Comparison of Efficacy of Behavioral Approaches for Treatment of Insomnia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-05

Study Completion Date

2022-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study compares the efficacy of four different types (Cognitive Behavior Therapy for Insomnia (CBT-I); Focus of Attention (FOA); Combined CBT-I and FOA; and Sleep Hygiene (control group) for the treatment of insomnia. This study is a randomized, open label study, and the participants are asked to assess the benefits they get from the intervention. This study involve 6 weekly in person one-to-one sessions after screening and completion of the 1-week, 3-month, 6-month and 12-month follow-up assessment. The trained study staff will administering the treatment. The Research Department will administer the outcome measures. The review of insomnia improvement will be assessed at at end of treatment, 3 months, 6 months and 12 months follow-up.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Behavioral Treatment of Insomnia in Active-Duty Service Members With Traumatic Brain Injury

NCT06867666

Insomnia TBI (Traumatic Brain Injury)

RECRUITING NA

Low-intensity Cognitive-behavioural Therapy for Insomnia

NCT03736694

Insomnia

COMPLETED NA

Internet-based Treatment for Insomnia

NCT02261272

Psychophysiologic Insomnia

COMPLETED NA

Efficacy of a Computerized Cognitive Behavioral Treatment for Insomnia: Increasing Access to Insomnia Treatment to Decrease Suicide Risk

NCT03366870

Insomnia Physical Health Functioning Mental Health Functioning

COMPLETED NA

Overcoming Insomnia: Impact on Sleep, Health and Work of Online CBT-I

NCT02558647

Insomnia

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study compares the efficacy of four different types (Cognitive Behavior Therapy for Insomnia (CBT-I), Focus of Attention (FOA), Combined CBT-I and FOA and Sleep Hygiene) of therapies approaches for the treatment of insomnia. This study is a randomized, open label study, the participants are asked to review the benefits they get from the intervention. This study involve 6 weekly sessions after screening and completion of the end of treatment, 3-month, 6-month and 12-month follow-up assessment. The trained study staff will administer study scales during therapy session. The subjective review of insomnia improvement will be assessed at end of treatment, 3 months, 6 months and 12 months follow-up assessment. Subjects are adult who meet, DSM-5 the diagnostic criteria for primary Insomnia.

Inclusion/Exclusion criteria to be assessed at Screening (Visit 1) and Visit 2. For those found eligible who complete the study, participation will include Screening (Visit 1), 6 weekly sessions after screening, and completion of the post-treatment and 6-month followup assessment.

Once subject sign the consent form, subject will be asked inclusion and exclusion criteria and will be given details about the study as per protocol.

Those eligible will be randomly assigned to one of four behavioral treatment approaches. The participant will have six weekly one hour in person sessions in which the assigned treatment will be administered. The participant will be assessed at the end of treatment and again at 6 month followup.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Insomnia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel group

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cognitive Behavior Therapy-Insomnia

Participants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider.

Group Type ACTIVE_COMPARATOR