Prospectively assessed summer mood status in major depression, recurrent with seasonal pattern: Evidence for SAD's construct validity.

OBJECTIVE: Seasonal patterns are often undetectable in population-based depression studies, calling into question the existence of winter seasonal affective disorder (SAD). If SAD has construct validity, individuals with SAD should show spontaneous depression remission in the summer. Data are sparse on prospectively assessed summer mood status in confirmed SAD patients. METHOD: We conducted prospective summer followup of community adults who, the winter before, were diagnosed with Major Depression, Recurrent with Seasonal Pattern on the Structured Clinical Interview for DSM-IV Axis I Disorders, developed a current SAD episode on the Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD), and enrolled in a clinical trial comparing group cognitive-behavioral therapy for SAD and light therapy. In July/August after treatment, 143/153 (93.5 %) participants provided data on the SIGH-SAD, the Beck Depression Inventory-Second Edition, and the Longitudinal Interval Followup Evaluation (LIFE). RESULTS: Summer mean depression scores were in the normal range, with the substantial majority in remission across different measures. On the LIFE, 113/143 (79.0 %) experienced complete summer remission, 19/143 (13.3 %) experienced partial summer remission, and 11/143 (7.7 %) had major depression in the summer. Depression scores were significantly lower at summer than post-treatment in both treatments, indicating incomplete treatment response. LIMITATIONS: This was a single-site study with a relatively homogeneous sample. CONCLUSIONS: Supporting construct validity for SAD, the substantial majority experienced complete summer remission, with a minority in partial remission and a very small minority in episode. Both treatments left residual symptoms at treatment endpoint compared to summer.

Change in Seasonal Beliefs Mediates the Durability Advantage of Cognitive-Behavioral Therapy Over Light Therapy for Winter Depression.

In treating an acute episode of winter depression, cognitive-behavioral therapy for seasonal affective disorder (CBT-SAD) and light therapy are comparably efficacious, with improvement in depression symptoms during CBT-SAD mediated by reduced seasonal beliefs (i.e., maladaptive thoughts about the seasons, light availability, and weather). Here, we tested whether the enduring benefit of CBT-SAD over light therapy following treatment is associated with offsetting seasonal beliefs during CBT-SAD. Currently depressed adults with Major Depression, Recurrent with Seasonal Pattern (N = 177) were randomized to 6 weeks of light therapy or group CBT-SAD and followedup one and two winters after treatment. Outcomes measured during treatment and at each follow-up included depression symptoms on the Structured Clinical Interview for the Hamilton Rating Scale for Depression-SAD Version and Beck Depression Inventory-Second Edition. Candidate mediators measured at pre-, mid-, and posttreatment were SAD-specific negative cognitions (Seasonal Beliefs Questionnaire; SBQ); general depressogenic cognitions (Dysfunctional Attitudes Scale; DAS); brooding rumination (Ruminative Response Scale-Brooding subscale; RRS-B); and chronotype (Morningness-Eveningness Questionnaire; MEQ). Latent growth curve mediation models found a significant positive path from treatment group to the slope of SBQ during treatment, with CBT-SAD showing larger improvements in seasonal beliefs with overall change in seasonal beliefs in the medium-effect range, and significant positive paths from SBQ slope to depression scores at the first and second winter follow-ups, indicating greater change towards more flexible seasonal beliefs during active treatment was associated with less severe depression symptoms following treatment. Estimated indirect effects (treatment group → SBQ change * SBQ change → outcome) were also significant at each follow-up for each outcome with ßindirect ranging from .091 to .162. Models also found significant positive paths from treatment group to the slope of MEQ and RRS-B during treatment, with light therapy showing a greater increase in "morningness" and CBT-SAD showing a greater decrease in brooding during active treatment; however, neither construct emerged as a mediator of follow-up depression scores. Change in seasonal beliefs during treatment mediates both the acute antidepressant and long-term effects of CBT-SAD and explains lower depression severity following CBT-SAD relative to light therapy.

Body mass index and atypical balance as predictors of winter depression remission in cognitive-behavioral therapy and light therapy.

BACKGROUND: Efficacious treatments for winter seasonal affective disorder (SAD) include light therapy (LT) and cognitive-behavioral therapy (CBT-SAD); however, baseline characteristics may differentially predict treatment outcomes. This study investigated body mass index (BMI) and atypical balance (the proportion of atypical depression symptoms), as predictors of depression remission. METHODS: The parent study randomized 177 adults diagnosed with Major Depression, Recurrent with Seasonal Pattern to 6-weeks of CBT-SAD (n = 88) or LT (n = 89) and followed participants one and two winters later. At baseline, BMI was measured and atypical balance was derived using the Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD) as 8-item atypical subscale score/total SIGH-SAD score × 100. Depression remission was defined using standard SIGH-SAD cutpoints. Hierarchical logistic regressions tested the main effects of treatment modality, BMI, and atypical balance and their interactive effects on depression remission at post-treatment and follow-ups. RESULTS: The BMI × treatment and atypical balance × treatment interactions significantly predicted depression remission at second winter follow-up. The probability of remission was higher in CBT-SAD than LT at BMI ≤ 26.1 and atypical balance ≤ 40.3%. This predictive relationship survived when adjusting atypical balance for BMI, but not vice-versa. LIMITATIONS: Participants were predominantly White and older. BMI does not account for muscle mass or fat distribution. CONCLUSIONS: BMI and atypical balance prescriptively predicted higher likelihood of depression remission two winters following CBT-SAD but not LT. This work informs clinical decision-making and precision medicine efforts.

Detecting Critical Decision Points during Cognitive-Behavioral Therapy and Light Therapy for Winter Depression Nonremission and Recurrence.

