Depression
Conditions
Keywords
Memory Deficits, Geriatric Depression, Cognitive Impairment, Executive Dysfunction, Disability, Problem Solving Therapy
Brief summary
This study will evaluate the efficacy of Problem Adaptation Therapy (PATH) vs. Supportive Therapy for Cognitively Impaired (ST-CI) older adults in reducing depression and disability in treating depressed, cognitively impaired older adults.
Detailed description
Depression, cognitive impairment, and disability often coexist in older adults and can lead to patient suffering and family disruption. Moreover, many depressed, cognitively impaired older adults have slow, poor, or unstable response to antidepressant drugs. Despite the need for treatments other than medication, most psychotherapy research focuses on either cognitively intact patients with limited disability or on dementia patients with pronounced disability. Thus, the available treatments do not fully address the needs of the large number of depressed elders with intermediate cognitive impairment and disability. Previous studies with cognitively impaired psychiatric populations have taught participants compensatory strategies to overcome their behavioral and cognitive limitations. This study will evaluate the efficacy of Problem Adaptation Therapy (PATH) a type of psychotherapy using a problem solving therapy (PST) approach, specially tailored compensatory strategies and environmental adaptations and caregiver involvement in treating depressed, cognitively impaired older adults. All participants in this single-blind study will undergo initial evaluations, including a 2-hour interview to assess depression, memory, and physical functioning; questions about medical history; and a neuropsychological exam. Participants will then be randomly assigned to one of two treatment groups: PATH or ST-CI. Participants assigned to PATH will receive 12 weekly sessions conducted at the home of the participants. During these sessions, a therapist will identify the participant's difficulties in life related to depression and physical functioning and will provide strategies to overcome these difficulties. The goal of treatment is to improve adaptive functioning in the home environment, which in turn may reduce depression and disability. The first session will last between 1 and 2 hours, and the remaining 11 sessions will last 1 hour. Participants assigned to ST-CI will also receive 12 weekly treatment sessions with a therapist conducted at the home of the participants. During supportive therapy sessions, the therapist will help participants to express feelings and to focus on their strengths and abilities when working through difficulties and transitions. For all participants, initial assessments will be repeated at Weeks 4, 8, 12, and 24.
Interventions
BEHAVIORALPATH
PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning.
BEHAVIORALST-CI
Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character.
Sponsors
National Institute of Mental Health (NIMH)
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meets Diagnostic and Statistical Manual for Mental Disorders(DSM)IV criteria for unipolar major depression * Severity of depression greater than or equal to 17 on MADRS * Disability as determined by at least 1 impairment in instrumental activities of daily living * Evidence of executive dysfunction or impairment in at least one of the following cognitive domains of Dementia Rating Scale (DRS): attention, construction, conceptualization, and memory (\[scaled score less than 7\] adjusted for age and race based on Mayo's older participants normative data) * Family member or caregiver able and willing to participate in treatment * Not currently taking antidepressants, cholinesterase inhibitors, or memantine or on a stable dosage for 8 weeks prior to study entry with no medical recommendation for change of these agents in the near future
Exclusion criteria
* High suicide risk * Axis I psychiatric disorder or substance abuse other than unipolar major depression or nonpsychotic depression * Axis II diagnosis of antisocial personality * Moderate to severe dementia: DRS total score corresponding to moderate or more severe impairment (scaled score less than or equal to 5) * Acute or severe medical illness (e.g., delirium; metastatic cancer; decompensated cardiac; liver or kidney failure; major surgery; stroke; myocardial infarction during the 3 months prior to entry) * Currently taking drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids) * Currently receiving psychotherapy * Aphasia * Sensory problems * Inability to speak English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery Asberg Depression Scale (MADRS) | 12 week outcome | Montgomery Asberg Depression Scale (MADRS) is a depression rating scale. Range of scores (1-35). Higher scores represent worse outcome (depression). |
| WHO Disability Assessment Schedule (WHODAS)-II | 12-week outcome | WHO Disability Assessment Schedule (WHODAS)-II is a disability scale. Range of scores: 12-43. Higher scores represent worse outcome (disability). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale | Outcome at 12 weeks | Hamilton Depression Rating Scale is a scale measuring depression severity. Range of scores: 1-33. Higher scores reflect worse outcome (depression). |
| Sheehan Disability Scale. | Outcome at 12 weeks | Sheehan Disability Scale is a measure of disability. Range of scores: 0-20. Higher scores reflect worse outcome (disability). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PATH Participants will receive PATH for 12 weeks
PATH: PATH aims to improve emotion regulation and reduce the negative impact of behavioral and functional limitations. The strategies of PATH are consistent with the process model of emotion regulation. PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning. | 37 |
| ST-CI Participants will receive ST-CI for 12 weeks
ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character. | 37 |
| Total | 74 |
Baseline characteristics
| Characteristic | ST-CI | Total | PATH |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 37 Participants | 74 Participants | 37 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 71 Participants | 34 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 | 6 Participants | 13 Participants | 7 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 31 Participants | 61 Participants | 30 Participants |
| Region of Enrollment United States | 37 participants | 74 participants | 37 participants |
| Sex: Female, Male Female | 25 Participants | 51 Participants | 26 Participants |
| Sex: Female, Male Male | 12 Participants | 23 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 37 | 1 / 37 |
| other Total, other adverse events | 0 / 37 | 0 / 37 |
| serious Total, serious adverse events | 8 / 37 | 10 / 37 |
Outcome results
Primary
Montgomery Asberg Depression Scale (MADRS)
Montgomery Asberg Depression Scale (MADRS) is a depression rating scale. Range of scores (1-35). Higher scores represent worse outcome (depression).
Time frame: 12 week outcome
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PATH | Montgomery Asberg Depression Scale (MADRS) | 10.46 Units on MADRS scale | Standard Error 1.07 |
| ST-CI | Montgomery Asberg Depression Scale (MADRS) | 15.53 Units on MADRS scale | Standard Error 1.07 |
p-value: 0.00595% CI: [0.13, 1.06]Mixed Models Analysis
Primary
WHO Disability Assessment Schedule (WHODAS)-II
WHO Disability Assessment Schedule (WHODAS)-II is a disability scale. Range of scores: 12-43. Higher scores represent worse outcome (disability).
Time frame: 12-week outcome
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PATH | WHO Disability Assessment Schedule (WHODAS)-II | 27.37 WHODAS-II units | Standard Error 1.16 |
| ST-CI | WHO Disability Assessment Schedule (WHODAS)-II | 32.14 WHODAS-II units | Standard Error 1.15 |
p-value: 0.00195% CI: [0.2, 1.14]Mixed Models Analysis
Secondary
Hamilton Depression Rating Scale
Hamilton Depression Rating Scale is a scale measuring depression severity. Range of scores: 1-33. Higher scores reflect worse outcome (depression).
Time frame: Outcome at 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PATH | Hamilton Depression Rating Scale | 11.16 units on a scale | Standard Deviation 6.9 |
| ST-CI | Hamilton Depression Rating Scale | 15.03 units on a scale | Standard Deviation 7.3 |
p-value: 0.0268Wilcoxon (Mann-Whitney)
Secondary
Sheehan Disability Scale.
Sheehan Disability Scale is a measure of disability. Range of scores: 0-20. Higher scores reflect worse outcome (disability).
Time frame: Outcome at 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PATH | Sheehan Disability Scale. | 5.40 units on a scale | Standard Deviation 4.91 |
| ST-CI | Sheehan Disability Scale. | 12.16 units on a scale | Standard Deviation 3.87 |
p-value: <0.0001Wilcoxon (Mann-Whitney)