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CompletedNCT02378714Updated Jul 29, 2021Results posted

Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers

A Phase 4 interventional study of Varenicline and BASC in Nicotine Dependence and Major Depressive Disorder, sponsored by Northwestern University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-29.

Sponsored by Northwestern University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Persons who struggle with depression smoke at high rates and experience low quit rates in treatment. The best way to improve cessation treatment for this underserved population remains unknown. The proposed trial tests whether the combination of varenicline and behavioral mood management treatment enhances long-term abstinence for depressed smokers and, if so, whether this treatment achieves its effects through addressing the unique psychological factors that appear to maintain tobacco dependence for these smokers.

Read the detailed description

Upwards of 43% of persons with major depressive disorder (MDD) are daily smokers who are more likely to smoke heavily, show greater tobacco dependence, suffer more severe withdrawal, and experience lower quit rates than smokers without MDD. Little is known about treatment strategies that might optimize smoking cessation for smokers with MDD because almost all randomized clinical trials have excluded these smokers. This project answers many prominent but largely unanswered calls over the last decade to address tobacco dependence in persons with mental health disorders, especially major depressive disorder (MDD). Using a double-blind, placebo-controlled, randomized design, the investigators will evaluate the efficacy of behavioral activation for smoking cessation (BASC) plus varenicline for treating tobacco dependence in smokers with current or lifetime MDD. Three hundred and thirty daily (≥1 cigarettes/day) smokers will be randomized to receive 12 weeks of one of four treatments: 1) Standard behavioral cessation treatment (ST) + placebo; 2) Behavioral activation integrated with ST (BASC) + placebo; 3) ST + varenicline; or 4) BASC + varenicline. Both BASC and ST will be administered in eight 45 minute sessions, occurring weekly for the first four weeks and biweekly for the final eight weeks. Randomization will be stratified on clinical site (Northwestern, University of Pennsylvania), gender, and severity of depressive symptoms (minimal/mild vs. moderate/severe). The primary outcomes will be carbon monoxide (CO) verified 7-day point prevalence abstinence at 24-weeks post-quit. Additional aims include assessing adverse event rates between varenicline and placebo arms, and testing for mediation of treatment effects by anhedonia, cognitive function (attention and memory), cigarette reward value, and craving and withdrawal. This randomized controlled trial will be the first adequately powered trial of BASC in this population; the first trial to evaluate varenicline among a community sample of smokers with MDD; and the first trial to assess the main and combined effects of these two treatments.

02

Conditions studied

  • Nicotine Dependence
  • Major Depressive Disorder

Keywords

  • Smoking Cessation
  • Major Depressive Disorder
  • Nicotine Dependence
  • Varenicline
  • Behavioral Activation Therapy
  • Cigarette Smoking
03

In context

Tobacco Use Disorder

968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.

This study's enrollment of 300 is above the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.

Browse Tobacco Use Disorder studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. adult (18 years of age or older) daily cigarette smokers (1+ cigarettes per day)
  2. meet criteria for current or lifetime MDD without psychotic features
  3. have or are willing to acquire a personal email address and access to a camera phone or other method for submission of therapy practice assignments
  4. speak, read, and write fluently in English
  5. able to provide written informed consent
  6. intend to reside in the geographic area for >8 months
  7. women of childbearing potential must agree to use a medically acceptable method of birth control or abstain from sexual intercourse during the time they are taking study medication and for at least one month after the medication period ends.
  8. The candidate had to answer "yes" to the question: "Are you interested in quitting smoking?"

