Maintenance of Wellness in Patients with Obsessive-Compulsive Disorder Who Discontinue Medication after Exposure/Response Prevention Augmentation: A Randomized Clinical Trial

Edna B. Foa; Helen Blair Simpson; Thea Gallagher; Michael G. Wheaton; Marina Gershkovich; Andrew B. Schmidt; Jonathan D. Huppert; Patricia Imms; Raphael B. Campeas; Shawn Cahill; Christina Dichiara; Steven D. Tsao; Anthony Puliafico; Daniel Chazin; Anu Asnaani; Kelly Moore; Jeremy Tyler; Shari A. Steinman; Arturo Sanches-Lacay; Sandy Capaldi; Ívar Snorrason; Elizabeth Turk-Karan; Donna Vermes; Eyal Kalanthroff; Anthony Pinto; Gabriella E. Hamlett; Rachel Middleton; Chang Gyu Hahn; Bin Xu; Page E. Van Meter; Martha Katechis; David Rosenfield

doi:10.1001/jamapsychiatry.2021.3997

Maintenance of Wellness in Patients with Obsessive-Compulsive Disorder Who Discontinue Medication after Exposure/Response Prevention Augmentation: A Randomized Clinical Trial

Edna B. Foa^*, Helen Blair Simpson, Thea Gallagher, Michael G. Wheaton, Marina Gershkovich, Andrew B. Schmidt, Jonathan D. Huppert, Patricia Imms, Raphael B. Campeas, Shawn Cahill, Christina Dichiara, Steven D. Tsao, Anthony Puliafico, Daniel Chazin, Anu Asnaani, Kelly Moore, Jeremy Tyler, Shari A. Steinman, Arturo Sanches-Lacay, Sandy CapaldiÍvar Snorrason, Elizabeth Turk-Karan, Donna Vermes, Eyal Kalanthroff, Anthony Pinto, Gabriella E. Hamlett, Rachel Middleton, Chang Gyu Hahn, Bin Xu, Page E. Van Meter, Martha Katechis, David Rosenfield

^*Corresponding author for this work

Department of Psychology

Research output: Contribution to journal › Article › peer-review

7 Scopus citations

Abstract

Importance: Serotonin reuptake inhibitors (SRIs) are the only medications approved for obsessive-compulsive disorder (OCD), yet most patients taking SRIs exhibit significant symptoms. Adding exposure/response prevention (EX/RP) therapy improves symptoms, but it is unknown whether patients maintain wellness after discontinuing SRIs. Objective: To assess whether patients with OCD who are taking SRIs and have attained wellness after EX/RP augmentation can discontinue their SRI with noninferior outcomes compared with those who continue their SRI therapy. Design, Setting, and Participants: A 24-week, double-blind, randomized clinical trial was performed from May 3, 2013, to June 25, 2018. The trial took place at US academic medical centers. Participants included 137 adults with a principal diagnosis of OCD (≥1 year) who were taking an SRI (≥12 weeks), had at least moderate symptoms (defined as Yale-Brown Obsessive-Compulsive Scale [Y-BOCS] score ≥18 points), and received as many as 25 sessions of EX/RP therapy. Those who attained wellness (Y-BOCS score ≤14 points; 103 patients [75.2%]) were study eligible. Data were analyzed from June 29, 2019, to October 2, 2021. Intervention: Participants were randomly assigned either to receive taper to placebo (taper group) or to continue their SRI (continuation group) and monitored for 24 weeks. Main Outcome and Measures: The Y-BOCS score (range, 0-40 points) was the primary outcome; the Hamilton Depression Rating Scale (HDRS; range, 0-52 points) and the Quality-of-Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF; range, 0%-100%) scores were secondary outcomes. Outcomes were assessed at 8 time points by independent evaluators who were blinded to randomization. The taper regimen was hypothesized to be noninferior to continuation at 24 weeks using a 1-sided α value of.05. Results: A total of 101 patients (mean [SD] age, 31.0 [11.2] years; 55 women [54.5%]) participated in the trial: 51 patients (50.5%) in the taper group and 50 patients (49.5%) in the continuation group. At 24 weeks, patients in the taper group had noninferior results compared with patients in the continuation group (mean [SD] Y-BOCS score: taper group, 11.47 [6.56] points; continuation group: 11.51 [5.97] points; difference,-0.04 points; 1-sided 95% CI,-∞ to 2.09 points [below the noninferiority margin of 3.0 points]; mean [SD] HDRS score: taper group, 5.69 [3.84] points; continuation group, 4.61 [3.46] points; difference, 1.08 points; 1-sided 95% CI,-∞ to 2.28 points [below the noninferiority margin of 2.5 points]; mean [SD] Q-LES-Q-SF score: taper group, 68.01% [15.28%]; continuation group, 70.01% [15.59%]; difference, 2.00%; 1-sided 95% CI,-∞ to 6.83 [below the noninferiority margin of 7.75]). However, the taper group had higher rates of clinical worsening (23 of 51 [45%] vs 12 of 50 [24%]; P =.04). Conclusions and Relevance: Results of this randomized clinical trial show that patients with OCD who achieve wellness after EX/RP therapy could, on average, discontinue their SRI with noninferior outcomes compared with those who continued their SRI. Those who tapered the SRI had higher clinical worsening rates. Future research should evaluate if SRI half-life alters these rates. Trial Registration: ClinicalTrials.gov Identifier: NCT01686087.

