T. H. W., Amoroso, L., Bohner, C., D’Amico, E. J., Eilbott, J. A., Entezar, T., Fitzpatrick, M., Fram, G., Grazioplene, R. G., Hokanson, J., et al. (2024) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2023.1278823 · Cited by 10
Prediction of duloxetine efficacy in addition to self‐management in painful temporomandibular disorders: A randomised, placebo‐controlled clinical trial
Ferreira, D. M. A. O., Soares, F. F. C., Raimundini, A. A., Bonjardim, L. R., Costa, Y. M., & Conti, P. C. R. (2023) · Journal of Oral Rehabilitation · doi:10.1111/joor.13628 · Cited by 6
Development of a text message-based headache diary in adolescents and children
Kellier, D. J., de Prado, B. M., Haagen, D., Grabner, P., Raj, N. R., Lechtenberg, L., Velasquez, G., Hsu, J. Y., Farrar, J. T., Hershey, A. D., et al. (2022) · Cephalalgia · doi:10.1177/03331024221090206 · Cited by 8
“This is a secondary analysis of data collected during follow-up from a validation study of a pediatric adaptation of the Stanford Expectations of Treatment Scale, a measure of a patient’s expectations of clinical outcome prior to the start of treatment (22).”
Method
A Psychometric Evaluation of the Stanford Expectations of Treatment Scale (SETS) in the Context of a Smoking Cessation Trial
Ferkin, A. C., Tonkin, S., Maguin, E., Mahoney, M. C., Colder, C. R., Tiffany, S. T., & Hawk, L. W. (2022) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntac187 · Cited by 8
Suggestions in Hypnosis to Aid Pain Education (SHAPE) in People with Chronic Low-Back Pain: A Pilot Feasibility Randomized, Controlled Trial
Pulling, B. W., Braithwaite, F. A., Moseley, G. L., Jensen, M. P., Burke, A. L. J., Collins, K. L., Hull, M. J., Jones, H. G., Cyna, A. M., Ferencz, N., et al. (2022) · International Journal of Clinical and Experimental Hypnosis · doi:10.1080/00207144.2022.2105147 · Cited by 8
“Treatment expectations (Stanford Expectations of Treatment Scale; Younger et al., 2012) were assessed at baseline and after the first treatment session.”
Background
A randomized, double-blind, placebo-controlled, hybrid parallel-arm study of low-dose naltrexone as an adjunctive anti-inflammatory treatment for major depressive disorder
Plank, J. R., Glover, S. C., Moloney, B. D., Hoeh, N. R., Sundram, F., Sumner, R. L., Muthukumaraswamy, S. D., & Lin, J. C. (2022) · Trials · doi:10.1186/s13063-022-06738-3 · Cited by 8
“Finally, the Generic Assessment of Side Effects (GASE, [51]) questionnaire will be used to monitor the adverse effects of LDN, and treatment expectancy effects will be measured using the Stanford Expectations of Treatment Scale (SETS, [52]).”
Method
Randomized controlled trial of intrathecal oxytocin on speed of recovery after hip arthroplasty
Eisenach, J. C., Shields, J. S., Weller, R. S., Curry, R. S., Langfitt, M. K., Henshaw, D. S., Pollock, D. C., Edwards, C. J., Collaborators, S. O. H. S., & Houle, T. T. (2022) · Pain · doi:10.1097/j.pain.0000000000002810 · Cited by 9
Psilocybin‐assisted psychotherapy for methamphetamine use disorder: A pilot open‐label safety and feasibility study.
Knock, E., Siefried, K. J., Bedi, G., Albert, S., Day, R. O., Ezard, N., Ross, M., Liknaitzky, P., & Brett, J. (2025) · Addiction · doi:10.1111/add.70187 · Cited by 9
Feasibility of Web-Based Single-Session Empowered Relief in Patients With Chronic Pain Taking Methadone or Buprenorphine: Protocol for a Single-Arm Trial
Klein, M. R., Darnall, B. D., & You, D. S. (2024) · JMIR Research Protocols · doi:10.2196/53784 · Cited by 7
“The 6-item Stanford Expectation of Treatment Scale [33] is administered to assess positive and negative expectation of upcoming treatment on an 11-point Likert scale ( α =.86).”
Method
Individualized frequency and montage tACS to engage theta-gamma coupling and enhance working memory in mild cognitive impairment
Mirjalili, M., Palamarchuk, I. S., Brooks, H., Zomorrodi, R., Melichercik, A., Wang, W., Nestor, S. M., Blumberger, D. M., Datta, A., Bowie, C. R., et al. (2025) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2025.1565881 · Cited by 8
5‐Methoxy‐ N , N ‐dimethyltryptamine (5‐MeO‐DMT) for alcohol use disorder: An open‐label, phase 2, proof‐of‐concept, clinical trial
Marsden, J., Kelleher, M., Dunbar, F., Ermakova, A. O., Mitcheson, L., Roberts, C., Rucker, J., Scott, G., Saeger, I., Small, F., et al. (2025) · Addiction · doi:10.1111/add.70260 · Cited by 7
Replicability of motor cortex-excitability modulation by intermittent theta burst stimulation
Seybert, C., Cotovio, G., da Silva, D. R., Viana, F. F., Pereira, P., & Oliveira-Maia, A. J. (2023) · Clinical Neurophysiology · doi:10.1016/j.clinph.2023.04.014 · Cited by 8
“Additionally, to assess participant expectation regarding the effects of TMS, we adapted the Stanford Expectation Treatment Scale (SETS) (Younger et al., 2012) to a Transcranial Magnetic Stimulation (TMS) research setting, according to International Test Commission Guidelines for Translating and Adapting Tests (ITC Gu…”
Method
A randomized sham-controlled trial of high-dosage accelerated intermittent theta burst rTMS in major depression: study protocol
Goodman, M. S., Vila‐Rodriguez, F., Barwick, M. A., Burke, M. J., Downar, J. H., Hunter, J., Kaster, T. S., Knyahnytska, Y., Kurdyak, P. A., Maunder, R., et al. (2024) · BMC Psychiatry · doi:10.1186/s12888-023-05470-9 · Cited by 8
“At baseline, participants will be asked about their expectancy of improving following the treatment course using the Stanford Expectancy Scale [41].”
Method
Effectiveness, cost-utility and implementation of a decision aid for patients with localised prostate cancer and their partners: study protocol of a stepped-wedge cluster randomised controlled trial
Al-Itejawi, H. H. M., van Uden‐Kraan, C. F., van de Ven, P. M., Coupé, V. M. H., Vis, A. N., Nieuwenhuijzen, J. A., van Moorselaar, R. J. A., & Leeuw, I. M. V. (2017) · BMJ Open · doi:10.1136/bmjopen-2016-015154 · Cited by 7
“Questions 7–10 are not scored and just provide optional information.(30)”
Background
Efficacy of the cognitive functional therapy (CFT) in patients with chronic nonspecific low back pain: a study protocol for a randomized sham-controlled trial
de Lira, M. R., Meziat‐Filho, N., Silva, G. Z. M., & Chaves, T. C. (2022) · Trials · doi:10.1186/s13063-022-06466-8 · Cited by 7
“In the baseline, we will administer scales to assess moderating effect: expectation [34], depression [35], anxiety [36], kinesiofobia [37], and pain catastrophizing [38].”
Method
Neurological and psychological mechanisms of the specific and nonspecific effects of acupuncture on knee osteoarthritis: study protocol for a randomized, controlled, crossover trial
Li, J., Liu, C., Zhang, N., Yan, C.-Q., Tu, J., Wang, Y., Qi, Y., Liu, J., & Wang, X. (2020) · Trials · doi:10.1186/s13063-020-04908-9 · Cited by 7
MDMA-Assisted Group Therapy for PTSD: Development of a Novel Protocol
Stauffer, C. S., Bouleh, P., & Anderson, B. T. (2025) · Cognitive and Behavioral Practice · doi:10.1016/j.cbpra.2025.03.001 · Cited by 7

