Depression
Conditions
Keywords
Depression, Behavioral Activation, Tele-medicine
Brief summary
This study will evaluate the effectiveness of a web-based behavioral activation(BA) treatment for depression by comparing it to in-person BA treatment in Soldiers and Veterans with Major and Minor Depressive Disorder. We will test the hypothesis that 8 sessions of in-home BA delivered via a webcam will be as safe and effective in reducing symptoms of hopelessness and depression as in-person BA treatment for depression.
Interventions
BEHAVIORALBehavioral Activation
Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
Sponsors
VA Office of Research and Development
National Center for Telehealth and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Current Major Depressive or Minor Depressive Disorder * High-speed internet/network access at home (384kbs minimum) * Informed consent * Fluent in the English language
Exclusion criteria
* Currently undergoing psychotherapy for depression * less than 18 or greater than 65 year of age * Active psychotic symptoms/disorders as determined by the SCID for DSM-IV * Dysthymic Disorder * Current suicidal ideation with intent or recent (within six months) history of a suicide attempt * History of Organic Mental Disorder * Current substance dependence as determined by the SCID (lifetime substance dependence or substance abuse will not be excluded) * History of violence or poor impulse control causing potential risk to staff or others * Significant ongoing stressors that require urgent crisis intervention * Having a living arrangement that will not permit the use of a private space to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beck Hopelessness Scale (BHS) | Post treatment - Week 8 | The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Treatment Session Week 1 | Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist. |
| Beck Depression Inventory -II (BDI-II) | Baseline | The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome. |
| Beck Hopelessness Scale (BHS) | Baseline | The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| In Home Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies. | 62 |
| In-Person Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies. | 59 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 5 |
| Overall Study | randomized did not start treatment | 3 | 3 |
| Overall Study | Withdrawal by Subject | 16 | 9 |
Baseline characteristics
| Characteristic | Total | In Home | In-Person |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 121 Participants | 62 Participants | 59 Participants |
| Age, Continuous | 35.1 years STANDARD_DEVIATION 12.1 | 34.8 years STANDARD_DEVIATION 12.4 | 35.6 years STANDARD_DEVIATION 11.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 3 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 108 Participants | 56 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 8 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 6 Participants | 7 Participants |
| Race (NIH/OMB) White | 85 Participants | 44 Participants | 41 Participants |
| Region of Enrollment United States | 121 participants | 62 participants | 59 participants |
| Sex: Female, Male Female | 22 Participants | 10 Participants | 12 Participants |
| Sex: Female, Male Male | 99 Participants | 52 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 62 | 1 / 59 |
| serious Total, serious adverse events | 3 / 62 | 1 / 59 |
Outcome results
Primary
Beck Hopelessness Scale (BHS)
The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.
Time frame: Post treatment - Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In Home | Beck Hopelessness Scale (BHS) | 4.888889 units on a scale | Standard Deviation 4.642796 |
| In-Person | Beck Hopelessness Scale (BHS) | 4.428571 units on a scale | Standard Deviation 4.939353 |
90% CI: [0.12, 0.68]
Secondary
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time frame: Treatment Session Week 7
Population: adverse events are reported in adverse event section
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In Home | Adverse Events | 0 participants |
| In-Person | Adverse Events | 0 participants |
Secondary
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time frame: Treatment Session Week 1
Population: AE data reported in adverse events section
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In Home | Adverse Events | 0 participants |
| In-Person | Adverse Events | 0 participants |
Secondary
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time frame: 3 month follow up
Population: Adverse event data is recorded in adverse event section
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In Home | Adverse Events | 6 participants |
| In-Person | Adverse Events | 2 participants |
Secondary
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time frame: Treatment Session Week 2
Population: adverse event data reported in adverse event section
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In Home | Adverse Events | 0 participants |
| In-Person | Adverse Events | 0 participants |
Secondary
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time frame: Treatment Session Week 3
Population: adverse event data reported in adverse event section
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In Home | Adverse Events | 62 participants |
| In-Person | Adverse Events | 59 participants |
Secondary
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time frame: Treatment Session Week 4
Population: Adverse Event data recorded in Adverse event section
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In Home | Adverse Events | 0 participants |
| In-Person | Adverse Events | 0 participants |
Secondary
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time frame: Treatment Session Week 5
Population: adverse events are reported in adverse event section
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In Home | Adverse Events | 0 participants |
| In-Person | Adverse Events | 0 participants |
Secondary
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time frame: Treatment Session Week 6
Population: adverse events are reported in the adverse event section
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In Home | Adverse Events | 0 participants |
| In-Person | Adverse Events | 0 participants |
Secondary
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time frame: Treatment Session Week 8
Population: Adverse event data recorded in adverse event section
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In Home | Adverse Events | 0 participants |
| In-Person | Adverse Events | 0 participants |
Secondary
Beck Depression Inventory -II (BDI-II)
The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.
Time frame: 3 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In Home | Beck Depression Inventory -II (BDI-II) | 14.7619 units on a scale | Standard Deviation 12.88752 |
| In-Person | Beck Depression Inventory -II (BDI-II) | 15 units on a scale | Standard Deviation 12.61065 |
Secondary
Beck Depression Inventory -II (BDI-II)
The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In Home | Beck Depression Inventory -II (BDI-II) | 27.59678 units on a scale | Standard Deviation 10.44652 |
| In-Person | Beck Depression Inventory -II (BDI-II) | 29.71186 units on a scale | Standard Deviation 11.33054 |
Secondary
Beck Depression Inventory -II (BDI-II)
The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome
Time frame: Midpoint- Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In Home | Beck Depression Inventory -II (BDI-II) | 19.40425 units on a scale | Standard Deviation 11.77444 |
| In-Person | Beck Depression Inventory -II (BDI-II) | 20.20455 units on a scale | Standard Deviation 13.09106 |
Secondary
Beck Depression Inventory -II (BDI-II)
The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.
Time frame: Post Treatment- Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In Home | Beck Depression Inventory -II (BDI-II) | 13.82222 units on a scale | Standard Deviation 12.01947 |
| In-Person | Beck Depression Inventory -II (BDI-II) | 11.7381 units on a scale | Standard Deviation 12.07509 |
90% CI: [0.16, 0.78]
Secondary
Beck Hopelessness Scale (BHS)
The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.
Time frame: Midpoint- Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In Home | Beck Hopelessness Scale (BHS) | 7.041667 units on a scale | Standard Deviation 5.63786 |
| In-Person | Beck Hopelessness Scale (BHS) | 7.954545 units on a scale | Standard Deviation 6.261564 |
Secondary
Beck Hopelessness Scale (BHS)
The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In Home | Beck Hopelessness Scale (BHS) | 9 units on a scale | Standard Deviation 5.118273 |
| In-Person | Beck Hopelessness Scale (BHS) | 10.37288 units on a scale | Standard Deviation 6.133285 |
Secondary
Beck Hopelessness Scale (BHS)
The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.
Time frame: 3 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In Home | Beck Hopelessness Scale (BHS) | 5.214286 units on a scale | Standard Deviation 5.101582 |
| In-Person | Beck Hopelessness Scale (BHS) | 5.527778 units on a scale | Standard Deviation 5.973686 |