Exclusion criteria

Exclusion criteria:

  1. current enrollment or plan to enroll in another smoking cessation program in the next 8 months
  2. regular (daily) use of e-cigarettes, chewing tobacco, snuff, snus, or other tobacco products
  3. current use or plan to use nicotine replacement therapy or other smoking cessation medication within the next 8 months
  4. medications indicated for bipolar or psychotic disorder if prescribed for bipolar or psychotic disorder
  5. pregnant or planning to become pregnant within the next 8 months, or breast feeding
  6. history of seizures or current seizure disorder without medication
  7. history of severe (stage IV or V) chronic kidney disease including current or prior end stage renal disease on either hemodialysis or peritoneal dialysis or prior renal transplant
  8. any prior solid organ transplant or prior hematopoietic stem cell transplant
  9. alcohol consumption exceeding 28 drinks per week
  10. cirrhosis or end-stage liver disease
  11. systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg after two readings or symptomatic uncontrolled stage II hypertension
  12. unstable cardiovascular disease within 3 months prior to baseline or other cardiovascular disease requiring hospitalization
  13. prior hospitalization for heart failure
  14. previous allergic reaction to varenicline
  15. high suicide risk based on the Columbia Suicide Severity Rating Scale
  16. lifetime bipolar or psychotic disorder as determined by either self-report or clinical interview
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
300 participants (actual)

Study arms

  • Placebo comparator
    Standard treatment + placebo varenicline

    Standard behavioral smoking cessation treatment plus placebo varenicline

    Behavioral: Standard treatment

  • Experimental
    BASC + placebo varenicline

    Behavioral activation for smoking cessation plus placebo varenicline

    Behavioral: BASC

  • Active comparator
    Standard treatment + active varenicline

    Standard behavioral smoking cessation treatment plus active varenicline

    Drug: Varenicline · Behavioral: Standard treatment

  • Experimental
    BASC + active varenicline

    Behavioral activation for smoking cessation plus active varenicline

    Drug: Varenicline · Behavioral: BASC

Interventions

  • DrugVarenicline

    Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.

    Also known as: Chantix

  • BehavioralBASC

    The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.

    Also known as: Behavioral activation for smoking cessation

  • BehavioralStandard treatment

    Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.

    Also known as: Standard Therapy

06

What researchers measure

Primary outcomes

  1. Bioverified Point-prevalence Abstinence at 27 Weeks

    Participants were classified as abstinent if they reported abstinence, not even a puff of a cigarette, for \>7 days prior to week 27 (24 weeks post-target quit date) and had an expired carbon monoxide reading of ≤ 6 parts per million at week 27.

    Time frame: 27 weeks (24-weeks post-target quit date)

  2. Adverse Event and Serious Adverse Event Rates

    Adverse event and serious adverse event rates between varenicline and placebo arms. A previously developed algorithm was used to classify side effect reports as adverse events (AEs) or serious adverse events (SAEs) (Schnoll et al. 2019). Reference: Schnoll, R., Leone, F., Weisbrot, J., Veluz-Wilkins, A., Miele, A., Hole, A., Jao, N.C., Wileyto, E.P., Carroll, A.J., Kalhan, R., Patel, J., Langer, C., \& Hitsman, B. (2019). A randomized controlled trial of 24-weeks of varenicline for tobacco use among cancer patients: Efficacy, safety, and adherence. Psycho-Oncology, 28, 561-569.

    Time frame: Weeks 1 (1-week before starting medication), 6, and 14 (end of medication)

Secondary outcomes

  1. Bioverified Point-prevalence Abstinence at 14 Weeks (End of Treatment)

    Participants were classified as abstinent if they reported abstinence, not even a puff of a cigarette, for \>7 days prior to week 14 (11-weeks post-target quit date) and had an expired carbon monoxide reading of ≤ 6 parts per million at week 14.

