Alcohol-Related Disorders, Anxiety Disorders
Conditions
Keywords
Venlafaxine, Alcoholism, Anxiety Disorders, Alcohol-Use Disorders, Alcohol Abuse, Alcohol Dependence, Cognitive Behavioral Treatment
Brief summary
The proposed project is written as a typical clinical practice test and is a fully-controlled trial of a combined anxiety-focused CBT and pharmacotherapy (venlafaxine; CBT-VEN) delivered for patients with comorbid alcohol-use and anxiety disorders. The CBT and pharmacotherapy will be contrasted with relaxation training and placebo medication. One hundred and eighty participants will be recruited and, subsequent to a platform of outpatient treatment for alcoholism, will be randomly assigned to a 12-week treatment condition. All treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine or placebo. The treatments will conclude with a 2-week medication/placebo taper. Follow-up assessments will be conducted at post-treatment and at 3, 6, 9, and 12-months. The long-term objectives of this research are to develop a real-world combination of psychosocial and pharmacological treatments for patients with comorbid alcohol-use and anxiety disorders that compromise prognosis, and to evaluate the effectiveness of combined psychosocial and pharmacological treatments that target anxiety among patients with this comorbidity.
Detailed description
Difficulties in anxiety management are frequent causes of relapse to alcohol use. Empirical data support the role of anxiety in alcohol relapse, and both psychosocial and pharmacological treatments for alcohol problems increasingly address the role of negative affect in alcohol-use disorders. Due to the lack of large, well-controlled treatment outcome trials, the optimal treatment (or combination of treatments) remains unknown. Real world practice in the treatment of alcohol-use disorders frequently begins with brief detoxification and stabilization, and is often followed by some combination of CBT and pharmacotherapy for patients complaining of mood difficulties while attempting early abstinence from alcohol. The purpose of the present study is to evaluate the relative benefits of psychosocial and psychopharmacological therapy for the treatment of co-morbid anxiety and alcohol dependence among patients attempting early abstinence from alcohol. We will address the following four questions: 1. During the course of intervention, is treatment of anxiety disorders with combined treatments of established utility (among non-alcohol-use-disordered patients) superior in managing both return to drinking and anxiety symptoms than either monotherapy, or a fully inactive control treatment? 2. During the follow-up period, will patients who received the combined active treatments fare better in maintaining abstinence relative to the single active treatments, and those in the control condition? 3. What psychosocial variables (such as increases or lapses to elevated anxiety) mediate return to pre-treatment levels of alcohol use? 4. Will baseline indices of alcohol dependence and anxiety disorder severity moderate the relationship between treatment and outcome during both the acute and follow-up phases of the study?
Interventions
DRUGVenlafaxine
Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
BEHAVIORALCBT
CBT is Cognitive Behavioral Therapy. Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
OTHERProgressive muscle relaxation therapy (PMR)
For patients with comorbid alcohol-use and anxiety disorders, CBT and pharmacotherapy will be contrasted with relaxation training and placebo medication; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine or placebo.
OTHERPlacebo medication
For patients with comorbid alcohol-use and anxiety disorders, CBT and pharmacotherapy will be contrasted with relaxation training and placebo medication; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine or placebo.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants must be English-speaking males or females * Participants must be between 18 and 65 years old * Meet criteria for DSM-IV diagnosis of alcohol abuse or dependence * Meet criteria for Panic disorder, Social Phobia or Generalized Anxiety Disorder * Physically able to attend sessions at the Counseling Center * Able to read and write * Able to complete the structured interview and self-report assessment packet * Able to attend all treatment sessions and follow-up assessments * Able to sign a witnessed informed consent form * Participants express a desire to completely stop drinking alcohol or reduce alcohol consumption with the possible long-term goal of abstinence
Exclusion criteria
