Table 2.
Assessment | Frequency | Purpose and Psychometrics |
---|---|---|
Diagnostic and Screening Measures | ||
Demographics Form | Screen | To gather basic demographic information. |
Composite International Diagnostic Interview (CIDI) (Modules A, J, & L) | Screen | To obtain substance use diagnoses. Tests of the reliability of the CIDI-SAM based on DSM-IV diagnoses for cocaine dependence compared to SCID interviews done by trained clinicians, had percent agreement of 82.6%, with kappa = 0.61. With specific criteria for the diagnosis, kappas ranged between 0.68 and 0.55. |
Mini International Neuropsychiatric Interview (MINI) | Screen | To identify Axis I psychiatric diagnoses (excluding substance use disorders). In comparison to the Structured Clinical Interview for DSM-IV Disorders (SCID-P), kappa values were good (only one diagnosis < .50), specificities and negative predictive values were .85 or higher across diagnoses, and in general, sensitivity was .70 or higher [113]. |
Locator Form | Screen, monthly | To obtain contact information for each participant. |
Prior and Concomitant Medications | Screen, weekly | To assess prescribed medications taken by the participant. |
Self-Administered Comorbidity Questionnaire (SCQ) | Screen | To assess the presence of medical problems, their severity, and whether or not the condition limits functioning. An intraclass correlation coefficient of 0.94 shows good test-retest reliability and is comparable to the Charlson Index intraclass correlation coefficient of 0.92. |
Physical Activity Readiness Questionnaire-Revised (PAR-Q) | Screen | To determine whether a person needs to consult with their physician prior to engaging in an exercise program. |
Medical History- Self-report Form | Screen | To obtain information that will facilitate the conduct of the physical exam, clinician-rated medical history, and maximal exercise test. |
Maximal Exercise Test Screening Questions | Screen | To aid the medical personnel in ensuring that it is safe for the participant to undergo the maximal exercise test |
Maximal Exercise Testing | Screen, week 13 | To examine cardiorespiratory responses in order to rule out ischemic response to exercise, to identify participants for whom exercise might be hazardous, and to provide data for the exercise prescription. |
Physical Exam/Medical History | Screen | To provide clearance for exercise. |
Laboratory Tests | Screen | To provide clearance for exercise. |
Substance Use and Treatment Assessments | ||
Timeline Followback (TLFB)* *Primary outcome measure |
Screen, 3X/wk for 1st 3 months, 1X/wk for next 6 months | To quantify days of substance use for calculation of primary outcome (percent days abstinent). The TLFB has been shown to have high test-retest reliability (ICC values ranging from 0.70 to .94, with all p < 0.001), good convergent and discriminate validity, and acceptable agreement between the TLFB and urine drug screens (Yule's Y of 87 or greater for amphetamines and cocaine)[114]. |
Urine Drug Screen (UDS) | Baseline, 3X/wk for 1st 3 months, 1X/wk for next 6 months | To test for substance use and to inform TLFB. |
Stimulant Craving Questionnaire-Brief (STCQ-Brief) | Baseline, weekly | To assess current craving for stimulants. The CCQ-Brief, from which the STCQ-Brief is adapted, has high internal consistency, with Cronbach's alpha ranging from 0.87 [115] to 0.90 [61]. The instrument also has good construct validity and has shown to correlate well with other craving measures [115]. |
Stimulant Selective Severity Assessment (SSSA) | Baseline, weekly | To assess signs and symptoms of stimulant abstinence. The Cocaine Selective Severity Assessment, from which the SSSA is adapted, has been shown to have good inter-rater reliability (correlation coefficient = 0.92, p < 0.001) and internal consistency (Cronbach's alpha = 0.80). |