Original language	American English
Pages (from-to)	193-200
Number of pages	8
Journal	JAMA Psychiatry
Volume	79
Issue number	3
DOIs	https://doi.org/10.1001/jamapsychiatry.2021.3997
State	Published - 1 Mar 2022

Bibliographical note

Funding Information:
receiving royalties from Bantam and Oxford University Press for book sales, including a manual of cognitive behavioral therapy for obsessive-compulsive disorder; receiving payment for training she conducts on treatment of obsessive-compulsive disorder; and receiving grants from the National Institutes of Health during the conduct of the study. Drs Foa and Simpson reported receiving research support from Biohaven Pharmaceuticals and royalties from Cambridge University Press and UpToDate, Inc, during the conduct of this study. Dr. Puliafico reported receiving royalties from UpToDate, Inc. Dr Rosenfield reported receiving stipends from JAMA Psychiatry and Behavior Research and Therapy for duties related to their editorial boards, receiving fees from Rosenfield Analytics for data analysis and statistical consulting, and receiving grants from the National Institutes of Health, the Department of Defense, and the Cancer Prevention and Research Institute of Texas for research outside the submitted work. No other disclosures were reported.

Funding Information:
Funding/Support: This work was supported by grant R01MH045404 (Dr Foa) and grant R01MH045436 (Dr Simpson) from the National Institute of Mental Health.

Publisher Copyright:
© 2022 American Medical Association. All rights reserved.

Keywords

Adult
Cognitive Behavioral Therapy/methods
Combined Modality Therapy
Female
Humans
Implosive Therapy
Male
Obsessive-Compulsive Disorder/diagnosis
Serotonin Uptake Inhibitors/therapeutic use
Treatment Outcome

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1001/jamapsychiatry.2021.3997

Cite this

Foa, E. B., Simpson, H. B., Gallagher, T., Wheaton, M. G., Gershkovich, M., Schmidt, A. B., Huppert, J. D., Imms, P., Campeas, R. B., Cahill, S., Dichiara, C., Tsao, S. D., Puliafico, A., Chazin, D., Asnaani, A., Moore, K., Tyler, J., Steinman, S. A., Sanches-Lacay, A., ... Rosenfield, D. (2022). Maintenance of Wellness in Patients with Obsessive-Compulsive Disorder Who Discontinue Medication after Exposure/Response Prevention Augmentation: A Randomized Clinical Trial. JAMA Psychiatry, 79(3), 193-200. https://doi.org/10.1001/jamapsychiatry.2021.3997

