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Cognitive Behavioral Therapy in Primary Care for Youth Declining Antidepressants: A Randomized Trial.

ABSTRACT: Health care providers have few alternatives for youth depression other than antidepressants. We examined whether brief cognitive behavioral therapy (CBT) is a viable alternative in primary care.A total of 212 adolescents aged 12 to 18 with major depression who had recently declined or quickly discontinued new antidepressant treatment were randomized to self-selected treatment as usual (TAU) control condition or TAU plus brief individual CBT. Blinded evaluators followed youth for 2 years. The primary outcome was time to major depression diagnostic recovery.CBT was superior to the control condition on the primary outcome of time to diagnostic recovery from major depression, with number needed to treat from 4 to 10 across follow-up. A similar CBT advantage was found for time to depression diagnosis response, with number needed to treat of 5 to 50 across time points. We observed a significant advantage for CBT on many secondary outcomes over the first year of follow-up but not the second year. Cohen's d effect sizes for significant continuous measures ranged from 0.28 to 0.44, in the small to medium effect range. Most TAU health care services did not differ across conditions, except for psychiatric hospitalizations, which occurred at a significantly higher rate in the control condition through the first year of follow-up.Observed results were consistent with recent meta-analyses of CBT for youth depression. The initial year of CBT superiority imparted an important clinical benefit and may reduce the risk of future recurrent depression episodes.

SUBMITTER: Clarke G

PROVIDER: S-EPMC4845864 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Cognitive Behavioral Therapy in Primary Care for Youth Declining Antidepressants: A Randomized Trial.

Clarke Gregory G DeBar Lynn L LL Pearson John A JA Dickerson John F JF Lynch Frances L FL Gullion Christina M CM Leo Michael C MC

Pediatrics 20160501 5

<h4>Background and objective</h4>Health care providers have few alternatives for youth depression other than antidepressants. We examined whether brief cognitive behavioral therapy (CBT) is a viable alternative in primary care.<h4>Methods</h4>A total of 212 adolescents aged 12 to 18 with major depression who had recently declined or quickly discontinued new antidepressant treatment were randomized to self-selected treatment as usual (TAU) control condition or TAU plus brief individual CBT. Blind ...[more]

PMID: 27244782

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Project description:BackgroundFew studies have examined the practical effectiveness and implementation potential of brief psychotherapies that integrate mental and physical health.ObjectiveTo determine whether an integrated brief cognitive behavioral therapy (bCBT), delivered by mental health providers in primary care, would improve depression, anxiety and quality of life for medically ill veterans.DesignPragmatic patient-randomized trial comparing bCBT to enhanced usual care (EUC).ParticipantsA total of 302 participants with heart failure and/or chronic obstructive pulmonary disease (COPD) with elevated symptoms of depression and/or anxiety were enrolled from two Veterans Health Administration primary care clinics.InterventionbCBT was delivered to 180 participants by staff mental health providers (n = 19). bCBT addressed physical and emotional health using a modular, skill-based approach. bCBT was delivered in person or by telephone over 4 months. Participants randomized to EUC (n = 122) received a mental health assessment documented in their medical record.Main measuresPrimary outcomes included depression (Patient Health Questionnaire) and anxiety (Beck Anxiety Inventory). Secondary outcomes included health-related quality of life. Assessments occurred at baseline, posttreatment (4 months), and 8- and 12-month follow-up.Key resultsParticipants received, on average, 3.9 bCBT sessions with 63.3% completing treatment (4+ sessions). bCBT improved symptoms of depression (p = 0.004; effect size, d = 0.33) and anxiety (p < 0.001; d = 0.37) relative to EUC at posttreatment, with effects maintained at 8 and 12 months. Health-related quality of life improved posttreatment for bCBT participants with COPD but not for heart failure. Health-related quality of life outcomes were not maintained at 12 months.ConclusionsIntegrated bCBT is acceptable to participants and providers, appears feasible for delivery in primary care settings and is effective for medically ill veterans with depression and anxiety. Improvements for both depression and anxiety were modest but persistent, and the impact on physical health outcomes was limited to shorter-term effects and COPD participants. Clinical trials.Gov identifier: NCT01149772.

Project description:BackgroundChronic pain is common, disabling, and costly. Few clinical trials have examined cognitive behavioral therapy (CBT) interventions embedded in primary care settings to improve chronic pain among those receiving long-term opioid therapy.ObjectiveTo determine the effectiveness of a group-based CBT intervention for chronic pain.DesignPragmatic, cluster randomized controlled trial. (ClinicalTrials.gov: NCT02113592).SettingKaiser Permanente health care systems in Georgia, Hawaii, and the Northwest.ParticipantsAdults (aged ≥18 years) with mixed chronic pain conditions receiving long-term opioid therapy.InterventionA CBT intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team (behaviorist, nurse, physical therapist, and pharmacist) versus usual care.MeasurementsSelf-reported pain impact (primary outcome, as measured by the PEGS scale [pain intensity and interference with enjoyment of life, general activity, and sleep]) was assessed quarterly over 12 months. Pain-related disability, satisfaction with care, and opioid and benzodiazepine use based on electronic health care data were secondary outcomes.ResultsA total of 850 patients participated, representing 106 clusters of primary care providers (mean age, 60.3 years; 67.4% women); 816 (96.0%) completed follow-up assessments. Intervention patients sustained larger reductions on all self-reported outcomes from baseline to 12-month follow-up; the change in PEGS score was -0.434 point (95% CI, -0.690 to -0.178 point) for pain impact, and the change in pain-related disability was -0.060 point (CI, -0.084 to -0.035 point). At 6 months, intervention patients reported higher satisfaction with primary care (difference, 0.230 point [CI, 0.053 to 0.406 point]) and pain services (difference, 0.336 point [CI, 0.129 to 0.543 point]). Benzodiazepine use decreased more in the intervention group (absolute risk difference, -0.055 [CI, -0.099 to -0.011]), but opioid use did not differ significantly between groups.LimitationThe inclusion of only patients with insurance in large integrated health care systems limited generalizability, and the clinical effect of change in scores is unclear.ConclusionPrimary care-based CBT, using frontline clinicians, produced modest but sustained reductions in measures of pain and pain-related disability compared with usual care but did not reduce use of opioid medication.Primary funding sourceNational Institutes of Health.

