InsomniaNCT01603381
The Effect of Family History on Insomnia During Sobriety in Alcoholics
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) in people with Insomnia, run by Corporal Michael J. Crescenz VA Medical Center at 1 site in United States.
Trial summary
The investigators intend to assess the following: the efficacy of CBTi in treating insomnia during recovery, does a family history of alcoholism moderate the insomnia symptoms, does an improvement in insomnia lead to a decrease in impulsivity. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Insomnia
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of insomnia currently
- DSM IV diagnosis of alcohol dependence within the past year
- Not in acute alcohol withdrawal and within a year of sobriety from alcoholism
- Patients with moderate-severe sleep apnea compliant on their PAP device
- Can speak, understand and print in English.
- Is capable of giving written informed consent.
Who cannot join
- Dependence on psychoactive substance (excluding alcohol, nicotine and cannabis) in the past 12 months, or evidence of chronic opiate use.
- Unstable/serious psychiatric condition e.g. schizophrenia, bipolar disorder.
- Unstable or serious medical/neurologic illness
- Severe cognitive impairment
- Untreated moderate - severe obstructive sleep apnea
Trial locations and contacts
1 site in 1 country.
United States1 site
Philadelphia Veterans Affairs Medical Center
Philadelphia, Pennsylvania, 19104
About this study
The investigators intend to assess the following:
- the efficacy of CBTi in treating insomnia during recovery,
- does a family history of alcoholism moderate the insomnia symptoms,
- does an improvement in insomnia lead to a decrease in impulsivity.
Read the detailed description
The primary goals of this pilot study are the following:
- to assess for the difference in improvement insomnia, after 8 weeks of treatment with recommended CBTi, in Veterans with alcohol dependence during early recovery,
The secondary goals include the following:
- to assess for any change in the alcohol consumption indices between the groups after 8 weeks of CBTi,
- to assess for change in psychiatric symptoms of mood and anxiety across the groups,
- to assess for differences in insomnia in subjects, with and without a first degree family history of alcohol dependence,
- to evaluate for any change in impulsivity-related measure with insomnia treatment.
- Conditions
- Insomnia
- Being tested
- Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Insomnia (CBT-I)Behavioural
Behavioral management of insomnia
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Experimental | Cognitive Behavioral Therapy for Insomnia Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) |
| Monitor Only (M.O.) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index total score
There will be post-treatment follow up at 3 months and 6 months.
Measured: 8 weeks.
Secondary outcomes (1)
Time Line Follow Back measure
There will be post-study follow-up at 3 months and 6 months also.
Measured: 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporal Michael J. Crescenz VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Subhajit Chakravorty, Corporal Michael J. Crescenz VA Medical Center
- Investigators
- Subhajit Chakravorty, M.D., Principal investigator, Corporal Michael J. Crescenz VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603381
- Sponsor's protocol ID
- 01257
- Status last verified
- Oct 2016
- First submitted
- 3 Feb 2012
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Chakravorty S, Morales KH, Arnedt JT, Perlis ML, Oslin DW, Findley JC, Kranzler HR. Cognitive Behavioral Therapy for Insomnia in Alcohol-Dependent Veterans: A Randomized, Controlled Pilot Study. Alcohol Clin Exp Res. 2019 Jun;43(6):1244-1253. doi: 10.1111/acer.14030. Epub 2019 Apr 29.
PubMed 30912860
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Family History on Insomnia During Sobriety in Alcoholics
- ClinicalTrials.gov ID
- NCT01603381
- Acronym / sponsor ID
- 01257
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Corporal Michael J. Crescenz VA Medical CenterUS federal agency
- Study start
- Jun 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators intend to assess the following:
- the efficacy of CBTi in treating insomnia during recovery,
- does a family history of alcoholism moderate the insomnia symptoms,
- does an improvement in insomnia lead to a decrease in impulsivity.
Detailed description
The primary goals of this pilot study are the following:
- to assess for the difference in improvement insomnia, after 8 weeks of treatment with recommended CBTi, in Veterans with alcohol dependence during early recovery,
The secondary goals include the following:
- to assess for any change in the alcohol consumption indices between the groups after 8 weeks of CBTi,
- to assess for change in psychiatric symptoms of mood and anxiety across the groups,
- to assess for differences in insomnia in subjects, with and without a first degree family history of alcohol dependence,
- to evaluate for any change in impulsivity-related measure with insomnia treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-I | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)Cognitive Behavioral Therapy for Insomnia |
| Monitor Only (M.O.) | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Presence of insomnia currently
- DSM IV diagnosis of alcohol dependence within the past year
- Not in acute alcohol withdrawal and within a year of sobriety from alcoholism
- Patients with moderate-severe sleep apnea compliant on their PAP device
- Can speak, understand and print in English.
Key exclusion criteria (5 listed)
- Dependence on psychoactive substance (excluding alcohol, nicotine and cannabis) in the past 12 months, or evidence of chronic opiate use.
- Unstable/serious psychiatric condition e.g. schizophrenia, bipolar disorder.
- Unstable or serious medical/neurologic illness
- Severe cognitive impairment
- Untreated moderate - severe obstructive sleep apnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I)Behavioral management of insomnia | Behavioural | CBT-I |
Primary outcome
Insomnia Severity Index total score
Time frame: 8 weeks.
There will be post-treatment follow up at 3 months and 6 months.
1 secondary outcome
Time Line Follow Back measure
Time frame: 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Derived from this study: PubMed 30912860Chakravorty S, Morales KH, Arnedt JT, Perlis ML, Oslin DW, Findley JC, Kranzler HR. Cognitive Behavioral Therapy for Insomnia in Alcohol-Dependent Veterans: A Randomized, Controlled Pilot Study. Alcohol Clin Exp Res. 2019 Jun;43(6):1244-1253. doi: 10.1111/acer.14030. Epub 2019 Apr 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Subhajit Chakravorty, M.D. principal investigator
Corporal Michael J. Crescenz VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) in people with Insomnia, run by Corporal Michael J. Crescenz VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index total score (time frame: 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01603381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2016.