@article{199f7f09642647e19df4581224c61d44,

title = "Maintenance of Wellness in Patients with Obsessive-Compulsive Disorder Who Discontinue Medication after Exposure/Response Prevention Augmentation: A Randomized Clinical Trial",

abstract = "Importance: Serotonin reuptake inhibitors (SRIs) are the only medications approved for obsessive-compulsive disorder (OCD), yet most patients taking SRIs exhibit significant symptoms. Adding exposure/response prevention (EX/RP) therapy improves symptoms, but it is unknown whether patients maintain wellness after discontinuing SRIs. Objective: To assess whether patients with OCD who are taking SRIs and have attained wellness after EX/RP augmentation can discontinue their SRI with noninferior outcomes compared with those who continue their SRI therapy. Design, Setting, and Participants: A 24-week, double-blind, randomized clinical trial was performed from May 3, 2013, to June 25, 2018. The trial took place at US academic medical centers. Participants included 137 adults with a principal diagnosis of OCD (≥1 year) who were taking an SRI (≥12 weeks), had at least moderate symptoms (defined as Yale-Brown Obsessive-Compulsive Scale [Y-BOCS] score ≥18 points), and received as many as 25 sessions of EX/RP therapy. Those who attained wellness (Y-BOCS score ≤14 points; 103 patients [75.2%]) were study eligible. Data were analyzed from June 29, 2019, to October 2, 2021. Intervention: Participants were randomly assigned either to receive taper to placebo (taper group) or to continue their SRI (continuation group) and monitored for 24 weeks. Main Outcome and Measures: The Y-BOCS score (range, 0-40 points) was the primary outcome; the Hamilton Depression Rating Scale (HDRS; range, 0-52 points) and the Quality-of-Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF; range, 0%-100%) scores were secondary outcomes. Outcomes were assessed at 8 time points by independent evaluators who were blinded to randomization. The taper regimen was hypothesized to be noninferior to continuation at 24 weeks using a 1-sided α value of.05. Results: A total of 101 patients (mean [SD] age, 31.0 [11.2] years; 55 women [54.5%]) participated in the trial: 51 patients (50.5%) in the taper group and 50 patients (49.5%) in the continuation group. At 24 weeks, patients in the taper group had noninferior results compared with patients in the continuation group (mean [SD] Y-BOCS score: taper group, 11.47 [6.56] points; continuation group: 11.51 [5.97] points; difference,-0.04 points; 1-sided 95% CI,-∞ to 2.09 points [below the noninferiority margin of 3.0 points]; mean [SD] HDRS score: taper group, 5.69 [3.84] points; continuation group, 4.61 [3.46] points; difference, 1.08 points; 1-sided 95% CI,-∞ to 2.28 points [below the noninferiority margin of 2.5 points]; mean [SD] Q-LES-Q-SF score: taper group, 68.01% [15.28%]; continuation group, 70.01% [15.59%]; difference, 2.00%; 1-sided 95% CI,-∞ to 6.83 [below the noninferiority margin of 7.75]). However, the taper group had higher rates of clinical worsening (23 of 51 [45%] vs 12 of 50 [24%]; P =.04). Conclusions and Relevance: Results of this randomized clinical trial show that patients with OCD who achieve wellness after EX/RP therapy could, on average, discontinue their SRI with noninferior outcomes compared with those who continued their SRI. Those who tapered the SRI had higher clinical worsening rates. Future research should evaluate if SRI half-life alters these rates. Trial Registration: ClinicalTrials.gov Identifier: NCT01686087.",

keywords = "Adult, Cognitive Behavioral Therapy/methods, Combined Modality Therapy, Female, Humans, Implosive Therapy, Male, Obsessive-Compulsive Disorder/diagnosis, Serotonin Uptake Inhibitors/therapeutic use, Treatment Outcome",

author = "Foa, {Edna B.} and Simpson, {Helen Blair} and Thea Gallagher and Wheaton, {Michael G.} and Marina Gershkovich and Schmidt, {Andrew B.} and Huppert, {Jonathan D.} and Patricia Imms and Campeas, {Raphael B.} and Shawn Cahill and Christina Dichiara and Tsao, {Steven D.} and Anthony Puliafico and Daniel Chazin and Anu Asnaani and Kelly Moore and Jeremy Tyler and Steinman, {Shari A.} and Arturo Sanches-Lacay and Sandy Capaldi and {\'I}var Snorrason and Elizabeth Turk-Karan and Donna Vermes and Eyal Kalanthroff and Anthony Pinto and Hamlett, {Gabriella E.} and Rachel Middleton and Hahn, {Chang Gyu} and Bin Xu and {Van Meter}, {Page E.} and Martha Katechis and David Rosenfield",

