Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy and Mechanisms of a Behavioral Therapy for Insomnia Co-existing With COPD
Brief Summary: Difficulty falling asleep, staying asleep or poor quality sleep (insomnia) is common in people with chronic obstructive pulmonary disease. Insomnia is related to greater mortality, with four times the risk of mortality for sleep times \< 300 minutes. Insomnia is also related to greater morbidity, with 75% greater health care costs than people without insomnia. However, insomnia medications are used with caution in COPD due to potential adverse effects. Common features of COPD such as dyspnea, chronic inflammation, anxiety and depression also affect insomnia and can interfere with therapy outcomes. While cognitive behavioral therapy for insomnia (CBT-I), a therapy that provides guidance on changing unhelpful sleep-related beliefs and behavior, is effective for people with primary insomnia and people with other chronic illnesses, the efficacy and mechanisms of action of such a therapy are yet unclear in people with both insomnia and COPD. The objective in this application is to rigorously test efficacy of two components of insomnia therapy - CBT-I and COPD education (COPD-ED) - in people with coexisting insomnia and COPD, and to identify mechanisms responsible for therapy outcomes. The central hypothesis is that both CBT-I and COPD-ED will have positive, lasting effects on objectively and subjectively measured insomnia and fatigue. The rationale for the proposed study is that once the efficacy and mechanisms of CBT-I and COPD-ED are known, new and innovative approaches for insomnia coexisting with COPD can be developed, thereby leading to longer, higher quality and more productive lives for people with COPD, and reduced societal cost due to the effects of insomnia. The investigators plan to test our central hypothesis by completing a randomized controlled comparison of CBT-I, COPD-ED and non-COPD, non-sleep health education attention control (AC) using a highly efficient 4-group design. Arm 1 comprises 6 weekly sessions of CBT-I+AC; Arm 2=6 sessions of COPD-ED+AC; Arm 3=CBT-I+COPD-ED; and Arm 4=AC. This design will allow completion of the following Specific Aims: 1. Determine the efficacy of individual treatment components, CBT-I and COPD-ED, on insomnia and fatigue. 2. Define mechanistic contributors to the outcomes after CBT-I and COPD-ED. The research proposed in this application is innovative because it represents a new and substantive departure from the usual insomnia therapy, namely by testing traditional CBT-I with education to enhance outcomes.


Options:
A: Arm Label: CHF patients, IVR-Enhanced Care; Type: EXPERIMENTAL; Interventions: Behavioral: IVR-Enhanced Care | Arm Label: COPD patients, IVR-Enhanced Care; Type: EXPERIMENTAL; Interventions: Behavioral: IVR-Enhanced Care | Arm Label: CHF patients, Usual Discharge Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: COPD patients, Usual Discharge Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: IVR-Enhanced Care; Assigned to Arm(s): CHF patients, IVR-Enhanced Care, COPD patients, IVR-Enhanced Care
B: Arm Label: Case Management; Type: EXPERIMENTAL; Interventions: Behavioral: 40 minute standardized education session, Behavioral: Individualized action plan, Behavioral: Individualized care plan, Behavioral: Standardized reinforcement/motivational interviewing and action plan teach-back sessions, Behavioral: Tele-home monitoring, Behavioral: Coordinated and improved communication, Behavioral: Priority access, Behavioral: Dictated patient summary, Behavioral: in-hospital rehabilitation/self-management program, Behavioral: Smoking cessation | Arm Label: Usual care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Dictated patient summary, Behavioral: in-hospital rehabilitation/self-management program, Behavioral: Smoking cessation, Behavioral: Action plan Respirologist, Behavioral: Web based self management materials | Intervention Type: BEHAVIORAL; Name: 40 minute standardized education session; Assigned to Arm(s): Case Management | Intervention Type: BEHAVIORAL; Name: Individualized action plan; Assigned to Arm(s): Case Management | Intervention Type: BEHAVIORAL; Name: Individualized care plan; Assigned to Arm(s): Case Management | Intervention Type: BEHAVIORAL; Name: Standardized reinforcement/motivational interviewing and action plan teach-back sessions; Assigned to Arm(s): Case Management | Intervention Type: BEHAVIORAL; Name: Tele-home monitoring; Assigned to Arm(s): Case Management | Intervention Type: BEHAVIORAL; Name: Coordinated and improved communication; Assigned to Arm(s): Case Management | Intervention Type: BEHAVIORAL; Name: Priority access; Assigned to Arm(s): Case Management | Intervention Type: BEHAVIORAL; Name: Dictated patient summary; Assigned to Arm(s): Case Management, Usual care | Intervention Type: BEHAVIORAL; Name: in-hospital rehabilitation/self-management program; Assigned to Arm(s): Case Management, Usual care | Intervention Type: BEHAVIORAL; Name: Smoking cessation; Assigned to Arm(s): Case Management, Usual care | Intervention Type: BEHAVIORAL; Name: Action plan Respirologist; Assigned to Arm(s): Usual care | Intervention Type: BEHAVIORAL; Name: Web based self management materials; Assigned to Arm(s): Usual care
C: Arm Label: Cognitive Behavioral Therapy (CBT-I); Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Behavioral Therapy for Insomnia | Arm Label: CBT-I + COPD-ED; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Behavioral Therapy for Insomnia, Behavioral: COPD Education | Arm Label: COPD Education (COPD-ED); Type: EXPERIMENTAL; Interventions: Behavioral: COPD Education | Arm Label: Attention Control (AC); Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Attention Control | Intervention Type: BEHAVIORAL; Name: Cognitive Behavioral Therapy for Insomnia; Assigned to Arm(s): CBT-I + COPD-ED, Cognitive Behavioral Therapy (CBT-I) | Intervention Type: BEHAVIORAL; Name: COPD Education; Assigned to Arm(s): CBT-I + COPD-ED, COPD Education (COPD-ED) | Intervention Type: BEHAVIORAL; Name: Attention Control; Assigned to Arm(s): Attention Control (AC)
D: Intervention Type: BEHAVIORAL; Name: Self-management of chronic illness; Assigned to Arm(s): N/A

Answer: C