* Meet DSM-IV diagnostic criteria for bipolar disorder, schizophrenia, bulimia/anorexia, or dementia * Currently taking anti-craving agents (e.g. Naltrexone, methadone) * Currently taking medication that has clinically significant interactions with venlafaxine * Previous use of venlafaxine * Currently taking other antidepressant medications * Currently taking medication known to decrease anxiety or alcohol consumption (e.g. antabuse) * Currently prescribed medications with known abuse potential (e.g., subjects on opioid agonist therapy) * Currently prescribed medications as a sleep aid (e.g. Ambien) * Currently taking herbal supplements that have been shown to interact with venlafaxine or affect anxiety symptoms * Currently pregnant, breastfeeding, plans of becoming pregnant during the course of the study, or not using medically acceptable form of birth control (oral contraceptives, barrier \[diaphragm or condom\] with spermicide, intrauterine progesterone contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection). * Planning to relocate out-of-state within four months of protocol initiation * History of psychotic symptoms within the past 30 days * Experiencing severe symptoms of depression or have engaged in suicidal behaviors within the past 30 days * Medical contraindications to the use of venlafaxine \[severe renal disease, cirrhosis, uncontrolled blood pressure, recent cardiovascular problems (e.g., heart attack), and seizure disorders; currently taking a monoamine oxidase inhibitor, MAOI\] * Self-reported anxiety less than 15 on the Hamilton Rating Scale for Anxiety * Participant is a member of the same household of another subject already participating in the study * Participant is legally mandated (e.g., to avoid incarceration, monetary or other penalties, etc.) to participate in an alcohol treatment program * Participant has a current or recent (past 30 days) DSM-IV diagnosis of other substance abuse or dependence, with the exception of nicotine, marijuana, and caffeine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression Scale-I (CGI-I) | Session 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment) | Global improvement of alcohol dependence: Rate the total improvement in the participant's alcohol dependence symptoms whether or not, in your judgment, it is due entirely to treatment. Compared to his/her admission to the project, how much has s/he changed? (1-Not assessed, first rating, 2-Very much improved, 3-Much improved, 4-Minimally improved, 5-Unchanged, 6-Minimally worse, 7-Much worse, 8-Very much worse) |
| Clinical Global Impression Scale-S (CGI-S) | 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment) | Global severity of alcohol dependence: Considering your total clinical experience with the alcohol dependent population how severe are his/her alcohol dependence symptoms at this time? (1-Normal, no symptoms, 2-Borderline symptoms, 3-Mild symptoms, 4-Moderate symptoms, 5-Marked symptoms, 6-Severe symptoms, 7-Among the most extreme symptoms) |
| Craving Desire Scale (CDS) | 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment) | The Craving Desire Scale (CDS) is a 3-item scale (1. I do want to drink now, 2. I crave a drink right now, 3. I have a desire for a drink right now) used to identify the degree of current alcohol craving, with responses provided on a Likert scale of 1-7: with 1 meaning strongly disagree, and 7 meaning strongly agree to each of the 3 items. Total scores can range from 3 to 21 with higher scores indicating greater craving for alcohol. |
| Number of Participants Abstinent | Session 8 (8 weeks of treatment) | Abstaining from the consumption of intoxicating beverages. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Completion | 12 months | The number and percent of participants that completed the treatment in each arm of the study. |
| HAM-D Scale | Session 1 (baseline), Session 8 (8 weeks of treatment) | HAM-D (Hamilton Rating Scale for Depression) is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. The scoring is based on 17 items. Eight of the items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine items are scored on a 3 point scale from 0-2 where 0=none or absent and 2= severe. The total scores for the HAM-D can range from 0 to 50. The total scores are interpreted as: 0-7=normal, 8-13=mild, 14-18= moderate, 19-22= severe, and 23+=very severe depression. The higher the score the more severe the participant's depression. |
| Medication Compliance Rates | 12 months | The medication compliance rate is the percentage of participants in each study arm who took their medication based on pill counts. |
| DASS Stress Subscale Score | Session 1 (baseline), Session 11 (11 weeks of treatment) | DASS (Depression Anxiety Stress Scales) assesses depression, anxiety and stress responses. Each of the three DASS scales contains 14 items, divided into subscales of 2-5 items with similar content. The stress subscale was used which assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient. Subjects are asked to use 4-point severity/frequency scales to rate the extent to which they have experienced each state over the past week. Stress scores can range form 0-56 with 0-14=normal, 15-18=mild, 19-25=moderate, 26-33=severe. and 34+=extremely severe stress. |
| HAM-A Scale | Session 1 (baseline), Session 8 (8 weeks of treatment) | The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety. The HAM-A probes 14 parameters each item is scored on a 5-point scale, ranging from 0=not present to 4=severe. total scores can range from 0 to 56.where \<17 indicates mild anxiety, 18-24 moderate anxiety and 25-30 severe anxiety. Higher scores reflect more anxiety. |
Countries
United States
Participant flow
Recruitment details
Following telephone screening (n=950), 162 eligible subjects completed an in-clinic baseline assessment #1 to determine eligibility for inclusion in the study.