    Time frame: 14 weeks (11-weeks post-target quit date)

  2. Prolonged Abstinence

    \<7 consecutive days of self-reported smoking after a 2-week grace period

    Time frame: 27 weeks (24 weeks post target quit date)

  3. Continuous Abstinence

    No smoking between target quit date (week 3) and week 27

    Time frame: 27 weeks (24 weeks post target quit date)

  4. Time to 7-day Relapse

    Time to relapse as defined by 7 or more consecutive days of self-reported smoking (no grace period)

    Time frame: 27 weeks (24 weeks post target quit date)

07

Results

Posted May 27, 2021

Participant flow

Participant flow — Overall Study
MilestoneStandard Treatment + Placebo VareniclineBASC + Placebo VareniclineStandard Treatment + Active VareniclineBASC + Active Varenicline
Started68688183
Completed39295151
Not completed29393032

Outcome measures

PrimaryBioverified Point-prevalence Abstinence at 27 Weeks

Participants were classified as abstinent if they reported abstinence, not even a puff of a cigarette, for \>7 days prior to week 27 (24 weeks post-target quit date) and had an expired carbon monoxide reading of ≤ 6 parts per million at week 27.

Time frame:
27 weeks (24-weeks post-target quit date)
Reported as:
Count of participants · Participants
Bioverified Point-prevalence Abstinence at 27 Weeks
ParticipantsStandard Treatment + Placebo VareniclineBASC + Placebo VareniclineStandard Treatment + Active VareniclineBASC + Active Varenicline
Bioverified Point-prevalence Abstinence at 27 Weeks631313
PrimaryAdverse Event and Serious Adverse Event Rates

Adverse event and serious adverse event rates between varenicline and placebo arms. A previously developed algorithm was used to classify side effect reports as adverse events (AEs) or serious adverse events (SAEs) (Schnoll et al. 2019). Reference: Schnoll, R., Leone, F., Weisbrot, J., Veluz-Wilkins, A., Miele, A., Hole, A., Jao, N.C., Wileyto, E.P., Carroll, A.J., Kalhan, R., Patel, J., Langer, C., \& Hitsman, B. (2019). A randomized controlled trial of 24-weeks of varenicline for tobacco use among cancer patients: Efficacy, safety, and adherence. Psycho-Oncology, 28, 561-569.

Time frame:
Weeks 1 (1-week before starting medication), 6, and 14 (end of medication)
Reported as:
Count of participants · Participants
Adverse Event and Serious Adverse Event Rates
ParticipantsPlacebo - Week 1Varenicline - Week 1Placebo - Week 6Varenicline - Week 6Placebo - Week 14Varenicline - Week 14
Any adverse event10413668815060
Any serious adverse event2834262298
SecondaryBioverified Point-prevalence Abstinence at 14 Weeks (End of Treatment)

Participants were classified as abstinent if they reported abstinence, not even a puff of a cigarette, for \>7 days prior to week 14 (11-weeks post-target quit date) and had an expired carbon monoxide reading of ≤ 6 parts per million at week 14.

Time frame:
14 weeks (11-weeks post-target quit date)
Reported as:
Count of participants · Participants
Bioverified Point-prevalence Abstinence at 14 Weeks (End of Treatment)
ParticipantsStandard Treatment + Placebo VareniclineBASC + Placebo VareniclineStandard Treatment + Active VareniclineBASC + Active Varenicline
Bioverified Point-prevalence Abstinence at 14 Weeks (End of Treatment)842626
SecondaryProlonged Abstinence

\<7 consecutive days of self-reported smoking after a 2-week grace period

Time frame:
27 weeks (24 weeks post target quit date)
Reported as:
Count of participants · Participants
Prolonged Abstinence
ParticipantsStandard Treatment + Placebo VareniclineBASC + Placebo VareniclineStandard Treatment + Active VareniclineBASC + Active Varenicline
Prolonged Abstinence13112626
SecondaryContinuous Abstinence

No smoking between target quit date (week 3) and week 27

Time frame:
27 weeks (24 weeks post target quit date)
Reported as:
Count of participants · Participants
Continuous Abstinence
ParticipantsStandard Treatment + Placebo VareniclineBASC + Placebo VareniclineStandard Treatment + Active VareniclineBASC + Active Varenicline
Continuous Abstinence3262
SecondaryTime to 7-day Relapse

Time to relapse as defined by 7 or more consecutive days of self-reported smoking (no grace period)