Using data from a clinical trial comparing cognitive-behavioral therapy (CBT-SAD) and light therapy (LT) for winter seasonal affective disorder (SAD; N = 177), we explored critical decision points, or treatment weeks, that predict likelihood of nonremission at post-treatment and depression recurrence following treatment. In receiver operator characteristic (ROC) curve analyses, we used weekly Structured Clinical Interview for the Hamilton Rating Scale for Depression-SAD Version (SIGH-SAD) scores during treatment to predict nonremission at post-treatment (Week 6) and recurrence one winter later (Winter 1), two winters later (Winter 2), and any recurrence. Although several C-statistics of ≥ .70 were found, only Week 4 SIGH-SAD scores in CBT-SAD for nonremission had enough predictive ability to inform clinical decision-making (C-statistic = .80; sensitivity = .91; specificity = .68). Week 4 of CBT-SAD may be a critical time point to identify likely nonremitters who need tailoring of intervention, based on SIGH-SAD cutpoint score ≥ 13. This study illustrates how clinical trial data can inform detecting optimal decision points in treatment for identifying patients unlikely to remit, a critical first step to developing adaptive treatment strategies using decision rules to operationalize when and for whom treatment should change to maximize clinical benefit.

Researching the Appropriateness of Care in the Complementary and Integrative Health Professions Part 4: Putting Practice Back Into Evidence-based Practice by Recruiting Clinics and Patients.

OBJECTIVES: This paper focuses on the methods of a single study, incorporating data from chiropractic clinics into an evidenced-based investigation of the appropriateness of manipulation for chronic back pain. METHODS: A cluster sample of clinics (125) from 6 sites across the United States was chosen for this observation study. Patients with chronic low-back and neck pain were recruited using iPads, completed a series of online questionnaires, and gave permission for their patient records to be scanned. Patient records for a random sample were also obtained. The RAND staff and clinic personnel collected record data. RESULTS: We obtained survey data from 2024 patients with chronic low back pain, chronic neck pain, or both. We obtained patient record data from 114 of 125 clinics. These included the records of 1475 of the individuals who had completed surveys (prospective sample), and a random sample of 2128 patients. Across 114 clinics, 22% of clinics had patient records that were fully electronic, 32% had paper files, and 46% used a combination. Of the 114 clinics, about 47% scanned the records themselves with training from RAND. We obtained a total of 3603 scanned records. The patient survey data were collected from June 2016 to February 2017, the provider surveys from June 2016 to March 2017, and the chart pull from April 2017 to December 2017. CONCLUSIONS: Clinics can be successfully recruited for practice-based studies, and patients can be recruited using iPads. Obtaining patient records presents considerable challenges, and clinics varied in whether they had electronic files, nonelectronic records, or a mixture. Clinic staff can be trained to select and scan samples of charts to comply with randomization and data protection protocols in transferring records for research purposes.

Sustaining alcohol and opioid use disorder treatment in primary care: a mixed methods study.

BACKGROUND: Efforts to integrate substance use disorder treatment into primary care settings are growing. Little is known about how well primary care settings can sustain treatment delivery to address substance use following the end of implementation support. METHODS: Data from two clinics operated by one multi-site federally qualified health center (FQHC) in the US, including administrative data, staff surveys, interviews, and focus groups, were used to gather information about changes in organizational capacity related to alcohol and opioid use disorder (AOUD) treatment delivery during and after a multi-year implementation intervention was executed. Treatment practices from the intervention period were compared to practices after the intervention period to examine whether the practices were sustained. Data from staff surveys and interviews were used to examine the factors related to sustainment. RESULTS: The two clinics sustained multiple components of AOUD care 1 year following the end of implementation support, including care coordination, psychotherapy, and medication-assisted treatment. Some of the practices were modified over time, for example, screening became less frequent by design, while use of care coordination and psychotherapy for AOUDs expanded. Participants identified staff training and funding for medications as key challenges to sustaining treatment. CONCLUSIONS: Following a multi-year implementation intervention, a large FQHC continued to deliver AOUD treatment. Access to external funding and staff support appeared to be critical elements for sustaining care over time. TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT01810159.

Researching the Appropriateness of Care in the Complementary and Integrative Health Professions Part 2: What Every Researcher and Practitioner Should Know About the Health Insurance Portability and Accountability Act and Practice-based Research in the United States.

OBJECTIVE: This paper describes a process for ensuring and documenting Health Insurance Portability and Accountability Act (HIPAA) compliance in clinical practice-based research. METHODS: The Center of Excellence for Research in Complementary and Alternative Medicine was funded by National Center for Complementary and Integrative Health to develop the methods for researching the appropriateness of care in complementary and integrative health, which previously was known as complementary and alternative medicine. We recruited 125 participating chiropractic clinics for enrolling patients and gathering their data via the online surveys. Chiropractic clinics completed the following: (1) obtained the files of patients who provided prior consent (the prospective sample), (2) obtained the files of the patients selected randomly using specified randomization procedures (the retrospective sample), and (3) transferred all patient data to the RAND Corporation via an encrypted file. RESULTS: Most of the doctors of chiropractic from clinical practices had no concerns about obtaining and transferring the files of patients who provided informed consent. However, some doctors were uneasy about allowing the researchers to access the randomly selected files of patients who had not provided prior authorization. This led us to develop a set of forms to provide clinics about HIPAA compliance. CONCLUSION: For this study, we provided clinics with information about the rules under HIPAA, demonstrated how the study complied with those rules, explained the logic behind the necessity for collecting files from both the prospective and retrospective samples, and, if requested, provided clinics with a confidentiality agreement signed by the study principal investigator and an organizational contracts representative. The process we developed may assist other complementary and integrative health researchers and practitioners in future studies.