Authors: Younger, J., Gandhi, V., Hubbard, E., & Mackey, S.
Affiliations: Stanford Medicine (US)
ORCID: Younger, Jarred
Hubbard, Emily
Mackey, Sean
Venue: Clinical Trials
Publisher: SAGE Publications
Published: 2012-11-20
Volume: 9
Issue: 6
Pages: 767-776
ISSN: 1740-7745 (ISSN-L)
1740-7753
DOI: 10.1177/1740774512465064
OpenAlex: W2020646491
Cited by: 212
References: 69
Citations by year: 2026: 27 · 2025: 33 · 2024: 24 · 2023: 23 · 2022: 26 · 2021: 21 · 2020: 14 · 2019: 10 · 2018: 15 · 2017: 8 · 2016: 5 · 2015: 3 · 2014: 2 · 2013: 1
FWCI: 0.98
Type: journal article
Language: en
Open access: closed
Licence: journals.sagepub.com/page/policies/text-and-data-mining-license (tdm)
Locations: Clinical Trials (publishedVersion)
PubMed (publishedVersion)
Funders: School of Medicine, Stanford University
Topics: Life Sciences › Neuroscience › Cognitive Neuroscience › Pain Management and Placebo Effect
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
Keywords: treatment expectancy, patient expectations, placebo effect, expectancy effects, scale development, psychometric validation, surgical treatment, pain interventions, statistical power
MeSH terms: Adult, Aged, Attitude to Health, Clinical Trials as Topic, Data Interpretation, Statistical, Factor Analysis, Statistical, Female, Humans, Male, Middle Aged, Predictive Value of Tests, Psychometrics, Surveys and Questionnaires, Research Design, Reproducibility of Results, Placebo Effect, Research Subjects

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Development of the Stanford Expectations of Treatment Scale (SETS): A tool for measuring patient outcome expectancy in clinical trials

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