Time frame:
27 weeks (24 weeks post target quit date)
Reported as:
Median · median days to relapse
Time to 7-day Relapse
median days to relapseStandard Treatment + Placebo VareniclineBASC + Placebo VareniclineStandard Treatment + Active VareniclineBASC + Active Varenicline
Time to 7-day Relapse15 (15 to 16)15 (15 to 22)57 (15 to 144)24 (15 to 135)

Adverse events

Collected over Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo - Week 10/136 (0%)28/136 (20.6%)104/136 (76.5%)
Varenicline - Week 10/164 (0%)34/164 (20.7%)136/164 (82.9%)
Placebo - Week 30/114 (0%)24/114 (21.1%)90/114 (78.9%)
Varenicline - Week 30/137 (0%)29/137 (21.2%)103/137 (75.2%)
Placebo - Week 40/100 (0%)21/100 (21%)80/100 (80%)
Varenicline - Week 40/120 (0%)19/120 (15.8%)93/120 (77.5%)
Placebo - Week 60/91 (0%)26/91 (28.6%)68/91 (74.7%)
Varenicline - Week 60/121 (0%)22/121 (18.2%)81/121 (66.9%)
Placebo - Week 70/85 (0%)18/85 (21.2%)65/85 (76.5%)
Varenicline - Week 70/119 (0%)18/119 (15.1%)77/119 (64.7%)
Placebo - Week 80/80 (0%)15/80 (18.8%)57/80 (71.3%)
Varenicline - Week 80/115 (0%)14/115 (12.2%)71/115 (61.7%)
Placebo - Week 100/79 (0%)15/79 (19%)51/79 (64.6%)
Varenicline - Week 100/113 (0%)18/113 (15.9%)71/113 (62.8%)
Placebo - Week 120/79 (0%)12/79 (15.2%)52/79 (65.8%)
Varenicline - Week 120/109 (0%)12/109 (11%)63/109 (57.8%)
Placebo - Week 140/74 (0%)9/74 (12.2%)50/74 (67.6%)
Varenicline - Week 140/104 (0%)8/104 (7.7%)60/104 (57.7%)
Placebo - Week 270/68 (0%)10/68 (14.7%)37/68 (54.4%)
Varenicline - Week 270/102 (0%)12/102 (11.8%)55/102 (53.9%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventPlacebo - Week 1Varenicline - Week 1Placebo - Week 3Varenicline - Week 3Placebo - Week 4Varenicline - Week 4Placebo - Week 6Varenicline - Week 6Placebo - Week 7Varenicline - Week 7Placebo - Week 8Varenicline - Week 8Placebo - Week 10Varenicline - Week 10Placebo - Week 12Varenicline - Week 12Placebo - Week 14Varenicline - Week 14Placebo - Week 27Varenicline - Week 27
AgitationPsychiatric disorders20/13619/16410/11416/13712/10010/12012/919/12110/8511/1197/8010/1158/7910/1139/797/1095/747/1048/684/102
Suicidal thoughts or i deationPsychiatric disorders4/13615/1646/1148/1373/1006/1209/916/1215/857/1195/804/1153/795/1133/792/1093/741/1041/685/102
HostilityPsychiatric disorders6/1368/1645/1142/1378/1004/1204/915/1216/854/1197/803/1155/795/1134/795/1094/743/1041/683/102
IrritabilityPsychiatric disorders4/1361/1643/1143/1374/1003/1205/914/1213/853/1192/801/1152/795/1131/791/1092/742/1042/681/102
Depressed MoodPsychiatric disorders3/1363/1643/1144/1372/1004/1201/916/1211/854/1194/804/1150/792/1130/794/1091/742/1040/680/102
AnxietyPsychiatric disorders5/1363/1641/1143/1371/1004/1202/915/1211/853/1192/801/1153/793/1133/792/1090/741/1041/681/102
Weakness on one or both sides of the bodyGeneral disorders1/1361/1640/1141/1373/1000/1202/912/1211/850/1190/801/1150/791/1130/790/1091/740/1040/681/102
NauseaGeneral disorders0/1361/1642/1143/1370/1000/1202/911/1210/852/1190/800/1151/793/1131/790/1090/740/1041/681/102
Abdominal PainGastrointestinal disorders0/1360/1642/1142/1371/1000/1201/910/1210/851/1190/800/1150/793/1130/791/1090/741/1040/680/102
HeadacheGeneral disorders1/1363/1642/1141/1370/1001/1201/913/1210/852/1191/801/1150/792/1131/792/1091/742/1040/681/102
Most frequent other events
Showing 10 of 27
Most frequent other events
EventPlacebo - Week 1Varenicline - Week 1Placebo - Week 3Varenicline - Week 3Placebo - Week 4Varenicline - Week 4Placebo - Week 6Varenicline - Week 6Placebo - Week 7Varenicline - Week 7Placebo - Week 8Varenicline - Week 8Placebo - Week 10Varenicline - Week 10Placebo - Week 12Varenicline - Week 12Placebo - Week 14Varenicline - Week 14Placebo - Week 27Varenicline - Week 27
AnxietyPsychiatric disorders67/13676/16457/11455/13750/10043/12042/9142/12139/8542/11941/8039/11533/7931/11330/7933/10932/7427/10425/6830/102
Sleep problemsPsychiatric disorders36/13661/16423/11432/13716/10023/12020/9113/12114/8521/11917/8022/1158/7914/1138/7913/1097/7413/1048/6810/102
AgitationPsychiatric disorders33/13644/16429/11430/13731/10034/12023/9129/12120/8528/11921/8020/11524/7917/11320/7919/10921/7417/10414/6820/102
Depressed MoodPsychiatric disorders37/13641/16415/11421/13719/10016/1209/9114/12113/8517/1198/8016/11515/7915/11310/796/1097/747/1049/6815/102
Fatigue/lethargyGeneral disorders36/13641/16420/11420/13718/10023/12015/9118/12115/8513/1197/8017/11512/7913/1137/7912/1099/7411/1046/6810/102
Abdominal PainGastrointestinal disorders21/13623/16413/11428/13714/10028/12015/9124/12114/8521/11912/8021/11512/7921/11315/7915/10913/7411/1048/6817/102
InsomniaPsychiatric disorders21/13637/16412/11420/13712/10010/12010/9114/12112/8511/1198/8012/1157/798/11310/795/1097/747/1048/688/102
IrritabilityPsychiatric disorders16/13630/16411/11414/13712/10015/1208/9116/12111/8510/11912/8014/11511/7910/1136/798/1097/746/1043/687/102
HostilityPsychiatric disorders17/13621/16414/11411/13712/10014/1205/9112/1219/8518/1198/8013/11514/7911/11310/7911/1099/749/10410/688/102
Weakness on one or both sides of the bodyGeneral disorders21/13623/16418/11414/1379/10010/1207/919/1219/8515/1196/8010/1157/7911/1136/7913/10910/7410/1045/689/102