Pre-assignment details
Once subjects achieved the four day period of abstinence they completed a second baseline assessment in which eligibility was re-assessed. 81 Eligible subjects were then randomized into the four study arms.
Participants by arm
| Arm | Count |
|---|---|
| Venlafaxine & CBT Venlafaxine (Effexor XR) and CBT (Cognitive Behavioral therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper. | 24 |
| Placebo & CBT Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper. | 21 |
| Venlafaxine & PMR Venlafaxine and PMR (progressive muscle relaxation therapy). | 14 |
| Placebo & PMR Placebo medication and PMR (progressive muscle relaxation therapy) | 22 |
| Total | 81 |
Baseline characteristics
| Characteristic | Venlafaxine & CBT | Placebo & CBT | Venlafaxine & PMR | Placebo & PMR | Total |
|---|---|---|---|---|---|
| ADS Scores | 15.0 units on a scale STANDARD_DEVIATION 7.6 | 15.8 units on a scale STANDARD_DEVIATION 7.7 | 16.6 units on a scale STANDARD_DEVIATION 6.6 | 16.1 units on a scale STANDARD_DEVIATION 5.9 | 15.8 units on a scale STANDARD_DEVIATION 7.6 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 21 Participants | 14 Participants | 22 Participants | 81 Participants |
| Drinking status percent days drinking | 72.0 percent of days STANDARD_DEVIATION 24.5 | 76.0 percent of days STANDARD_DEVIATION 25.6 | 88.0 percent of days STANDARD_DEVIATION 12.7 | 76.5 percent of days STANDARD_DEVIATION 25.8 | 77 percent of days STANDARD_DEVIATION 23.8 |
| Drinking status percent days heavy drinking | 63.1 percent of days STANDARD_DEVIATION 28 | 59.1 percent of days STANDARD_DEVIATION 33.7 | 76.9 percent of days STANDARD_DEVIATION 19.1 | 67.2 percent of days STANDARD_DEVIATION 28.6 | 65.6 percent of days STANDARD_DEVIATION 28.2 |
| Drinks per day | 8.4 number of drinks STANDARD_DEVIATION 6.5 | 7.0 number of drinks STANDARD_DEVIATION 4.6 | 9.6 number of drinks STANDARD_DEVIATION 4.3 | 9.7 number of drinks STANDARD_DEVIATION 7.5 | 8.6 number of drinks STANDARD_DEVIATION 6.1 |
| Race/Ethnicity, Customized African American | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 21 Participants | 18 Participants | 12 Participants | 19 Participants | 70 Participants |
| Region of Enrollment United States | 24 Participants | 21 Participants | 14 Participants | 22 Participants | 81 Participants |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 3 Participants | 5 Participants | 18 Participants |
| Sex: Female, Male Male | 18 Participants | 17 Participants | 11 Participants | 17 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 21 | 0 / 14 | 0 / 22 |
| other Total, other adverse events | 0 / 24 | 0 / 21 | 0 / 14 | 0 / 22 |
| serious Total, serious adverse events | 3 / 24 | 1 / 21 | 2 / 14 | 1 / 22 |
Outcome results
Primary
Clinical Global Impression Scale-I (CGI-I)
Global improvement of alcohol dependence: Rate the total improvement in the participant's alcohol dependence symptoms whether or not, in your judgment, it is due entirely to treatment. Compared to his/her admission to the project, how much has s/he changed? (1-Not assessed, first rating, 2-Very much improved, 3-Much improved, 4-Minimally improved, 5-Unchanged, 6-Minimally worse, 7-Much worse, 8-Very much worse)
Time frame: Session 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Venlafaxine & CBT | Clinical Global Impression Scale-I (CGI-I) | Session 1 CGI-I | 3.65 units on a scale | Standard Deviation 1.34 |
| Venlafaxine & CBT | Clinical Global Impression Scale-I (CGI-I) | Session 11 CGI-I | 3.13 units on a scale | Standard Deviation 1.3 |
| Venlafaxine & CBT | Clinical Global Impression Scale-I (CGI-I) | Session 8 CGI-I | 3.61 units on a scale | Standard Deviation 1.38 |
