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Hybrid Cognitive-Behavioral Therapy Intervention for Adolescents With Co-Occurring Migraine and Insomnia: A Single-Arm Pilot Trial.

ABSTRACT: OBJECTIVE:This study aimed to evaluate feasibility and acceptability of a hybrid cognitive-behavioral therapy intervention for adolescents with co-occurring migraine and insomnia. BACKGROUND:Many youth with chronic migraine have co-occurring insomnia. Little research has been conducted to evaluate behavioral treatments for insomnia in youth with migraine. DESIGN AND METHODS:We conducted a single-arm pilot trial to evaluate the feasibility and acceptability of delivering cognitive-behavioral therapy for insomnia to 21 youth (mean age 15.5, standard deviation 1.6) with co-occurring chronic migraine and insomnia. Adolescents completed up to 6 individual treatment sessions over 6 to 12 weeks, and 1 booster session 1 month later. Assessments included a prospective 7-day headache and sleep diary, and self-report measures of insomnia, sleep quality, sleep habits, and activity limitations at pre-treatment, immediate post-treatment, and 3-month follow-up. RESULTS:Adolescents demonstrated good treatment adherence and families rated the intervention as highly acceptable. Preliminary analyses indicated improvements from pre-treatment to post-treatment in primary outcomes of headache days (M = 4.7, SD = 2.1 vs M = 2.8, SD = 2.7) and insomnia symptoms (M = 16.9, SD = 5.2 vs M = 9.5, SD = 6.2), which were maintained at 3-month follow-up (M = 2.7, SD = 2.8; M = 9.3, SD = 5.0, respectively). We also found improvements in secondary outcomes of pain-related activity limitations as well as sleep quality, sleep hygiene, and sleep patterns. CONCLUSIONS:These preliminary data indicate that hybrid cognitive-behavioral therapy is feasible and acceptable for youth with co-occurring chronic migraine and insomnia. Future randomized controlled trials are needed to test treatment efficacy on migraine, sleep, and functional outcomes. ClinicalTrials.gov Identifier: NCT03137147.

SUBMITTER: Law EF

PROVIDER: S-EPMC6116549 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Hybrid Cognitive-Behavioral Therapy Intervention for Adolescents With Co-Occurring Migraine and Insomnia: A Single-Arm Pilot Trial.

Law Emily F EF Wan Tham See S Aaron Rachel V RV Dudeney Joanne J Palermo Tonya M TM

Headache 20180701 7

<h4>Objective</h4>This study aimed to evaluate feasibility and acceptability of a hybrid cognitive-behavioral therapy intervention for adolescents with co-occurring migraine and insomnia.<h4>Background</h4>Many youth with chronic migraine have co-occurring insomnia. Little research has been conducted to evaluate behavioral treatments for insomnia in youth with migraine.<h4>Design and methods</h4>We conducted a single-arm pilot trial to evaluate the feasibility and acceptability of delivering cog ...[more]

PMID: 30152164

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Project description:BACKGROUND:Evidence-based treatment for co-occurring disorders is needed within programs that serve homeless Veterans to assist with increasing engagement in care and to prevent future housing loss. A specialized co-occurring disorders treatment engagement intervention called Maintaining Independence and Sobriety Through Systems Integration, Outreach and Networking - Veterans Edition (MISSION-Vet) was implemented within the Housing and Urban Development - Veterans Affairs Supportive Housing (HUD-VASH) Programs with and without an implementation strategy called Getting To Outcomes (GTO). While implementation was modest for the GTO group, no one adopted MISSION in the non-GTO group. This paper reports Veteran level outcome data on treatment engagement and select behavioral health outcomes for Veterans exposed to the MISSION-Vet model compared to Veterans without access to MISSION-Vet. METHODS:This hybrid Type III trial compared 81 Veterans in the GTO group to a similar group of 87 Veterans with mental health and substance use disorders from the caseload of staff in the non-GTO group. Comparisons were made on treatment engagement, negative housing exits, drug and alcohol abuse, inpatient hospitalizations, emergency department visits and income level over time, using mixed-effect or Cox regression models. RESULTS:Treatment engagement, as measured by the overall number of case manager contacts with Veterans and others (e.g. family members, health providers), was significantly higher among Veterans in the GTO group (B?=?2.30, p?=?.04). Supplemental exploratory analyses between Veterans who received "higher" and "lower" intensity MISSION-Vet services in the GTO group failed to show differences in alcohol and drug use, inpatient hospitalization and emergency department use. CONCLUSIONS:Despite modest MISSION-Vet fidelity among staff treating Veterans in the GTO group, differences were found in treatment engagement. However, this study failed to show differences in alcohol use, drug use, mental health hospitalizations and negative housing exits over time among those Veterans receiving higher intensity MISSION-Vet services versus low intensity services. This project suggests that MISSION-Vet could be used in HUD-VASH to increase engagement among Veterans struggling with homelessness, a group often disconnected from care. TRIAL REGISTRATION:Clinicaltrials.gov, registration number: NCT01430741 , registered July 26, 2011.