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Standard Treatment + Placebo VareniclineBASC + Placebo VareniclineStandard Treatment + Active VareniclineBASC + Active VareniclineTotal
<=18 years00000
Between 18 and 65 years63587475270
>=65 years5107830
Age, Continuous
Age, Continuous(years)Standard Treatment + Placebo VareniclineBASC + Placebo VareniclineStandard Treatment + Active VareniclineBASC + Active VareniclineTotal
Mean50.3 ± 10.850.7 ± 13.548.7 ± 12.750.3 ± 13.250.0 ± 12.6
Sex: Female, Male
Sex: Female, Male(Participants)Standard Treatment + Placebo VareniclineBASC + Placebo VareniclineStandard Treatment + Active VareniclineBASC + Active VareniclineTotal
Female39384444165
Male29303739135
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Standard Treatment + Placebo VareniclineBASC + Placebo VareniclineStandard Treatment + Active VareniclineBASC + Active VareniclineTotal
American Indian or Alaska Native00112
Asian01304
Native Hawaiian or Other Pacific Islander00000
Black or African American40374337157
White25272836116
More than one race134816
Unknown or Not Reported20215
Region of Enrollment
Region of Enrollment(participants)Standard Treatment + Placebo VareniclineBASC + Placebo VareniclineStandard Treatment + Active VareniclineBASC + Active VareniclineTotal
United States68688183300
08

