Depression in Old Age
Conditions
Keywords
depression, geriatric, psychotherapy, group
Brief summary
The purpose of this study is to test the feasibility of one type of therapy session, Virtual Augmented Engage (Engage-A). The research is being done because the researchers are trying to learn if these approaches could be used by therapists in the community social service agencies to treat older adults with depression. The research will also measure clinician satisfaction after training and supervision of utilization of Engage-A.
Interventions
BEHAVIORALEngage-A
Therapist will encourage participants to engage in physical and social activities that are pleasurable or rewarding. Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression.
OTHERTraining and utilizing Engage-A therapy
Therapist will be trained in Engage-A therapy and given supervision while utilizing this therapy.
Sponsors
National Institute of Mental Health (NIMH)
Weill Medical College of Cornell University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 55 years' old * PHQ-9 Score of ≥ 10 * English or Spanish speaking * MOCA ≥ 24 or mini-telephone MOCA ≥ 11 * Member of/attends one of the REDS Senior Centers * Capacity to provide written consent for both research assessment and the Engage-A intervention.
Exclusion criteria
* Current active suicidal ideation defined by MADRS Suicide Item ≥ 4 (probably better off dead. Suicidal thoughts are common, and suicide is considered as a possible solution, but without specific plans or intention). * Presence of psychiatric diagnoses other than unipolar, non-psychotic major depression or generalized anxiety disorder by SCID-IV. * Severe or life-threatening medical illness (e.g., end stage organ failure). * Currently seeing an individual psychotherapist \*(if individuals are willing to go on a hiatus from their individual psychotherapist for the 15 weeks of the study, and meet all inclusion criteria, they will be considered eligible).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Virtual ENGAGE-A Participants Who Attend Every Scheduled Therapy Session | 9 Weeks | Number of Virtual ENGAGE-A Participants who Attend Every Scheduled Therapy Session |
| Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ | 6 weeks, 9 weeks, 12 weeks | The Client Satisfaction Questionnaire (CSQ) assesses the clients' satisfaction with the services they are receiving. The CSQ ranges from 1-4, with higher scores indicating higher satisfaction. Domain 1 scores range from 1-4, with higher scores indicating higher satisfaction with the program. Domain 2 scores range from 1-4, with higher scores indicating higher satisfaction with the services received. Domain 3 scores range from 1-4, with higher scores indicating higher likelihood of wanting to receive similar services in the future. Higher scores for all three domains indicate a better outcome. |
| Average Satisfaction Score of Community Clinicians (LCSW) as Measured by the TSQ | 2 years | The Therapist Satisfaction Questionnaire (TSQ) assesses the therapists' satisfaction with the Alacrity therapy training and intervention. The TSQ ranges from 1-4, with higher scores indicating higher satisfaction. Domain 1 scores range from 1-4, with higher scores indicating higher satisfaction with the skills obtained through training. Domain 2 scores range from 1-4, with higher scores indicating higher satisfaction with the therapy type. Domain 3 scores range from 1-4, with higher scores indicating higher likelihood that the therapist would use this therapy in their own practice. Higher scores for all three domains indicate better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depressive Symptoms of Virtual ENGAGE-A Participants as Measured by HAM-D | Baseline, 6 week, 9 week, 12 week | Hamilton Depression Rating Score (HAM-D) assesses the severity of depression in patients. The HAM-D ranges from 0 to 52, with higher scores indicating higher severity of depression. |
| Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS | Baseline, 6 week, 9 week, 12 week | The Behavioral Activation for Depression Scale (BADS) measures levels of behavioral activation. The BADS ranges from 0 to 150, with higher scores indicating lower levels of behavioral activation. Domain 1 scores range from 0-42. Higher scores (better outcome) indicate greater activation. Domain 2 scores range from 0-48. Higher scores (worse outcome) indicate greater Avoidance and Rumination. Domain 3 scores range from 0-30. Higher scores (worse outcome) indicate greater Work/School impairment. Domain 4 scores range from 0-30. Higher scores (worse outcome) indicate greater social impairment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Engage-A Participants receive 9 individual in-person or remote therapy sessions. Each session will last approximately 60 minutes. During the sessions, the therapist will encourage the participant to engage in physical and social activities that are pleasurable or rewarding.