| Placebo & CBT | Clinical Global Impression Scale-I (CGI-I) | Session 1 CGI-I | 3.81 units on a scale | Standard Deviation 1.21 |
| Placebo & CBT | Clinical Global Impression Scale-I (CGI-I) | Session 11 CGI-I | 2.61 units on a scale | Standard Deviation 0.78 |
| Placebo & CBT | Clinical Global Impression Scale-I (CGI-I) | Session 8 CGI-I | 3.13 units on a scale | Standard Deviation 0.89 |
| Venlafaxine & PMR | Clinical Global Impression Scale-I (CGI-I) | Session 8 CGI-I | 3.50 units on a scale | Standard Deviation 1.09 |
| Venlafaxine & PMR | Clinical Global Impression Scale-I (CGI-I) | Session 1 CGI-I | 3.86 units on a scale | Standard Deviation 1.1 |
| Venlafaxine & PMR | Clinical Global Impression Scale-I (CGI-I) | Session 11 CGI-I | 3.00 units on a scale | Standard Deviation 1.15 |
| Placebo & PMR | Clinical Global Impression Scale-I (CGI-I) | Session 1 CGI-I | 4.05 units on a scale | Standard Deviation 0.65 |
| Placebo & PMR | Clinical Global Impression Scale-I (CGI-I) | Session 11 CGI-I | 2.92 units on a scale | Standard Deviation 0.95 |
| Placebo & PMR | Clinical Global Impression Scale-I (CGI-I) | Session 8 CGI-I | 3.53 units on a scale | Standard Deviation 1.19 |
Primary
Clinical Global Impression Scale-S (CGI-S)
Global severity of alcohol dependence: Considering your total clinical experience with the alcohol dependent population how severe are his/her alcohol dependence symptoms at this time? (1-Normal, no symptoms, 2-Borderline symptoms, 3-Mild symptoms, 4-Moderate symptoms, 5-Marked symptoms, 6-Severe symptoms, 7-Among the most extreme symptoms)
Time frame: 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Venlafaxine & CBT | Clinical Global Impression Scale-S (CGI-S) | Session 1 CGI-S | 4.00 units on a scale | Standard Deviation 1.24 |
| Venlafaxine & CBT | Clinical Global Impression Scale-S (CGI-S) | Session 11 CGI-S | 3.00 units on a scale | Standard Deviation 1.88 |
| Venlafaxine & CBT | Clinical Global Impression Scale-S (CGI-S) | Session 8 CGI-S | 3.28 units on a scale | Standard Deviation 1.49 |
| Placebo & CBT | Clinical Global Impression Scale-S (CGI-S) | Session 1 CGI-S | 3.76 units on a scale | Standard Deviation 0.89 |
| Placebo & CBT | Clinical Global Impression Scale-S (CGI-S) | Session 11 CGI-S | 2.53 units on a scale | Standard Deviation 1.18 |
| Placebo & CBT | Clinical Global Impression Scale-S (CGI-S) | Session 8 CGI-S | 2.88 units on a scale | Standard Deviation 1.26 |
| Venlafaxine & PMR | Clinical Global Impression Scale-S (CGI-S) | Session 8 CGI-S | 3.25 units on a scale | Standard Deviation 1.42 |
| Venlafaxine & PMR | Clinical Global Impression Scale-S (CGI-S) | Session 1 CGI-S | 3.93 units on a scale | Standard Deviation 0.92 |
| Venlafaxine & PMR | Clinical Global Impression Scale-S (CGI-S) | Session 11 CGI-S | 2.60 units on a scale | Standard Deviation 1.51 |
| Placebo & PMR | Clinical Global Impression Scale-S (CGI-S) | Session 1 CGI-S | 4.18 units on a scale | Standard Deviation 1.18 |
| Placebo & PMR | Clinical Global Impression Scale-S (CGI-S) | Session 11 CGI-S | 2.85 units on a scale | Standard Deviation 1.34 |
| Placebo & PMR | Clinical Global Impression Scale-S (CGI-S) | Session 8 CGI-S | 3.40 units on a scale | Standard Deviation 1.18 |
Primary
Craving Desire Scale (CDS)
The Craving Desire Scale (CDS) is a 3-item scale (1. I do want to drink now, 2. I crave a drink right now, 3. I have a desire for a drink right now) used to identify the degree of current alcohol craving, with responses provided on a Likert scale of 1-7: with 1 meaning strongly disagree, and 7 meaning strongly agree to each of the 3 items. Total scores can range from 3 to 21 with higher scores indicating greater craving for alcohol.