Study locations

2 sites
  • Northwestern University
    Chicago, Illinois 60611, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
09

References and documents

Publications

  • Anthenelli RM, Morris C, Ramey TS, Dubrava SJ, Tsilkos K, Russ C, Yunis C. Effects of varenicline on smoking cessation in adults with stably treated current or past major depression: a randomized trial. Ann Intern Med. 2013 Sep 17;159(6):390-400. doi: 10.7326/0003-4819-159-6-201309170-00005. Erratum In: Ann Intern Med. 2013 Oct 15;159(8):576. PubMed 24042367 ↗
  • Blalock JA, Robinson JD, Wetter DW, Schreindorfer LS, Cinciripini PM. Nicotine withdrawal in smokers with current depressive disorders undergoing intensive smoking cessation treatment. Psychol Addict Behav. 2008 Mar;22(1):122-8. doi: 10.1037/0893-164X.22.1.122. PubMed 18298238 ↗
  • Ebbert JO, Wyatt KD, Hays JT, Klee EW, Hurt RD. Varenicline for smoking cessation: efficacy, safety, and treatment recommendations. Patient Prefer Adherence. 2010 Oct 5;4:355-62. doi: 10.2147/ppa.s10620. PubMed 21049087 ↗
  • Gierisch JM, Bastian LA, Calhoun PS, McDuffie JR, Williams JW Jr. Smoking cessation interventions for patients with depression: a systematic review and meta-analysis. J Gen Intern Med. 2012 Mar;27(3):351-60. doi: 10.1007/s11606-011-1915-2. Epub 2011 Oct 26. PubMed 22038468 ↗
  • Hitsman B, Moss TG, Montoya ID, George TP. Treatment of tobacco dependence in mental health and addictive disorders. Can J Psychiatry. 2009 Jun;54(6):368-78. doi: 10.1177/070674370905400604. PubMed 19527557 ↗
  • Hitsman B, Papandonatos GD, McChargue DE, DeMott A, Herrera MJ, Spring B, Borrelli B, Niaura R. Past major depression and smoking cessation outcome: a systematic review and meta-analysis update. Addiction. 2013 Feb;108(2):294-306. doi: 10.1111/add.12009. PubMed 23072580 ↗
  • Philip NS, Carpenter LL, Tyrka AR, Whiteley LB, Price LH. Varenicline augmentation in depressed smokers: an 8-week, open-label study. J Clin Psychiatry. 2009 Jul;70(7):1026-31. doi: 10.4088/jcp.08m04441. Epub 2009 Mar 24. PubMed 19323966 ↗
  • MacPherson L, Tull MT, Matusiewicz AK, Rodman S, Strong DR, Kahler CW, Hopko DR, Zvolensky MJ, Brown RA, Lejuez CW. Randomized controlled trial of behavioral activation smoking cessation treatment for smokers with elevated depressive symptoms. J Consult Clin Psychol. 2010 Feb;78(1):55-61. doi: 10.1037/a0017939. PubMed 20099950 ↗

Study documents

  • Protocol and statistical analysis plan · Jun 25, 2019
  • Informed consent form · Aug 21, 2019

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02378714
Lead sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
Responsible party
Brian Hitsman (Associate Professor of Preventive Medicine, Northwestern University) — Principal investigator
First posted
Mar 4, 2015
Start date
Jul 24, 2015
Primary completion
Mar 13, 2020
Completion
Mar 13, 2020
Results posted
May 27, 2021
Last update
Jul 29, 2021

Study contacts

Brian Hitsman, Ph.D.
principal investigator · Northwestern University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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