Engage-A: Therapist will encourage participants to engage in physical and social activities that are pleasurable or rewarding. Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression. | 22 |
| Clinician Participants Clinicians who provided the ENGAGE intervention and participated in data collection about their experience. | 4 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Engage-A | Clinician Participants |
|---|---|---|---|
| Age, Continuous | 66.68 years STANDARD_DEVIATION 6.53 | 66.68 years STANDARD_DEVIATION 6.53 | 48.5 years STANDARD_DEVIATION 10.43 |
| Behavioral Activation for Depression Scale (BADS) Domain 1, Baseline | 18.62 units on a scale STANDARD_DEVIATION 10.22 | 18.62 units on a scale STANDARD_DEVIATION 10.22 | — |
| Behavioral Activation for Depression Scale (BADS) Domain 2, Baseline | 22.50 units on a scale STANDARD_DEVIATION 8.61 | 22.50 units on a scale STANDARD_DEVIATION 8.61 | — |
| Behavioral Activation for Depression Scale (BADS) Domain 3, Baseline | 13.76 units on a scale STANDARD_DEVIATION 6.77 | 13.76 units on a scale STANDARD_DEVIATION 6.77 | — |
| Behavioral Activation for Depression Scale (BADS) Domain 4, Baseline | 20.25 units on a scale STANDARD_DEVIATION 6.91 | 20.25 units on a scale STANDARD_DEVIATION 6.91 | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 19 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hamilton Psychiatric Rating Scale for Depression (HAM-D) | 21.28 units on a scale STANDARD_DEVIATION 5.6 | 21.28 units on a scale STANDARD_DEVIATION 5.6 | — |
| 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 | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 18 Participants | 4 Participants |
| Region of Enrollment United States | 26 participants | 22 participants | 4 participants |
| Sex: Female, Male Female | 24 Participants | 20 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 0 |
| other Total, other adverse events | 0 / 22 | 0 / 0 |
| serious Total, serious adverse events | 0 / 22 | 0 / 0 |
Outcome results
Primary
Average Satisfaction Score of Community Clinicians (LCSW) as Measured by the TSQ
The Therapist Satisfaction Questionnaire (TSQ) assesses the therapists' satisfaction with the Alacrity therapy training and intervention. The TSQ ranges from 1-4, with higher scores indicating higher satisfaction. Domain 1 scores range from 1-4, with higher scores indicating higher satisfaction with the skills obtained through training. Domain 2 scores range from 1-4, with higher scores indicating higher satisfaction with the therapy type. Domain 3 scores range from 1-4, with higher scores indicating higher likelihood that the therapist would use this therapy in their own practice. Higher scores for all three domains indicate better outcomes.
Time frame: 2 years
Population: Engage-A participants were not analyzed as part of this measure as it does not apply to them.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinician Participants | Average Satisfaction Score of Community Clinicians (LCSW) as Measured by the TSQ | Domain 1 | 4.0 units on a scale | Standard Deviation 0 |
| Clinician Participants | Average Satisfaction Score of Community Clinicians (LCSW) as Measured by the TSQ | Domain 2 | 4.0 units on a scale | Standard Deviation 0 |
| Clinician Participants | Average Satisfaction Score of Community Clinicians (LCSW) as Measured by the TSQ | Domain 3 | 4.0 units on a scale | Standard Deviation 0 |
Primary
Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ
The Client Satisfaction Questionnaire (CSQ) assesses the clients' satisfaction with the services they are receiving. The CSQ ranges from 1-4, with higher scores indicating higher satisfaction. Domain 1 scores range from 1-4, with higher scores indicating higher satisfaction with the program. Domain 2 scores range from 1-4, with higher scores indicating higher satisfaction with the services received. Domain 3 scores range from 1-4, with higher scores indicating higher likelihood of wanting to receive similar services in the future. Higher scores for all three domains indicate a better outcome.
Time frame: 6 weeks, 9 weeks, 12 weeks
Population: The number of participants analyzed at week 6 was 18, at week 9 was 16, and at week 12 was 15 due to loss to follow up and participant withdrawal.~Clinician Participants were not analyzed for this measure as it does not apply to them.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engage-A | Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ | Domain 2- week 6 | 2.89 units on a scale | Standard Deviation 0.76 |
| Engage-A | Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ | Domain 2- week 9 | 3.31 units on a scale | Standard Deviation 0.79 |
| Engage-A | Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ | Domain 1- week 6 | 2.5 units on a scale | Standard Deviation 0.62 |
| Engage-A | Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ | Domain 3- week 6 | 2.83 units on a scale | Standard Deviation 0.79 |
| Engage-A | Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ | Domain 1- week 9 | 2.5 units on a scale | Standard Deviation 0.63 |
| Engage-A | Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ | Domain 3- week 9 | 3.33 units on a scale | Standard Deviation 0.9 |
| Engage-A | Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ | Domain 1- week 12 | 2.73 units on a scale | Standard Deviation 0.88 |
| Engage-A | Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ | Domain 2- week 12 | 3.40 units on a scale | Standard Deviation 0.74 |
| Engage-A | Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ | Domain 3- week 12 | 3.27 units on a scale | Standard Deviation 0.88 |
Primary
Number of Virtual ENGAGE-A Participants Who Attend Every Scheduled Therapy Session
Number of Virtual ENGAGE-A Participants who Attend Every Scheduled Therapy Session
Time frame: 9 Weeks
Population: The total number of participants that completed all scheduled therapy sessions at week 9. The number of participants analyzed at week 9 for this measure (17) is higher than the number analyzed for the other measures at week 9 (16) because one participant attended the week 9 therapy session but left the study before having completed the week 9 assessment, during which the remaining measures are completed.~Clinician Participants were not analyzed for this measure as it does not apply to them.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Engage-A | Number of Virtual ENGAGE-A Participants Who Attend Every Scheduled Therapy Session | 17 Participants |
Secondary
Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS
The Behavioral Activation for Depression Scale (BADS) measures levels of behavioral activation. The BADS ranges from 0 to 150, with higher scores indicating lower levels of behavioral activation. Domain 1 scores range from 0-42. Higher scores (better outcome) indicate greater activation. Domain 2 scores range from 0-48. Higher scores (worse outcome) indicate greater Avoidance and Rumination. Domain 3 scores range from 0-30. Higher scores (worse outcome) indicate greater Work/School impairment. Domain 4 scores range from 0-30. Higher scores (worse outcome) indicate greater social impairment.