note = "Funding Information: receiving royalties from Bantam and Oxford University Press for book sales, including a manual of cognitive behavioral therapy for obsessive-compulsive disorder; receiving payment for training she conducts on treatment of obsessive-compulsive disorder; and receiving grants from the National Institutes of Health during the conduct of the study. Drs Foa and Simpson reported receiving research support from Biohaven Pharmaceuticals and royalties from Cambridge University Press and UpToDate, Inc, during the conduct of this study. Dr. Puliafico reported receiving royalties from UpToDate, Inc. Dr Rosenfield reported receiving stipends from JAMA Psychiatry and Behavior Research and Therapy for duties related to their editorial boards, receiving fees from Rosenfield Analytics for data analysis and statistical consulting, and receiving grants from the National Institutes of Health, the Department of Defense, and the Cancer Prevention and Research Institute of Texas for research outside the submitted work. No other disclosures were reported. Funding Information: Funding/Support: This work was supported by grant R01MH045404 (Dr Foa) and grant R01MH045436 (Dr Simpson) from the National Institute of Mental Health. Publisher Copyright: {\textcopyright} 2022 American Medical Association. All rights reserved.",

year = "2022",

month = mar,

day = "1",

doi = "10.1001/jamapsychiatry.2021.3997",

language = "American English",

volume = "79",

pages = "193--200",

journal = "JAMA Psychiatry",

issn = "2168-622X",

publisher = "American Medical Association",

number = "3",

}

Foa, EB, Simpson, HB, Gallagher, T, Wheaton, MG, Gershkovich, M, Schmidt, AB, Huppert, JD, Imms, P, Campeas, RB, Cahill, S, Dichiara, C, Tsao, SD, Puliafico, A, Chazin, D, Asnaani, A, Moore, K, Tyler, J, Steinman, SA, Sanches-Lacay, A, Capaldi, S, Snorrason, Í, Turk-Karan, E, Vermes, D, Kalanthroff, E, Pinto, A, Hamlett, GE, Middleton, R, Hahn, CG, Xu, B, Van Meter, PE, Katechis, M & Rosenfield, D 2022, 'Maintenance of Wellness in Patients with Obsessive-Compulsive Disorder Who Discontinue Medication after Exposure/Response Prevention Augmentation: A Randomized Clinical Trial', JAMA Psychiatry, vol. 79, no. 3, pp. 193-200. https://doi.org/10.1001/jamapsychiatry.2021.3997

TY - JOUR

T1 - Maintenance of Wellness in Patients with Obsessive-Compulsive Disorder Who Discontinue Medication after Exposure/Response Prevention Augmentation

T2 - A Randomized Clinical Trial

AU - Foa, Edna B.

AU - Simpson, Helen Blair

AU - Gallagher, Thea

AU - Wheaton, Michael G.

AU - Gershkovich, Marina

AU - Schmidt, Andrew B.

AU - Huppert, Jonathan D.

AU - Imms, Patricia

AU - Campeas, Raphael B.

AU - Cahill, Shawn

AU - Dichiara, Christina

AU - Tsao, Steven D.

AU - Puliafico, Anthony

AU - Chazin, Daniel

AU - Asnaani, Anu

AU - Moore, Kelly

AU - Tyler, Jeremy

AU - Steinman, Shari A.

AU - Sanches-Lacay, Arturo

AU - Capaldi, Sandy

AU - Snorrason, Ívar

AU - Turk-Karan, Elizabeth

AU - Vermes, Donna

AU - Kalanthroff, Eyal

AU - Pinto, Anthony

AU - Hamlett, Gabriella E.

AU - Middleton, Rachel

AU - Hahn, Chang Gyu

AU - Xu, Bin

AU - Van Meter, Page E.

