Depression
Conditions
Keywords
Depression, Telephone Cognitive Behavior Therapy, Internet Cognitive Behavioral Therapy
Brief summary
This is a randomized, controlled trial comparing telephone-cognitive behavior therapy (T-CBT) with a therapist to a Stepped Care intervention for depression treatment (iCBT with support from a telephone coach with the possibility of being stepped up to receiving T-CBT with a therapist).
Detailed description
Major depressive disorder (MDD) is common, with 12-month prevalence rates estimated to be between 6.6-10.3%. While many depressed patients state they would prefer psychological treatment to pharmacotherapy, substantial barriers to care exist, including cost, practical barriers such as time constraints and transportation, emotional barriers such as stigma, decreased motivation associated with depression itself, physical disability, and lack of availability of services. Telemental health has been proposed as a method of overcoming barriers to treatment. Research has focused primarily on two formats: the telephone and the Internet. Use of the telephone as a delivery medium produces reductions in depression equivalent to face-to-face psychological treatments, while also significantly reducing attrition. However, its success in outreach can also significantly increase costs for healthcare providing organizations. Internet interventions have the potential to produce moderate gains when supported by therapist or coach via brief telephone calls or e-mail but are also less expensive than standard therapy. Developing healthcare models that integrate treatment delivery media holds the promise of harnessing the advantages of each media, while minimizing the disadvantages. Stepped care models are a potentially useful framework for achieving such an integration. The stepped care model we will test initiates treatment with a validated, guided Internet cognitive behavioral therapy program. If patients fail to respond, they will be stepped up to a validated telephone-cognitive behavior therapy (T-CBT). The stepped care model will be compared to T-CBT in a randomized trial. Patients will be recruited from primary care and treated for up to 20 weeks, or until sustained remission is achieved.
Interventions
BEHAVIORALStepped Care
Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist
BEHAVIORALTelephone Cognitive Behavior Therapy
Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).
Sponsors
Northwestern University
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
* Has a DSM-IV diagnosis of non-psychotic major depressive disorder (MDD) as assessed using the Mini International Neuropsychiatric Interview (MINI), plus a score of 12 or greater on the Quick Inventory of Depressive Symptomatology - Clinician Rated (QIDS-C) * Has a phone, access to the Internet, and basic internet skills * Is at least 18 years of age * Is able to speak and read English * If currently taking an antidepressant medication, participant must have been on a stable dose for at least two weeks, and have no plans to change the dose
Exclusion criteria
* Has visual, hearing, voice, or motor impairment that would prevent completion of study procedures * Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, substance use or other diagnosis for which participation in this trial is either inappropriate or dangerous * Is severely suicidal (has ideation, plan, and intent) * Is currently receiving or planning to begin psychotherapy during the study treatment period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression | Baseline, midtreatment, end of treatment, 3 month post treatment, and 6 month post-treatment follow-up | To measure changes in the Quick Inventory of Depressive Symptomatology (QIDS) over time. The QIDS is made up of 16 items and has a possible range of scores of 0 to 27. Higher scores represent worse outcomes. |
| Cost-Effectiveness | Baseline to end of treatment | Measure the ratio of the difference in costs and difference in effectiveness between the two groups, Stepped care minus Telephone Cognitive Behavior Therapy. Below are reported individual cost means and standard deviations for therapist costs during study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stepped Care Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist
Stepped Care: Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist | 157 |
| Telephone Cognitive Behavior Therapy Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).
Telephone Cognitive Behavior Therapy: Participants will receive telephone-administered cognitive behavioral therapy (T-CBT). | 155 |
| Total | 312 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 17 | 16 |
Baseline characteristics
| Characteristic | Total | Telephone Cognitive Behavior Therapy | Stepped Care |
|---|---|---|---|
| Age, Continuous | 33 years | 32 years | 33 years |
| Baseline QIDS (Quick Inventory of Depressive Symptomatology) | 14 units on a scale | 14 units on a scale | 14 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants | 20 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 275 Participants | 134 Participants | 141 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 1 Participants | 4 Participants |
| PHQ-9 (Patient Health Questionnaire 9) | 16 units on a scale | 17 units on a scale | 16 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 12 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 265 Participants | 130 Participants | 135 Participants |
| Sex: Female, Male Female | 229 Participants | 111 Participants | 118 Participants |
| Sex: Female, Male Male | 81 Participants | 44 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 157 | 0 / 155 |
| other Total, other adverse events | 0 / 157 | 0 / 155 |
| serious Total, serious adverse events | 0 / 157 | 0 / 155 |
Outcome results
Primary
Cost-Effectiveness
Measure the ratio of the difference in costs and difference in effectiveness between the two groups, Stepped care minus Telephone Cognitive Behavior Therapy. Below are reported individual cost means and standard deviations for therapist costs during study.
Time frame: Baseline to end of treatment
Population: All randomized participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care | Cost-Effectiveness | 391.81 dollars | Standard Deviation 229.06 |
| Telephone Cognitive Behavior Therapy | Cost-Effectiveness | 756.14 dollars | Standard Deviation 298.64 |
Comparison: We calculated the ICER (Incremental cost-effectiveness ratio) estimate, computed using the difference in average cost between the two arms, divided by the difference in average Depression Free Days (DFD) as defined using QIDS (Quick Inventory of Depressive Symptomatology), between the two arms, Stepped Care minus Telephone Cognitive Behavior Therapy. The confidence interval was created using bootstrapping.95% CI: [-1143.09, 1094.72]
Primary
Depression
To measure changes in the Quick Inventory of Depressive Symptomatology (QIDS) over time. The QIDS is made up of 16 items and has a possible range of scores of 0 to 27. Higher scores represent worse outcomes.
Time frame: Baseline, midtreatment, end of treatment, 3 month post treatment, and 6 month post-treatment follow-up
Population: Participants with at least one followup visit which recorded the QIDS post baseline
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Stepped Care | Depression | Midtreatment | 10.51 units on a scale | Standard Error 0.4 |
| Stepped Care | Depression | End of Treatment | 7.84 units on a scale | Standard Error 0.38 |
| Stepped Care | Depression | Month 3 (post treatment) | 7.78 units on a scale | Standard Error 0.42 |
| Stepped Care | Depression | Month 6 (post treatment) | 7.89 units on a scale | Standard Error 0.44 |
| Telephone Cognitive Behavior Therapy | Depression | Month 6 (post treatment) | 8.24 units on a scale | Standard Error 0.42 |
| Telephone Cognitive Behavior Therapy | Depression | Midtreatment | 11.22 units on a scale | Standard Error 0.39 |
| Telephone Cognitive Behavior Therapy | Depression | Month 3 (post treatment) | 7.88 units on a scale | Standard Error 0.4 |
| Telephone Cognitive Behavior Therapy | Depression | End of Treatment | 7.71 units on a scale | Standard Error 0.37 |