N/A
Completed N=74
Problem Adaptation Therapy (PATH) vs. Supportive Therapy in Treating Depressed, Cognitively Impaired Older Adults
Source: ClinicalTrials.gov NCT00368940 ↗Enrolled (actual)
74
Serious AEs
24.3%
Results posted
Jul 2017
Primary outcomePrimary: Montgomery Asberg Depression Scale (MADRS) — 10.46; 15.53 Units on MADRS scale — p=0.005
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery Asberg Depression Scale (MADRS) |
10.46; 15.53 | 0.005 sig |
| PRIMARY WHO Disability Assessment Schedule (WHODAS)-II |
27.37; 32.14 | 0.001 sig |
| SECONDARY Hamilton Depression Rating Scale |
11.16; 15.03 | 0.0268 sig |
| SECONDARY Sheehan Disability Scale. |
5.40; 12.16 | <0.0001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00368940). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.