Time frame: Baseline, 6 week, 9 week, 12 week
Population: The number of participants analyzed was 21 at baseline, 18 at week 6, 16 at week 9, and 15 at week 12.~Clinician Participants were not analyzed for this measure as it does not apply to them.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engage-A | Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS | Domain 1, Baseline | 18.62 units on a scale | Standard Deviation 10.22 |
| Engage-A | Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS | Domain 2, Baseline | 22.50 units on a scale | Standard Deviation 8.61 |
| Engage-A | Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS | Domain 3, Baseline | 13.76 units on a scale | Standard Deviation 6.77 |
| Engage-A | Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS | Domain 4, Baseline | 20.25 units on a scale | Standard Deviation 6.91 |
| Engage-A | Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS | Domain 1, Week 6 | 24.67 units on a scale | Standard Deviation 7.58 |
| Engage-A | Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS | Domain 2, Week 6 | 27.94 units on a scale | Standard Deviation 8.77 |
| Engage-A | Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS | Domain 3, Week 6 | 16.61 units on a scale | Standard Deviation 7.16 |
| Engage-A | Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS | Domain 4, Week 6 | 22.0 units on a scale | Standard Deviation 7.23 |
| Engage-A | Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS | Domain 1, Week 9 | 27.94 units on a scale | Standard Deviation 7.03 |
| Engage-A | Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS | Domain 2, Week 9 | 30.19 units on a scale | Standard Deviation 11.23 |
| Engage-A | Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS | Domain 3, Week 9 | 20.19 units on a scale | Standard Deviation 5.55 |
| Engage-A | Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS | Domain 4, Week 9 | 23.88 units on a scale | Standard Deviation 5.89 |
| Engage-A | Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS | Domain 1, Week 12 | 24.40 units on a scale | Standard Deviation 10.22 |
| Engage-A | Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS | Domain 2, Week 12 | 31.33 units on a scale | Standard Deviation 12.83 |
| Engage-A | Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS | Domain 3, Week 12 | 21.47 units on a scale | Standard Deviation 7.61 |
| Engage-A | Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS | Domain 4, Week 12 | 23.93 units on a scale | Standard Deviation 8.24 |
Secondary
Change in Depressive Symptoms of Virtual ENGAGE-A Participants as Measured by HAM-D
Hamilton Depression Rating Score (HAM-D) assesses the severity of depression in patients. The HAM-D ranges from 0 to 52, with higher scores indicating higher severity of depression.
Time frame: Baseline, 6 week, 9 week, 12 week
Population: The total number of participants analyzed was 18 at baseline, 18 at week 6, 16 at week 9, and 15 and week 12 due to participant withdrawal and loss to follow-up.~Clinician Participants were not analyzed for this measure as it does not apply to them.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engage-A | Change in Depressive Symptoms of Virtual ENGAGE-A Participants as Measured by HAM-D | Week 12 | 11.67 units on a scale | Standard Deviation 6.72 |
| Engage-A | Change in Depressive Symptoms of Virtual ENGAGE-A Participants as Measured by HAM-D | Baseline | 21.24 units on a scale | Standard Deviation 5.77 |
| Engage-A | Change in Depressive Symptoms of Virtual ENGAGE-A Participants as Measured by HAM-D | Week 6 | 14.47 units on a scale | Standard Deviation 5.49 |
| Engage-A | Change in Depressive Symptoms of Virtual ENGAGE-A Participants as Measured by HAM-D | Week 9 | 11.19 units on a scale | Standard Deviation 5.65 |