Depression, Insomnia, Primary
Conditions
Keywords
insomnia, depression, digital CBTI, online CBTI
Brief summary
The primary objective of the proposed research is to determine the efficacy of Digital Cognitive Behavior Therapy (dCBTI) in reducing severity of depression and also in preventing the incidence and relapse of depression among insomniacs. In addition, we will identify salient sociological/environmental variables, such as age, sex, education, socioeconomic status (SES), racial/ethnic minority-status, work schedule, child-care responsibilities (i.e., having children under the age of 3), stigma, that moderate the effects of this intervention.
Detailed description
The purpose of this study is to determine the effectiveness of Digital Cognitive Behavior Therapy for Insomnia (dCBTI) in reducing severity of depression and also in preventing the incidence and relapse of depression among insomniacs. dCBTI is an online form of Cognitive Behavioral Therapy (CBT) used with people who experience trouble sleeping at night (insomniacs). This study will allow us to determine whether this form of digital therapy is helpful in reducing the severity of depression and in preventing the development and relapse of depression in people suffering from insomnia. Participants will be recruited from several well-developed sources, including the HFHS Sleep Center Clinical database. Once a participant meets inclusion criteria and provides consent, a link to the internet portal will be provided to complete the remaining survey questions. After completion of this assessment, participants will be automatically randomized to one of 2 active online insomnia treatment conditions. Each treatment involves 6 weekly sessions which each take up to 20 minutes to complete. A post-treatment questionnaire immediately following the 6-week treatment phase will be completed. In addition, a follow up questionnaire assessment will be completed approximately 1 year after treatment. Each of the 3 separate questionnaires will take 20-30 minutes to complete. Participants will be compensated.
Interventions
BEHAVIORALdCBTI
BEHAVIORALSleep Education
Sponsors
Robert Wood Johnson Foundation
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meets Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition(DSMV) criteria for insomnia
Exclusion criteria
* Lack of insomnia, untreated sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome), bipolar disorder, history of seizure disorder, high depression chronicity (self-reported daily or near daily depressed mood and anhedonia)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Pre-Treatment | Pre-treatment (Day 1) | Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity) and incidence of depression |
| Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Post-Treatment | Post-treatment (~6 week after Screening) | Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity) |
| Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS), 1-year Follow-up | 1-year follow-up (58 week after screening) | Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity) |
| Severity of Symptoms of Insomnia [Time Frame: Pre-treatment (Day 1)] | Pre-treatment (Day 1) | Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Symptoms of Insomnia - Post Treatment | Post-treatment (~6 week after Screening) | Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity) |
| Severity of Symptoms of Insomnia - 1 Year Post Treatment | 1-year follow-up (58 week after screening) | Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| dCBTI Online access to the digital CBTI program Sleepio
dCBTI | 946 |
| Sleep Education Weekly email messages with sleep hygiene recommendations
Sleep Education | 439 |
| Total | 1,385 |
Baseline characteristics
| Characteristic | dCBTI | Sleep Education | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 93 Participants | 63 Participants | 156 Participants |
| Age, Categorical Between 18 and 65 years | 853 Participants | 376 Participants | 1229 Participants |
| Age, Continuous | 44.5 years STANDARD_DEVIATION 15.8 | 45.7 years STANDARD_DEVIATION 15.1 | 45 years STANDARD_DEVIATION 1.59 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 8 Participants | 24 Participants |
| Race (NIH/OMB) Black or African American | 171 Participants | 109 Participants | 280 Participants |
| Race (NIH/OMB) More than one race | 15 Participants | 9 Participants | 24 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 31 Participants | 16 Participants | 47 Participants |
| Race (NIH/OMB) White | 710 Participants | 294 Participants | 1004 Participants |
| Sex: Female, Male Female | 737 Participants | 351 Participants | 1088 Participants |
| Sex: Female, Male Male | 209 Participants | 88 Participants | 297 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 946 | 0 / 439 |
| other Total, other adverse events | 0 / 946 | 0 / 439 |
| serious Total, serious adverse events | 0 / 946 | 0 / 439 |
Outcome results
Primary
Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS), 1-year Follow-up
Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity)
Time frame: 1-year follow-up (58 week after screening)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| dCBTI | Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS), 1-year Follow-up | 4.7 score on a scale | Standard Deviation 4.3 |
| Sleep Education | Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS), 1-year Follow-up | 6.5 score on a scale | Standard Deviation 4.3 |
Primary
Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Post-Treatment
Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity)
Time frame: Post-treatment (~6 week after Screening)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| dCBTI | Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Post-Treatment | 3.9 score on a scale | Standard Deviation 4 |
| Sleep Education | Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Post-Treatment | 6.4 score on a scale | Standard Deviation 4.2 |
Primary
Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Pre-Treatment
Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity) and incidence of depression
Time frame: Pre-treatment (Day 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| dCBTI | Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Pre-Treatment | 10.8 score on a scale | Standard Deviation 4.5 |
| Sleep Education | Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Pre-Treatment | 10.8 score on a scale | Standard Deviation 4.6 |
Primary
Severity of Symptoms of Insomnia [Time Frame: Pre-treatment (Day 1)]
Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)
Time frame: Pre-treatment (Day 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| dCBTI | Severity of Symptoms of Insomnia [Time Frame: Pre-treatment (Day 1)] | 17.8 score on a scale | Standard Deviation 4.2 |
| Sleep Education | Severity of Symptoms of Insomnia [Time Frame: Pre-treatment (Day 1)] | 17.7 score on a scale | Standard Deviation 4.3 |
Secondary
Severity of Symptoms of Insomnia - 1 Year Post Treatment
Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)
Time frame: 1-year follow-up (58 week after screening)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| dCBTI | Severity of Symptoms of Insomnia - 1 Year Post Treatment | 8.2 score on a scale | Standard Deviation 6.2 |
| Sleep Education | Severity of Symptoms of Insomnia - 1 Year Post Treatment | 12.8 score on a scale | Standard Deviation 5.6 |
Secondary
Severity of Symptoms of Insomnia - Post Treatment
Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)
Time frame: Post-treatment (~6 week after Screening)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| dCBTI | Severity of Symptoms of Insomnia - Post Treatment | 17.9 score on a scale | Standard Deviation 4.3 |
| Sleep Education | Severity of Symptoms of Insomnia - Post Treatment | 17.7 score on a scale | Standard Deviation 4.4 |