Project description:Insomnia is a major health problem with significant psychological, health, and economic consequences. However, availability of one of the most effective insomnia treatments, cognitive behavioral therapy, is significantly limited. The Internet may be a key conduit for delivering this intervention.To evaluate the efficacy of a structured behavioral Internet intervention for adults with insomnia.Forty-five adults were randomly assigned to an Internet intervention (n = 22) or wait-list control group (n = 23). Forty-four eligible participants (mean [SD] age, 44.86 [11.03] years; 34 women) who had a history of sleep difficulties longer than 10 years on average (mean [SD], 10.59 [8.89] years) were included in the analyses.The Internet intervention is based on well-established face-to-face cognitive behavioral therapy incorporating the primary components of sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention.The Insomnia Severity Index and daily sleep diary data were used to determine changes in insomnia severity and the main sleep variables, including wake after sleep onset and sleep efficiency.Intention-to-treat analyses showed that scores on the Insomnia Severity Index significantly improved from 15.73 (95% confidence interval [CI], 14.07 to 17.39) to 6.59 (95% CI, 4.73 to 8.45) for the Internet group but did not change for the control group (16.27 [95% CI, 14.61 to 17.94] to 15.50 [95% CI, 13.64 to 17.36]) (F(1,42) = 29.64; P < .001). The Internet group maintained their gains at the 6-month follow-up. Internet participants also achieved significant decreases in wake after sleep onset (55% [95% CI, 34% to 76%]) and increases in sleep efficiency (16% [95% CI, 9% to 22%]) compared with the nonsignificant control group changes of wake after sleep onset (8% [95% CI, -17% to 33%) and sleep efficiency (3%; 95% CI, -4% to 9%).Participants who received the Internet intervention for insomnia significantly improved their sleep, whereas the control group did not have a significant change. The Internet appears to have considerable potential in delivering a structured behavioral program for insomnia.clinicaltrials.gov Identifier: NCT00328250.

Project description:BackgroundObstructive sleep apnea (OSA) and insomnia are commonly co-occurring conditions that amplify morbidity and complicates the management of affected patients. Unfortunately, previous research provides limited guidance as to what constitutes the best and most practical management approach for this comorbid patient group. Some preliminary studies show that when cognitive behavioral insomnia therapy (CBT-I) is combined with standard OSA therapies for these patients, outcomes are improved. However, the dearth of trained providers capable of delivering CBT-I has long served as a pragmatic barrier to the widespread use of this therapy in clinical practice. The emergence of sophisticated online CBT-I (OCBT-I) programs could improve access, showing promising reductions in insomnia severity. Given its putative scalability and apparent efficacy, some have argued OCBT-I should represent a 1st-stage intervention in a broader stepped care model that allocates more intensive and less assessable therapist-delivered CBT-I (TCBT-I) only to those who show an inadequate response to lower intensity OCBT-I. However, the efficacy of OCBT-I as a 1st-stage therapy within a broader stepped care management strategy for insomnia comorbid with OSA has yet to be tested with comorbid OSA/insomnia patients.Methods/designThis dual-site randomized clinical trial will use a Sequential Multiple Assignment Randomized Trial (SMART) design to test a stepped care model relative to standard positive airway pressure (PAP) therapy and determine if (1) augmentation of PAP therapy with OCBT-I improves short-term outcomes of comorbid OSA/insomnia and (2) providing a higher intensity 2nd-stage CBT-I to patients who show sub-optimal short-term outcomes with OCBT-I+PAP improves short and longer-term outcomes. After completing baseline assessment, the comorbid OSA/insomnia patients enrolled will be randomized to a 1st-stage therapy that includes usual care PAP + OCBT-I or UC (usual care PAP + sleep hygiene education). Insomnia will be reassessed after 8 weeks. OCBT-I recipients who meet "remission" criteria (defined as an Insomnia Severity Index score < 10) will continue PAP but will not be offered any additional insomnia intervention and will complete study outcome measures again after an additional 8 weeks and at 3 and 6 month follow-ups. OCBT-I recipients classified as "unremitted" after 8 weeks of treatment will be re-randomized to a 2nd-stage treatment consisting of continued, extended access to OCBT-I or a switch to TCBT-I. Those receiving the 2nd-stage intervention as well as the UC group will be reassessed after another 8 weeks and at 3- and 6-month follow-up time points. The primary outcome will be insomnia remission. Secondary outcomes will include subjective and objective sleep data, including sleep time, sleep efficiency, fatigue ratings, PAP adherence, sleepiness ratings, sleep/wake functioning ratings, and objective daytime alertness.DiscussionThis study will provide new information about optimal interventions for patients with comorbid OSA and insomnia to inform future clinical decision-making processes.Trial registrationClinicalTrials.gov, NCT03109210 , registered on April 12, 2017, prospectively registered.

Dataset Information

Hybrid Cognitive-Behavioral Therapy Intervention for Adolescents With Co-Occurring Migraine and Insomnia: A Single-Arm Pilot Trial.

Publications

Hybrid Cognitive-Behavioral Therapy Intervention for Adolescents With Co-Occurring Migraine and Insomnia: A Single-Arm Pilot Trial.

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