AU - Katechis, Martha

AU - Rosenfield, David

N1 - Funding Information: receiving royalties from Bantam and Oxford University Press for book sales, including a manual of cognitive behavioral therapy for obsessive-compulsive disorder; receiving payment for training she conducts on treatment of obsessive-compulsive disorder; and receiving grants from the National Institutes of Health during the conduct of the study. Drs Foa and Simpson reported receiving research support from Biohaven Pharmaceuticals and royalties from Cambridge University Press and UpToDate, Inc, during the conduct of this study. Dr. Puliafico reported receiving royalties from UpToDate, Inc. Dr Rosenfield reported receiving stipends from JAMA Psychiatry and Behavior Research and Therapy for duties related to their editorial boards, receiving fees from Rosenfield Analytics for data analysis and statistical consulting, and receiving grants from the National Institutes of Health, the Department of Defense, and the Cancer Prevention and Research Institute of Texas for research outside the submitted work. No other disclosures were reported. Funding Information: Funding/Support: This work was supported by grant R01MH045404 (Dr Foa) and grant R01MH045436 (Dr Simpson) from the National Institute of Mental Health. Publisher Copyright: © 2022 American Medical Association. All rights reserved.

PY - 2022/3/1

Y1 - 2022/3/1

N2 - Importance: Serotonin reuptake inhibitors (SRIs) are the only medications approved for obsessive-compulsive disorder (OCD), yet most patients taking SRIs exhibit significant symptoms. Adding exposure/response prevention (EX/RP) therapy improves symptoms, but it is unknown whether patients maintain wellness after discontinuing SRIs. Objective: To assess whether patients with OCD who are taking SRIs and have attained wellness after EX/RP augmentation can discontinue their SRI with noninferior outcomes compared with those who continue their SRI therapy. Design, Setting, and Participants: A 24-week, double-blind, randomized clinical trial was performed from May 3, 2013, to June 25, 2018. The trial took place at US academic medical centers. Participants included 137 adults with a principal diagnosis of OCD (≥1 year) who were taking an SRI (≥12 weeks), had at least moderate symptoms (defined as Yale-Brown Obsessive-Compulsive Scale [Y-BOCS] score ≥18 points), and received as many as 25 sessions of EX/RP therapy. Those who attained wellness (Y-BOCS score ≤14 points; 103 patients [75.2%]) were study eligible. Data were analyzed from June 29, 2019, to October 2, 2021. Intervention: Participants were randomly assigned either to receive taper to placebo (taper group) or to continue their SRI (continuation group) and monitored for 24 weeks. Main Outcome and Measures: The Y-BOCS score (range, 0-40 points) was the primary outcome; the Hamilton Depression Rating Scale (HDRS; range, 0-52 points) and the Quality-of-Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF; range, 0%-100%) scores were secondary outcomes. Outcomes were assessed at 8 time points by independent evaluators who were blinded to randomization. The taper regimen was hypothesized to be noninferior to continuation at 24 weeks using a 1-sided α value of.05. Results: A total of 101 patients (mean [SD] age, 31.0 [11.2] years; 55 women [54.5%]) participated in the trial: 51 patients (50.5%) in the taper group and 50 patients (49.5%) in the continuation group. At 24 weeks, patients in the taper group had noninferior results compared with patients in the continuation group (mean [SD] Y-BOCS score: taper group, 11.47 [6.56] points; continuation group: 11.51 [5.97] points; difference,-0.04 points; 1-sided 95% CI,-∞ to 2.09 points [below the noninferiority margin of 3.0 points]; mean [SD] HDRS score: taper group, 5.69 [3.84] points; continuation group, 4.61 [3.46] points; difference, 1.08 points; 1-sided 95% CI,-∞ to 2.28 points [below the noninferiority margin of 2.5 points]; mean [SD] Q-LES-Q-SF score: taper group, 68.01% [15.28%]; continuation group, 70.01% [15.59%]; difference, 2.00%; 1-sided 95% CI,-∞ to 6.83 [below the noninferiority margin of 7.75]). However, the taper group had higher rates of clinical worsening (23 of 51 [45%] vs 12 of 50 [24%]; P =.04). Conclusions and Relevance: Results of this randomized clinical trial show that patients with OCD who achieve wellness after EX/RP therapy could, on average, discontinue their SRI with noninferior outcomes compared with those who continued their SRI. Those who tapered the SRI had higher clinical worsening rates. Future research should evaluate if SRI half-life alters these rates. Trial Registration: ClinicalTrials.gov Identifier: NCT01686087.

