NCT01987089

The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse

Completed NA Results posted Last updated 7 August 2020

What this trial tests

NA trial testing Cognitive Behavioral Therapy for Insomnia (CBT-I) in Insomnia in 63 participants. Completed in 30 March 2020.

Timeline

15 August 2014

Primary endpoint
23 May 2019

30 March 2020

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	63
Start date	15 August 2014
Primary completion	23 May 2019
Estimated completion	30 March 2020
Sites	1 location across United States

Drugs / interventions tested

• Cognitive Behavioral Therapy for Insomnia (CBT-I)

Conditions studied

• Insomnia — all drugs for Insomnia →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 21 to 70, any sex, with Insomnia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Insomnia Severity Index - Total Score Primary · 8 weeks, 3 months post-treatment, and 6 months post-treatment

Insomnia Severity Index (ISI): This 7-item (0-4 Likert scales) measure yields a total score of 28. The norms for the scale are as follows: 0-7 represents no clinically significant insomnia; 8-14 represents sub threshold insomnia; 15-21 represents clinical insomnia (moderate severity); 21-28 represents clinical insomnia (severe). The scale provides a measure of severity of insomnia (overall), a measure of insomnia subtype, a measure of the diurnal effects of insomnia, and a measure of sleep "satisfaction". The ISI will be completed at baseline and for all the subsequent study-related visits.

Change at week 8 (Vs baseline)

Group	Value	95% CI
Cognitive Behavioral Therapy for Insomnia (CBT-I)	-10.71	-13.07 – -8.10
Quasi Desensitization Therapy (QDT)	-8.84	-10.82 – -6.84

Change at 3 mo post-treatment F/U (Vs baseline)

Group	Value	95% CI
Cognitive Behavioral Therapy for Insomnia (CBT-I)	-8.51	-11.21 – -5.78
Quasi Desensitization Therapy (QDT)	-9.30	-11.43 – -7.26

Change at 6 mo post-treatment F/U (Vs baseline)

Group	Value	95% CI
Cognitive Behavioral Therapy for Insomnia (CBT-I)	-6.89	-9.48 – -4.29
Quasi Desensitization Therapy (QDT)	-7.29	-9.50 – -4.63

Change in Percent Days Abstinent (PDA) on the Time Line Follow Back Measure Primary · 8 weeks, 3 months post-treatment and 6-months post-treatment

Time Line Follow Back measure (TLFB): The TLFB provides assessment of drinking using a calendar format for the number of standard alcoholic beverages consumed per day. A standard drink, as defined by the National Institutes of Health, is 12 oz of regular beer, 5 oz of regular wine, or 1.5 oz of distilled spirits (e.g. whiskey). Numerous indices may be derived from the TLFB, such as the Percent Days Abstinent (PDA) proposed in this study. The PDA is derived as the percentage of days an individual reports being abstinent from alcohol within a given assessment time period.

Change at week 8 (Vs baseline)

Group	Value	95% CI
Cognitive Behavioral Therapy for Insomnia (CBT-I)	0.56	0.44 – 0.68
Quasi Desensitization Therapy (QDT)	0.67	0.55 – 0.80

Change at 3 mo post-treatment F/U (Vs baseline)

Group	Value	95% CI
Cognitive Behavioral Therapy for Insomnia (CBT-I)	0.51	0.38 – 0.63
Quasi Desensitization Therapy (QDT)	0.61	0.50 – 0.74

Change at 6 mo post-treatment F/U (Vs baseline)

Group	Value	95% CI
Cognitive Behavioral Therapy for Insomnia (CBT-I)	0.48	0.36 – 0.60
Quasi Desensitization Therapy (QDT)	0.62	0.50 – 0.74

Change in PCS From the Short Form - 12 Item (SF-12) Measure Secondary · 8 weeks, 3 months post-treatment, and 6 months post-treatment

The Physical Component Summary (PCS) scale has a range from 0 (indicating the lowest level of health) to 100 (indicating the best level of health).

Change at week 8 (Vs baseline)

Group	Value	95% CI
Cognitive Behavioral Therapy for Insomnia (CBT-I)	-1.00	-3.29 – 1.30
Quasi Desensitization Therapy (QDT)	0.48	-2.70 – 3.80

Change at 3 mo post-treatment F/U (Vs baseline)

Group	Value	95% CI
Cognitive Behavioral Therapy for Insomnia (CBT-I)	-1.69	-5.13 – 1.59
Quasi Desensitization Therapy (QDT)	0.54	-2.21 – 3.13

Change at 6 mo post-treatment F/U (Vs baseline)

Group	Value	95% CI
Cognitive Behavioral Therapy for Insomnia (CBT-I)	-1.18	-3.10 – 1.00
Quasi Desensitization Therapy (QDT)	-0.25	-3.41 – 3.18

Change in MCS From the Short Form - 12 Item (SF-12) Measure Secondary · 8 weeks, 3 months post-treatment, and 6 months post-treatment

The Mental Component Summary (MCS) scale has a range from 0 (indicating the lowest level of health) to 100 (indicating the best level of health).

Change at week 8 (Vs baseline)

Group	Value	95% CI
Cognitive Behavioral Therapy for Insomnia (CBT-I)	-3.06	-8.04 – 1.71
Quasi Desensitization Therapy (QDT)	-1.90	-5.92 – 2.16

Change at 3 mo post-treatment F/U (Vs baseline)

Group	Value	95% CI
Cognitive Behavioral Therapy for Insomnia (CBT-I)	-2.60	-7.83 – 2.42
Quasi Desensitization Therapy (QDT)	1.12	-2.80 – 5.02

Change at 6 mo post-treatment F/U (Vs baseline)

Group	Value	95% CI
Cognitive Behavioral Therapy for Insomnia (CBT-I)	-2.07	-5.90 – 1.64
Quasi Desensitization Therapy (QDT)	0.89	-4.32 – 5.84

Adverse events — posted to ClinicalTrials.gov

Time frame: 9 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Serious: 7/31 (23%)

Deaths: 0/31

Quasi Desensitization Therapy (QDT)

Serious: 3/32 (9%)

Deaths: 0/32

Serious adverse events (5 terms)

Reaction	System	Cognitive Behavioral Thera…	Quasi Desensitization Ther…
Alcohol detoxification	Nervous system disorders	—	—
Cerebrovascular Accident (CVA)	Nervous system disorders	—	—
Abdominal Pain	Gastrointestinal disorders	—	—
Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—
Residential Psychiatric Treatment	Nervous system disorders	—	—

Most-reported serious reactions: Alcohol detoxification, Cerebrovascular Accident (CVA), Abdominal Pain, Pneumonia, Residential Psychiatric Treatment.

Data from ClinicalTrials.gov NCT01987089 adverse events section.

Sponsor's own description

Insomnia is a highly prevalent disorder in those recovering from alcoholism. It has been associated with anxiety and depressive symptoms, as well as an increased risk of relapse back to the drinking.

Cognitive Behavioral Therapy for Insomnia (CBT-I), a non-pharmacologic approach is the recommended standard of care for insomnia. Some preliminary studies have shown that CBT-I may be efficacious for insomnia during recovery.

The current study proposes to use a standard 8-week CBT-I to treat the insomnia with a post-treatment follow-up at 3- and 6-months (after treatment). Further, it will evaluate if an improvement in the insomnia is associated with an improvement in the underling alcoholism and the daytime functioning. On an exploratory basis, the association of a first-degree family history of alcoholism with the insomnia severity and treatment response will also be evaluated.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.