Time frame: 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Venlafaxine & CBT | Craving Desire Scale (CDS) | Session 1 CDS | 8.63 units on a scale | Standard Deviation 6.03 |
| Venlafaxine & CBT | Craving Desire Scale (CDS) | Session 11 CDS | 4.38 units on a scale | Standard Deviation 1.94 |
| Venlafaxine & CBT | Craving Desire Scale (CDS) | Session 8 CDS | 6.44 units on a scale | Standard Deviation 5.28 |
| Placebo & CBT | Craving Desire Scale (CDS) | Session 1 CDS | 8.14 units on a scale | Standard Deviation 5.02 |
| Placebo & CBT | Craving Desire Scale (CDS) | Session 11 CDS | 6.11 units on a scale | Standard Deviation 4.76 |
| Placebo & CBT | Craving Desire Scale (CDS) | Session 8 CDS | 7.41 units on a scale | Standard Deviation 5.06 |
| Venlafaxine & PMR | Craving Desire Scale (CDS) | Session 8 CDS | 4.45 units on a scale | Standard Deviation 1.75 |
| Venlafaxine & PMR | Craving Desire Scale (CDS) | Session 1 CDS | 8.21 units on a scale | Standard Deviation 5.94 |
| Venlafaxine & PMR | Craving Desire Scale (CDS) | Session 11 CDS | 5.10 units on a scale | Standard Deviation 2.08 |
| Placebo & PMR | Craving Desire Scale (CDS) | Session 1 CDS | 7.55 units on a scale | Standard Deviation 5.06 |
| Placebo & PMR | Craving Desire Scale (CDS) | Session 11 CDS | 4.25 units on a scale | Standard Deviation 2.7 |
| Placebo & PMR | Craving Desire Scale (CDS) | Session 8 CDS | 5.56 units on a scale | Standard Deviation 3.41 |
Primary
Number of Participants Abstinent
Abstaining from the consumption of intoxicating beverages.
Time frame: Session 8 (8 weeks of treatment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Venlafaxine & CBT | Number of Participants Abstinent | 2 Participants |
| Placebo & CBT | Number of Participants Abstinent | 4 Participants |
| Venlafaxine & PMR | Number of Participants Abstinent | 3 Participants |
| Placebo & PMR | Number of Participants Abstinent | 1 Participants |
Secondary
DASS Stress Subscale Score
DASS (Depression Anxiety Stress Scales) assesses depression, anxiety and stress responses. Each of the three DASS scales contains 14 items, divided into subscales of 2-5 items with similar content. The stress subscale was used which assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient. Subjects are asked to use 4-point severity/frequency scales to rate the extent to which they have experienced each state over the past week. Stress scores can range form 0-56 with 0-14=normal, 15-18=mild, 19-25=moderate, 26-33=severe. and 34+=extremely severe stress.
Time frame: Session 1 (baseline), Session 11 (11 weeks of treatment)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Venlafaxine & CBT | DASS Stress Subscale Score | Session 1 DASS stress subscale | 16.7 units on a scale | Standard Deviation 7.6 |
| Venlafaxine & CBT | DASS Stress Subscale Score | Session 11 DASS stress subscale | 8.1 units on a scale | Standard Deviation 4.6 |
| Placebo & CBT | DASS Stress Subscale Score | Session 11 DASS stress subscale | 9.6 units on a scale | Standard Deviation 7.9 |
| Placebo & CBT | DASS Stress Subscale Score | Session 1 DASS stress subscale | 19.2 units on a scale | Standard Deviation 9.1 |
| Venlafaxine & PMR | DASS Stress Subscale Score | Session 1 DASS stress subscale | 21.5 units on a scale | Standard Deviation 11.3 |
| Venlafaxine & PMR | DASS Stress Subscale Score | Session 11 DASS stress subscale | 4.1 units on a scale | Standard Deviation 7.9 |
| Placebo & PMR | DASS Stress Subscale Score | Session 1 DASS stress subscale | 16.6 units on a scale | Standard Deviation 8.2 |
| Placebo & PMR | DASS Stress Subscale Score | Session 11 DASS stress subscale | 11.2 units on a scale | Standard Deviation 11.1 |
Secondary
HAM-A Scale
The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety. The HAM-A probes 14 parameters each item is scored on a 5-point scale, ranging from 0=not present to 4=severe. total scores can range from 0 to 56.where \<17 indicates mild anxiety, 18-24 moderate anxiety and 25-30 severe anxiety. Higher scores reflect more anxiety.
