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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34DA031038-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Southern Methodist University | OTHER |
| University of Houston | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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During the 1-year formative phase of a study to develop an integrated treatment for quitting smoking for anxiety-vulnerable HIV+ smokers. During this first phase of the study, start-up activities will include piloting the integrated treatment on a small group of individuals (N = up to 12), obtaining expert consultant and participant feedback, and development of the final treatment manual and procedures. The goal during this phase will be to establish feasibility of treatment delivery, participant acceptability, and potential for a treatment effect before conducting a pilot randomized trial of the treatment. During the two-year pilot RCT phase of the above study, we directly develop and test a novel psychosocial/behavioral and pharmacological smoking cessation intervention for HIV+ smokers with interfering psychological distress.
This study represents an important step in treating nicotine dependence in HIV-positive individuals. This study addresses an important public health issue by assessing an intervention that may lead to a more effective application for the treatment of at-risk HIV+ smokers. The 1-year formative phase of the study will develop an integrated treatment for quitting smoking for anxiety-vulnerable HIV+ smokers. The proposed treatment will include cognitive-behavioral talk therapy for quitting smoking, a nicotine patch, and cognitive-behavioral talk therapy for anxiety. The pilot of the proposed treatment will be conducted with a small group of individuals (N = up to 12). This phase will be used to establish feasibility of treatment delivery, and participant acceptability before conducting a pilot randomized trial of the treatment. Additionally, this phase will monitor smoking cessation history through Point Prevalence Abstinence (PPA), as well as anxiety symptoms through the Anxiety Sensitivity Index (ASI) at the baseline and follow-up assessments. This study represents an important step in treating nicotine dependence in HIV-positive individuals. This study addresses an important public health issue by assessing an intervention that may lead to a more effective application for the treatment of at-risk HIV+ smokers. The pilot RCT phase of the study (years 2 and 3), will test the developed cognitive-behavioral intervention in a pilot randomized-controlled trial format. The outcomes for this trial will be to determine the acceptability and feasibility of the intervention and the potential for an effect on increasing point prevalence abstinence and deceasing psychological distress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Intervention Arm | Experimental | Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress. |
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| Control Arm | Other | Enhanced Treatment as Usual (ETAU); enhanced standard smoking cessation treatment and nicotine replacement therapy (NRT). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated cognitive-behavioral therapy for smoking cessation and anxiety | Behavioral | Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Acceptability | Acceptability is defined as intervention participant study completion. Study completion was defined by participants attending at least 7/10 treatment sessions. Qualitative interviews were also conducted with participants at the end of the study. | 6 months |
| Long-term Point Prevalence Abstinence (PPA; Pilot RCT Phase) | Smoking outcomes are assessed at 6-month follow up by comparing the reported 7 day abstinence (assessed through self-report and independent verification) across the randomized conditions controlling for pre-randomization levels. | 6 months |
| Short-term Point Prevalence Abstinence (PPA; Pilot RCT Phase) | Smoking outcomes are assessed at end of treatment by comparing the reported 7 day abstinence (assessed through self-report and independent verification) across the randomized conditions controlling for pre-randomization levels. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Related Changes in Psychological Distress. | Treatment related changes in psychological distress was measured by combining the SIGH-A, MADRS, STAI-S, and CES-D into one scale score between baseline and the 6-month follow-up. In accordance with published recommendations, each psychological measure was z-scored to put all outcomes on the same scale. A z-score below 0 indicates a level of psychological distress below the mean (lower psychological distress), while a z-score above 0 indicates a level of psychological distress above the mean (higher psychological distress). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Conall O'Cleirigh, Ph.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39101506 | Derived | Mdege ND, Shah S, Dogar O, Pool ER, Weatherburn P, Siddiqi K, Zyambo C, Livingstone-Banks J. Interventions for tobacco use cessation in people living with HIV. Cochrane Database Syst Rev. 2024 Aug 5;8(8):CD011120. doi: 10.1002/14651858.CD011120.pub3. | |
| 30212438 | Derived | O'Cleirigh C, Zvolensky MJ, Smits JAJ, Labbe AK, Coleman JN, Wilner JG, Stanton AM, Gonzalez A, Garey L, Regenauer KS, Rosenfield D. Integrated Treatment for Smoking Cessation, Anxiety, and Depressed Mood in People Living With HIV: A Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2018 Oct 1;79(2):261-268. doi: 10.1097/QAI.0000000000001787. |
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72 participants were officially consented, 71 participants completed baseline (1 lost to follow-up), and 53 participants attended Session 1 after baseline (10 found ineligible at baseline, 8 lost to follow-up). Randomization occurred at the end of Session 1; therefore, only participants who attended Session 1 (N=53) were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Intervention Arm | Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress. Integrated cognitive-behavioral therapy for smoking cessation and anxiety: Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress. |