Addiction Severity Index-Lite (ASI-Lite) | Baseline, weeks 13, 25, 37 | To assess common problems associated with drug use. The CTN version is similar to the ASI-Lite-Veterans Administration (ASI-L-VA) and should have similar psychometric characteristics. Specifically, intraclass correlations between the ASI fifth edition (ASI-5) and ASSI-L-VA are 0.79 for alcohol, 0.79 for drug, 0.85 for legal, 0.46 for family/social, and 0.53 for psychiatric [116]. |
Fagerstrom Test for Nicotine Dependence (FTND) | Baseline | To assess dependence on nicotine. The FTND has shown acceptable internal consistency (Cronbach's alpha of 0.61) and correlates significantly with other measures of smoking consumption. |
Treatment as Usual (TAU) Tracking Form | Baseline, weekly | To assess the participant's treatment for substance abuse within the past week. |
Measures of Mood, Sleep and Anhedonia | ||
Quick Inventory of Depressive Symptomatology- Clinician rated version (QIDS-C16) | Baseline, weekly | To assess severity of depression-specific symptoms. The internal consistency coefficient is high (Cronbach's alpha of 0.90)[70]. It also has good concurrent validity, with correlations between the QIDS and the 17-item Hamilton Rating Scale for Depression ranging between .86 and .93. It also has been shown to have good inter-rater reliability with a kappa of .85. |
Concise Health Risk Tracking- Self-report (CHRT-SR) | Baseline, weekly | To assess suicidality and related thoughts and behaviors. The CHRT-SR has good internal consistency (Cronbach's alpha of 0.78). |
Concise Associated Symptoms Tracking- Self-report (CAST-SR) | Baseline, weekly | To assess symptoms related to suicidal thoughts and behaviors. The internal consistency coefficient for the CAST-SR is good (Cronbach's alpha of 0.77). |
Snaith-Hamilton Pleasure Scale (SHAPS) | Baseline, monthly | To measure anhedonia, the inability to experience pleasure. The SHAPS has adequate construct validity, satisfactory test-retest reliability [117], and high internal consistency (Cronbach's alpha of 0.94)[117]. |
Psychosocial Assessments | ||
Short-Form Health Survey (SF-36) | Baseline, monthly | To assess quality of life and general health. Internal consistency reliability coefficients for the SF-36 are high (all greater than 0.80). Test-retest coefficients range from 0.43 to 0.90 for a 6-month interval and from 0.60 to 0.81 for a 2-week interval. The SF-36 has been shown to correlate moderately well with other health measures. |
Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) | Baseline, monthly | To evaluate general life enjoyment and satisfaction. Test-retest reliability for the Q-LES-Q-SF has been shown to be .86 [118] and internal consistency (Cronbach's alpha) has been shown to range from .86 to .90 [118,119]. |
Pain Frequency, Intensity and Burden Scale (P-FIBS) | Baseline, monthly | To evaluate the frequency, intensity, and burden of pain over the past week, as well as usage of pain medication to manage pain. |
Cognitive Function Assessments | ||
Wechsler Test of Adult Reading (WTAR) | Baseline | To assess pre-morbid intelligence. The WTAR has been established to be a reliable and valid assessment of pre-morbid intelligence. It has been normed with the Wechsler Adult Intelligence Scale (WAIS-III) and the Wechsler Memory Scale (WMS-III). |
MGH Cognitive and Physical Functioning Questionnaire (CPFQ) | Baseline, monthly | To assess physical well-being and cognitive and executive dysfunction. The CPFQ has been shown to have high internal consistency with a Cronbach's alpha of 0.90 and test-retest reliability (0.83, p < 0.001)[120]. |
Stroop Color and Word Test (Stroop) | Baseline, weeks 13, 37 | To measure attention response inhibition. |
Physiological Measures | ||
Physiological Measures | Baseline, monthly (height once at baseline, weight weekly) | To measure height, weight, body mass index (BMI), and waist circumference |
Exercise Readiness Form | Baseline, each supervised exercise session (3X/wk for 1st 3 months, 1X/wk for next 6 months) | To measure resting heart rate and blood pressure for those in the exercise condition in order to evaluate safety for exercise. |
Retention | ||
Treatment Participation Questionnaire (TPQ) | Baseline, weekly | To assess participant's likelihood of remaining in treatment. |