Project description:IMPORTANCE:For antidepressants, the translation of evidence of comparative effectiveness into practice is suboptimal. This deficit directly affects outcomes and quality of care for patients with depression. To overcome this problem, we developed the Depression Medication Choice (DMC) encounter decision aid, designed to help patients and clinicians consider the available antidepressants and the extent to which they improved depression and other issues important to patients. OBJECTIVE:Estimate the effect of DMC on quality of the decision-making process and depression outcomes. DESIGN, SETTING, AND PARTICIPANTS:We conducted a cluster randomized trial of adults with moderate to severe depression considering treatment with an antidepressant. Primary care practices in 10 rural, suburban, and urban primary care practices across Minnesota and Wisconsin were randomly allocated to treatment of depression with or without use of the DMC decision aid. INTERVENTION:Depression Medication Choice, a series of cards, each highlighting the effect of the available options on an issue of importance to patients for use during face-to-face consultations. MAIN OUTCOMES AND MEASURES:Decision-making quality as judged by patient knowledge and involvement in decision making, patient and clinician decisional comfort (Decisional Conflict Scale) and satisfaction, encounter duration, medication adherence, depression symptoms, and the Patient Health Questionnaire for depression (PHQ-9). RESULTS:We enrolled 117 clinicians and 301 patients (67% women; mean [SD] age, 44 [15] years; mean [SD] PHQ-9 score, 15 [4]) into the trial. Compared with usual care (UC), use of DMC significantly improved patients' decisional comfort (DMC, 80% vs UC, 75%; P = .02), knowledge (DMC, 65% vs UC, 56%; P =?.03), satisfaction (risk ratio [RR], from 1.25 [P =?.81] to RR, 2.4 [P =?.002] depending on satisfaction domain), and involvement (DMC, 47% vs UC, 33%; P<.001). It also improved clinicians' decisional comfort (DMC, 80% vs UC, 68%; P <?.001) and satisfaction (RR, 1.64; P =?.02). There were no differences in encounter duration, medication adherence, or improvement of depression control between arms. CONCLUSIONS AND RELEVANCE:The DMC decision aid helped primary care clinicians and patients with moderate to severe depression select antidepressants together, improving the decision-making process without extending the visit. On the other hand, DMC had no discernible effect on medication adherence or depression outcomes. By translating comparative effectiveness into patient-centered care, use of DMC improved the quality of primary care for patients with depression. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT01502891.

Project description:BACKGROUND: Despite the availability of evidence-based psychotherapies for depression and anxiety, they are underused in non-mental health specialty settings such as primary care. Hybrid effectiveness-implementation designs have the potential to evaluate clinical and implementation outcomes of evidence-based psychotherapies to improve their translation into routine clinical care practices. METHODS: This protocol article discusses the study methodology and implementation strategies employed in an ongoing, hybrid, type 2 randomized controlled trial with two primary aims: (1) to determine whether a brief, manualized cognitive behavioral therapy administered by Veterans Affairs Primary Care Mental Health Integration program clinicians is effective in treating depression and anxiety in a sample of medically ill (chronic cardiopulmonary diseases) primary care patients and (2) to examine the acceptability, feasibility, and preliminary outcomes of a focused implementation strategy on improving adoption and fidelity of brief cognitive behavioral therapy at two Primary Care-Mental Health Integration clinics. The study uses a hybrid type 2 effectiveness/implementation design to simultaneously test clinical effectiveness and to collect pilot data on a multifaceted implementation strategy that includes an online training program, audit and feedback of session content, and internal and external facilitation. Additionally, the study engages the participation of an advisory council consisting of stakeholders from Primary Care-Mental Health Integration, as well as regional and national mental health leaders within the Veterans Administration. It targets recruitment of 320 participants randomized to brief cognitive behavioral therapy (n?=?200) or usual care (n?=?120). Both effectiveness and implementation outcomes are being assessed using mixed methods, including quantitative evaluation (e.g., intent-to-treat analyses across multiple time points) and qualitative methods (e.g., focus interviews and surveys from patients and providers). Patient-effectiveness outcomes include measures of depression, anxiety, and physical health functioning using blinded independent evaluators. Implementation outcomes include patient engagement and adherence and clinician brief cognitive behavioral therapy adoption and fidelity. CONCLUSIONS: Hybrid designs are needed to advance clinical effectiveness and implementation knowledge to improve healthcare practices. The current article describes the rationale and challenges associated with the use of a hybrid design for the study of brief cognitive behavioral therapy in primary care. Although trade-offs exist between scientific control and external validity, hybrid designs are part of an emerging approach that has the potential to rapidly advance both science and practice. TRIAL REGISTRATION: NCT01149772 at http://www.clinicaltrials.gov/ct2/show/NCT01149772.

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Cognitive Behavioral Therapy in Primary Care for Youth Declining Antidepressants: A Randomized Trial.

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Cognitive Behavioral Therapy in Primary Care for Youth Declining Antidepressants: A Randomized Trial.

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