| FG001 | Control Arm | Enhanced Treatment as Usual (ETAU); enhanced standard smoking cessation treatment and nicotine replacement therapy (NRT). Control: Enhanced standard smoking cessation treatment and NRT. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Intervention Arm | Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress. Integrated cognitive-behavioral therapy for smoking cessation and anxiety: Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Acceptability | Acceptability is defined as intervention participant study completion. Study completion was defined by participants attending at least 7/10 treatment sessions. Qualitative interviews were also conducted with participants at the end of the study. | Posted | Count of Participants | Participants | 6 months |
|
1 year
Information was collected and reported for both study-related and non-study related adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral Intervention Arm | Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress. Integrated cognitive-behavioral therapy for smoking cessation and anxiety: Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for dizziness | Endocrine disorders | Non-systematic Assessment | Participant hospitalized for feeling dizzy. After being released from hospital, participant engaged with their primary care provider and an endocrinologist. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Non-systematic Assessment | Patient went to the emergency department for symptoms of pneumonia, but was not admitted to the hospital. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Conall O'Cleirigh, PI | Massachusetts General Hospital | (617) 643-0385 | cocleirigh@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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For formative stage of the study, no masking was used as that phase was an open pilot. Outcomes assessor masked during the pilot RCT.
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| Control | Behavioral | Enhanced standard smoking cessation treatment and NRT. |
|
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| 6 months |
| Completed <7 sessions (intervention) |
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| BG001 | Control Arm | Enhanced Treatment as Usual (ETAU); enhanced standard smoking cessation treatment and nicotine replacement therapy (NRT). Control: Enhanced standard smoking cessation treatment and NRT. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Long-term Point Prevalence Abstinence (PPA; Pilot RCT Phase) | Smoking outcomes are assessed at 6-month follow up by comparing the reported 7 day abstinence (assessed through self-report and independent verification) across the randomized conditions controlling for pre-randomization levels. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Primary | Short-term Point Prevalence Abstinence (PPA; Pilot RCT Phase) | Smoking outcomes are assessed at end of treatment by comparing the reported 7 day abstinence (assessed through self-report and independent verification) across the randomized conditions controlling for pre-randomization levels. | Posted | Count of Participants | Participants | 10 weeks |
|
|
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| Secondary | Treatment Related Changes in Psychological Distress. | Treatment related changes in psychological distress was measured by combining the SIGH-A, MADRS, STAI-S, and CES-D into one scale score between baseline and the 6-month follow-up. In accordance with published recommendations, each psychological measure was z-scored to put all outcomes on the same scale. A z-score below 0 indicates a level of psychological distress below the mean (lower psychological distress), while a z-score above 0 indicates a level of psychological distress above the mean (higher psychological distress). | Posted | Mean | Standard Deviation | z-score | 6 months |
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| 0 |
| 26 |
| 1 |
| 26 |
| 0 |
| 26 |
| EG001 | Control Arm | Enhanced Treatment as Usual (ETAU); enhanced standard smoking cessation treatment and nicotine replacement therapy (NRT). Control: Enhanced standard smoking cessation treatment and NRT. | 0 | 27 | 4 | 27 | 3 | 27 |
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| Hospitalization for leg blockage | Cardiac disorders | Non-systematic Assessment | Participant experienced a leg blockage for which they were admitted to hospital for treatment. |
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| Hospitalization for psychiatric reasons | Psychiatric disorders | Non-systematic Assessment | Participant experienced acute psychiatric symptoms and was hospitalized for treatment. |
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| Surgery | Surgical and medical procedures | Non-systematic Assessment |
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| Hospitalization for overdose | Injury, poisoning and procedural complications | Non-systematic Assessment | Accidental double dose of medication not related to the study. |
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| Intense Anxiety | Psychiatric disorders | Non-systematic Assessment | Patient went to the emergency department due to symptoms of intense anxiety. Was not hospitalized, but the psychiatrist in the ED increased their anti-anxiety medication dosage. |
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| Nicotine Patch Negative Effects | General disorders | Non-systematic Assessment | Within an hour of two of putting on nicotine patch for first time, patient experienced heart racing, vomiting, nausea, inability to leave bed, and thoughts/feelings of dread. Took off patch and symptoms subsided. |
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| D001519 | Behavior |