AB - Importance: Serotonin reuptake inhibitors (SRIs) are the only medications approved for obsessive-compulsive disorder (OCD), yet most patients taking SRIs exhibit significant symptoms. Adding exposure/response prevention (EX/RP) therapy improves symptoms, but it is unknown whether patients maintain wellness after discontinuing SRIs. Objective: To assess whether patients with OCD who are taking SRIs and have attained wellness after EX/RP augmentation can discontinue their SRI with noninferior outcomes compared with those who continue their SRI therapy. Design, Setting, and Participants: A 24-week, double-blind, randomized clinical trial was performed from May 3, 2013, to June 25, 2018. The trial took place at US academic medical centers. Participants included 137 adults with a principal diagnosis of OCD (≥1 year) who were taking an SRI (≥12 weeks), had at least moderate symptoms (defined as Yale-Brown Obsessive-Compulsive Scale [Y-BOCS] score ≥18 points), and received as many as 25 sessions of EX/RP therapy. Those who attained wellness (Y-BOCS score ≤14 points; 103 patients [75.2%]) were study eligible. Data were analyzed from June 29, 2019, to October 2, 2021. Intervention: Participants were randomly assigned either to receive taper to placebo (taper group) or to continue their SRI (continuation group) and monitored for 24 weeks. Main Outcome and Measures: The Y-BOCS score (range, 0-40 points) was the primary outcome; the Hamilton Depression Rating Scale (HDRS; range, 0-52 points) and the Quality-of-Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF; range, 0%-100%) scores were secondary outcomes. Outcomes were assessed at 8 time points by independent evaluators who were blinded to randomization. The taper regimen was hypothesized to be noninferior to continuation at 24 weeks using a 1-sided α value of.05. Results: A total of 101 patients (mean [SD] age, 31.0 [11.2] years; 55 women [54.5%]) participated in the trial: 51 patients (50.5%) in the taper group and 50 patients (49.5%) in the continuation group. At 24 weeks, patients in the taper group had noninferior results compared with patients in the continuation group (mean [SD] Y-BOCS score: taper group, 11.47 [6.56] points; continuation group: 11.51 [5.97] points; difference,-0.04 points; 1-sided 95% CI,-∞ to 2.09 points [below the noninferiority margin of 3.0 points]; mean [SD] HDRS score: taper group, 5.69 [3.84] points; continuation group, 4.61 [3.46] points; difference, 1.08 points; 1-sided 95% CI,-∞ to 2.28 points [below the noninferiority margin of 2.5 points]; mean [SD] Q-LES-Q-SF score: taper group, 68.01% [15.28%]; continuation group, 70.01% [15.59%]; difference, 2.00%; 1-sided 95% CI,-∞ to 6.83 [below the noninferiority margin of 7.75]). However, the taper group had higher rates of clinical worsening (23 of 51 [45%] vs 12 of 50 [24%]; P =.04). Conclusions and Relevance: Results of this randomized clinical trial show that patients with OCD who achieve wellness after EX/RP therapy could, on average, discontinue their SRI with noninferior outcomes compared with those who continued their SRI. Those who tapered the SRI had higher clinical worsening rates. Future research should evaluate if SRI half-life alters these rates. Trial Registration: ClinicalTrials.gov Identifier: NCT01686087.

KW - Adult

KW - Cognitive Behavioral Therapy/methods

KW - Combined Modality Therapy

KW - Female

KW - Humans

KW - Implosive Therapy

KW - Male

KW - Obsessive-Compulsive Disorder/diagnosis

KW - Serotonin Uptake Inhibitors/therapeutic use

KW - Treatment Outcome

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U2 - 10.1001/jamapsychiatry.2021.3997

DO - 10.1001/jamapsychiatry.2021.3997

M3 - Article

C2 - 35080598

AN - SCOPUS:85124144973

SN - 2168-622X

VL - 79

SP - 193

EP - 200

JO - JAMA Psychiatry

JF - JAMA Psychiatry

IS - 3

ER -

Maintenance of Wellness in Patients with Obsessive-Compulsive Disorder Who Discontinue Medication after Exposure/Response Prevention Augmentation: A Randomized Clinical Trial

Abstract

Bibliographical note

Keywords

UN SDGs

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