Time frame: Session 1 (baseline), Session 8 (8 weeks of treatment)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Venlafaxine & CBT | HAM-A Scale | Session 1 HAM-A | 13.5 units on a scale | Standard Deviation 5.9 |
| Venlafaxine & CBT | HAM-A Scale | Session 8 HAM-A | 9.8 units on a scale | Standard Deviation 6.9 |
| Placebo & CBT | HAM-A Scale | Session 8 HAM-A | 9.1 units on a scale | Standard Deviation 5.5 |
| Placebo & CBT | HAM-A Scale | Session 1 HAM-A | 14.2 units on a scale | Standard Deviation 7.3 |
| Venlafaxine & PMR | HAM-A Scale | Session 1 HAM-A | 16.5 units on a scale | Standard Deviation 6.8 |
| Venlafaxine & PMR | HAM-A Scale | Session 8 HAM-A | 7.9 units on a scale | Standard Deviation 5.5 |
| Placebo & PMR | HAM-A Scale | Session 1 HAM-A | 12.9 units on a scale | Standard Deviation 4.1 |
| Placebo & PMR | HAM-A Scale | Session 8 HAM-A | 9.1 units on a scale | Standard Deviation 4.2 |
Secondary
HAM-D Scale
HAM-D (Hamilton Rating Scale for Depression) is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. The scoring is based on 17 items. Eight of the items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine items are scored on a 3 point scale from 0-2 where 0=none or absent and 2= severe. The total scores for the HAM-D can range from 0 to 50. The total scores are interpreted as: 0-7=normal, 8-13=mild, 14-18= moderate, 19-22= severe, and 23+=very severe depression. The higher the score the more severe the participant's depression.
Time frame: Session 1 (baseline), Session 8 (8 weeks of treatment)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Venlafaxine & CBT | HAM-D Scale | Session 1 HAM-D | 12.0 units on a scale | Standard Deviation 5.7 |
| Venlafaxine & CBT | HAM-D Scale | Session 8 HAM-D | 8.8 units on a scale | Standard Deviation 6.6 |
| Placebo & CBT | HAM-D Scale | Session 8 HAM-D | 8.5 units on a scale | Standard Deviation 4.6 |
| Placebo & CBT | HAM-D Scale | Session 1 HAM-D | 11.7 units on a scale | Standard Deviation 6 |
| Venlafaxine & PMR | HAM-D Scale | Session 1 HAM-D | 13.0 units on a scale | Standard Deviation 7.2 |
| Venlafaxine & PMR | HAM-D Scale | Session 8 HAM-D | 5.9 units on a scale | Standard Deviation 5.6 |
| Placebo & PMR | HAM-D Scale | Session 1 HAM-D | 13.6 units on a scale | Standard Deviation 5 |
| Placebo & PMR | HAM-D Scale | Session 8 HAM-D | 10 units on a scale | Standard Deviation 6.2 |
Secondary
Medication Compliance Rates
The medication compliance rate is the percentage of participants in each study arm who took their medication based on pill counts.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Venlafaxine & CBT | Medication Compliance Rates | 96.89 percentage of participants |
| Placebo & CBT | Medication Compliance Rates | 97.06 percentage of participants |
| Venlafaxine & PMR | Medication Compliance Rates | 88.70 percentage of participants |
| Placebo & PMR | Medication Compliance Rates | 95.39 percentage of participants |
Secondary
Treatment Completion
The number and percent of participants that completed the treatment in each arm of the study.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Venlafaxine & CBT | Treatment Completion | 18 Participants |
| Placebo & CBT | Treatment Completion | 17 Participants |
| Venlafaxine & PMR | Treatment Completion | 11 Participants |
| Placebo & PMR | Treatment Completion | 15 Participants |