Evidence map›Paper›PMID 35057834›Full record

ArticleTrials2022

Telemedicine-delivered cognitive-behavioral therapy for insomnia in alcohol use disorder (AUD): study protocol for a randomized controlled trial.

J Todd Arnedt, M Elizabeth Cardoni, Deirdre A Conroy, Mandilyn Graham, Sajni Amin, Kipling M Bohnert, Andrew D Krystal, Mark A Ilgen

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 1 country.

J Todd ArnedtSleep and Circadian Research Laboratory, Department of Psychiatry, Michigan Medicine, University of Michigan, 4250 Plymouth Road, Ann Arbor, MI, 48109-2700, USA. tarnedt@med.umich.edu.ORCID http://orcid.org/0000-0002-5084-9331
M Elizabeth CardoniSleep and Circadian Research Laboratory, Department of Psychiatry, Michigan Medicine, University of Michigan, 4250 Plymouth Road, Ann Arbor, MI, 48109-2700, USA.
Deirdre A ConroySleep and Circadian Research Laboratory, Department of Psychiatry, Michigan Medicine, University of Michigan, 4250 Plymouth Road, Ann Arbor, MI, 48109-2700, USA.
Mandilyn GrahamSleep and Circadian Research Laboratory, Department of Psychiatry, Michigan Medicine, University of Michigan, 4250 Plymouth Road, Ann Arbor, MI, 48109-2700, USA.
Sajni AminSleep and Circadian Research Laboratory, Department of Psychiatry, Michigan Medicine, University of Michigan, 4250 Plymouth Road, Ann Arbor, MI, 48109-2700, USA.
Kipling M BohnertDepartment of Epidemiology and Biostatistics, Michigan State University, East Lansing, USA.
Andrew D KrystalUCSF Weill Institute for Neurosciences, University of California San Francisco, San Francisco, USA.
Mark A IlgenUniversity of Michigan Addiction Treatment Services, Department of Psychiatry, Michigan Medicine, University of Michigan, Ann Arbor, USA.
Michigan Medicine · USMichigan State University · USUniversity of California, San Francisco · USUniversity of Michigan · US

Funding

Targeting sleep homeostasis to improve alcohol use disorder treatment outcomesR01AA028158 · NIAAA · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ARNEDT, J. TODD · 2019 to 2023
$2.6M
HSRD VA IK6 HX002841NIAAA NIH HHS R01 AA028158
6 · The paper itself

Abstract

backgroundAlcohol use disorder (AUD) is a leading preventable cause of morbidity and mortality, but relapse rates are high even with available treatments. Insomnia is a robust predictor of relapse and pilot studies have shown that CBT for insomnia improves insomnia and daytime functioning in adults with AUD and insomnia. The impact of CBT for insomnia on relapse, however, is unclear. This trial will compare telemedicine-delivered CBT for insomnia (CBT-TM) with sleep hygiene education (SHE-TM) on improving insomnia/sleep, daytime symptom, and drinking outcomes in treatment-seeking AUD adults with insomnia. The study will also determine the effects of treatment on sleep mechanisms and their association with clinical outcomes.

methodsThis is a single-site randomized controlled trial with planned enrollment of 150 adults meeting criteria for both AUD and chronic insomnia. Eligible participants will be randomized 1:1 to 6 sessions of telemedicine-delivered Cognitive Behavioral Therapy for Insomnia (CBT-TM) or Sleep Hygiene Education (SHE-TM) with clinical assessments conducted at pre-treatment, post- treatment, and at 3, 6, and 12 months post-treatment. Overnight polysomnography will be conducted before and after treatment. Primary clinical outcomes will include post-treatment scores on the Insomnia Severity Index and the General Fatigue subscale of the Multidisciplinary Fatigue Inventory, and the percent of days abstinent (PDA) on the interview-administered Time Line Follow Back. EEG delta activity, derived from overnight polysomnography, will be the primary endpoint to assess the sleep homeostasis mechanism. DISCUSSION: This adequately powered randomized controlled trial will provide clinically relevant information about whether targeting insomnia is effective for improving treatment outcomes among treatment-seeking adults with AUD. Additionally, the study will offer new scientific insights on the impact of an evidence-based non-medication treatment for insomnia on a candidate mechanism of sleep dysfunction in this population - sleep homeostasis.

trial registrationCClinicalTrials.gov NCT # 04457674 . Registered on 07 July 2020.

Indexed as

AlcoholismCognitive Behavioral TherapySleep Initiation and Maintenance DisordersTelemedicineAdultHumansRandomized Controlled Trials as TopicSleepAlcohol use disorder, Insomnia, Non-medication treatment, Relapse

Identifiers

PMID35057834
PMCPMC8771184
OpenAlexW4225813066

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.