Depressive Symptoms
Conditions
Brief summary
This study aims to test the effectiveness of a computer-assisted cognitive behavioral therapy for depression among rural adults. The intervention, called Raising Our Spirits Together (ROST), was developed via a community-based participatory approach and will be delivered in small groups, facilitated by local pastors. Groups will be held virtually, or in-person at two churches in rural Michigan. Eighty-four individuals will be recruited from Hillsdale, Michigan, to test the effect of ROST on depressive symptoms, compared to an Enhanced Control Condition (ECC).
Interventions
BEHAVIORALRaising Our Spirits Together
Raising Our Spirits Together (ROST) is an 8-session computer-assisted cognitive behavioral therapy for depression. Core CBT content, including behavioral activation, cognitive restructuring, and problem solving, are delivered via the computer-assisted platform using video and text-based elements. The computer-assisted intervention is complemented by a workbook that includes in-session exercises as well as homework/action plans. ROST is delivered weekly, either virtually or in-person at a local church, and facilitated by a local pastor.
OTHEREnhanced Control Condition
The Enhanced Control Condition intervention consists of providing participants randomized to this condition with a self-help book for depression (The Depression Helpbook; Katon et al, 2008) that is widely used and found to be beneficial, a local resource guide, and referrals.
Sponsors
University of Michigan
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must live in Hillsdale, Lenawee, Jackson, or Calhoun County, Michigan * Positive screen for at least mild depressive symptoms based on the the Patient Health Questionnaire-9 (PHQ-9\>=5)
Exclusion criteria
* Non-English speaking * Currently receiving cognitive behavioral therapy (CBT) for depression * Ever completed a course of cognitive behavioral therapy (CBT; \>=8 sessions) * Diagnosis of a psychotic disorder * Current use of opiates or freebase cocaine * Prominent suicidal/homicidal ideation with imminent risk.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-report Measure of Depressive Symptoms | Outcome will be assessed at baseline, immediately post-treatment (up to 8 weeks), and 12-weeks post-treatment | Participants will self report depressive symptoms utilizing the Patient Health Questionnaire-9 (PHQ-9; range 0-27 with higher scores indicating worse outcome) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAddie Weaver, PhD
University of Michigan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Raising Our Spirits Together Intervention Raising Our Spirits Together (ROST) is an 8-session computer-assisted cognitive behavioral therapy for depression. Core CBT content, including behavioral activation, cognitive restructuring, and problem solving, are delivered via the computer-assisted platform using video and text-based elements. The computer-assisted intervention is complemented by a workbook that includes in-session exercises as well as homework/action plans. ROST is delivered weekly, either virtually or in-person at a local church, and facilitated by a local pastor. | 40 |
| Enhanced Control Condition The Enhanced Control Condition intervention consists of providing participants randomized to this condition with a self-help book for depression (The Depression Helpbook; Katon et al, 2008) that is widely used and found to be beneficial, a local resource guide, and referrals. | 30 |
| Total | 70 |
Baseline characteristics
| Characteristic | Raising Our Spirits Together Intervention | Total | Enhanced Control Condition |
|---|---|---|---|
| Age, Continuous | 45.63 years STANDARD_DEVIATION 15.26 | 43.03 years STANDARD_DEVIATION 14.81 | 39.57 years STANDARD_DEVIATION 13.68 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 66 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 35 Participants | 60 Participants | 25 Participants |
| Region of Enrollment United States | 40 participants | 70 participants | 30 participants |
| Sex: Female, Male Female | 31 Participants | 61 Participants | 30 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 30 |
| other Total, other adverse events | 1 / 40 | 0 / 30 |
| serious Total, serious adverse events | 0 / 40 | 0 / 30 |
Outcome results
Primary
Change in Self-report Measure of Depressive Symptoms
Participants will self report depressive symptoms utilizing the Patient Health Questionnaire-9 (PHQ-9; range 0-27 with higher scores indicating worse outcome)
Time frame: Outcome will be assessed at baseline, immediately post-treatment (up to 8 weeks), and 12-weeks post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Raising Our Spirits Together Intervention | Change in Self-report Measure of Depressive Symptoms | PHQ-9 Baseline | 13.90 score on PHQ-9 | Standard Deviation 5.49 |
| Raising Our Spirits Together Intervention | Change in Self-report Measure of Depressive Symptoms | PHQ-9 Post-treatment | 7.00 score on PHQ-9 | Standard Deviation 5.67 |
| Raising Our Spirits Together Intervention | Change in Self-report Measure of Depressive Symptoms | PHQ-9 Follow-up | 7.72 score on PHQ-9 | Standard Deviation 7.36 |
| Enhanced Control Condition | Change in Self-report Measure of Depressive Symptoms | PHQ-9 Baseline | 13.43 score on PHQ-9 | Standard Deviation 4.4 |
| Enhanced Control Condition | Change in Self-report Measure of Depressive Symptoms | PHQ-9 Post-treatment | 7.57 score on PHQ-9 | Standard Deviation 4.03 |
| Enhanced Control Condition | Change in Self-report Measure of Depressive Symptoms | PHQ-9 Follow-up | 8.10 score on PHQ-9 | Standard Deviation 5.51 |