Treatment of Insomnia and Depression in Elders (TIDE)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Depression, Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 50 - 100 |
| Updated: | 4/21/2016 |
| Start Date: | June 2012 |
Insomnia and depression are two of the most prevalent mental health disorders and often
co-occur.
Health disparities in rural America and among African-Americans are well documented. The
investigators propose an R34 exploratory project to test the feasibility of delivering
high-fidelity insomnia and depression psychological services to an underserved population.
Treatment of Insomnia and Depression in Elders (TIDE) is a pilot study that will treat
rural, predominantly African-American older adults who present to their primary care
physician with co-occurring insomnia/depression. Stage 1 will be an uncontrolled case study
series (n = 10) focusing on treatment development/refinement and patient acceptability. In
stage 2, feasibility will be experimentally tested with 46 participants randomized to
integrated cognitive-behavior therapy (CBT) + usual care or to usual care only in an
effectiveness pilot study. The treatment will combine/integrate compact CBT for insomnia
(including relaxation, sleep restriction, and stimulus control) and for depression
(including cognitive therapy and behavioral activation). The experimental intervention
comprises delivering CBT services by videoconferencing to patients in primary care settings
who live in rural areas. Treatment will be evaluated by pre, post, and follow-up self report
instruments on insomnia, depression, and quality of life. In addition, the stage 1 pilot
will use investigator designed quantitative and qualitative measures to evaluate critical
process variables including patient acceptability of the video format, patient acceptability
of the treatments, and obstacles to adherence. Depending on stage 1 data, these measures may
be incorporated into stage 2 as well. Several innovative features of this exploratory
project include: intervening with CBT on both disorders hoping to gain a synergy by their
combined presentation; use of telehealth to deliver treatment to distant locations;
translation of efficacy findings to an effectiveness trial; treatment will be delivered in
the primary care setting, the preferred locale of rural, older adults; the study will extend
knowledge of the range of CBT applications by enrolling under-represented groups with
respect to ethnicity, literacy, and financial resources.
The primary aims of this project are (1) to determine the feasibility and maximal therapy
characteristics of integrated CBT for co-occurring insomnia/depression in both the case
study series (stage 1) and the experimental investigation (stage 2), (2) collect pilot data
on whether participants receiving integrated CBT + usual care show comparable or greater
reductions in insomnia symptoms compared to participants receiving usual care at
posttreatment and follow-up, and (3) collect pilot data on whether participants receiving
integrated CBT + usual care show comparable or greater reductions in depression symptoms
compared to participants receiving usual care at posttreatment and follow-up.
co-occur.
Health disparities in rural America and among African-Americans are well documented. The
investigators propose an R34 exploratory project to test the feasibility of delivering
high-fidelity insomnia and depression psychological services to an underserved population.
Treatment of Insomnia and Depression in Elders (TIDE) is a pilot study that will treat
rural, predominantly African-American older adults who present to their primary care
physician with co-occurring insomnia/depression. Stage 1 will be an uncontrolled case study
series (n = 10) focusing on treatment development/refinement and patient acceptability. In
stage 2, feasibility will be experimentally tested with 46 participants randomized to
integrated cognitive-behavior therapy (CBT) + usual care or to usual care only in an
effectiveness pilot study. The treatment will combine/integrate compact CBT for insomnia
(including relaxation, sleep restriction, and stimulus control) and for depression
(including cognitive therapy and behavioral activation). The experimental intervention
comprises delivering CBT services by videoconferencing to patients in primary care settings
who live in rural areas. Treatment will be evaluated by pre, post, and follow-up self report
instruments on insomnia, depression, and quality of life. In addition, the stage 1 pilot
will use investigator designed quantitative and qualitative measures to evaluate critical
process variables including patient acceptability of the video format, patient acceptability
of the treatments, and obstacles to adherence. Depending on stage 1 data, these measures may
be incorporated into stage 2 as well. Several innovative features of this exploratory
project include: intervening with CBT on both disorders hoping to gain a synergy by their
combined presentation; use of telehealth to deliver treatment to distant locations;
translation of efficacy findings to an effectiveness trial; treatment will be delivered in
the primary care setting, the preferred locale of rural, older adults; the study will extend
knowledge of the range of CBT applications by enrolling under-represented groups with
respect to ethnicity, literacy, and financial resources.
The primary aims of this project are (1) to determine the feasibility and maximal therapy
characteristics of integrated CBT for co-occurring insomnia/depression in both the case
study series (stage 1) and the experimental investigation (stage 2), (2) collect pilot data
on whether participants receiving integrated CBT + usual care show comparable or greater
reductions in insomnia symptoms compared to participants receiving usual care at
posttreatment and follow-up, and (3) collect pilot data on whether participants receiving
integrated CBT + usual care show comparable or greater reductions in depression symptoms
compared to participants receiving usual care at posttreatment and follow-up.
Inclusion Criteria:
- 50 years of age or older,
- resident of the Black Belt or adjacent counties and receiving services from one of
our primary care collaborators
- absence of significant cognitive impairment as indicated by a score of 24 or higher
(17 or higher for those with only an eighth grade education) on the Mini-Mental
Status Examination (MMSE; Folstein, Folstein, & McHugh, 1975
- not currently receiving psychological treatment,
- absence of serious suicidality
- concurrent psychiatric/medical disorders are not automatic disqualifiers unless they
prevent participants from attending CBT therapy sessions or impede data collection,
- a referral from their primary care physician indicating presence of both insomnia and
depression symptoms of sufficient significance to warrant initiation or continuance
of primary care treatment for newly emergent or residual symptoms. Persons who are
currently receiving pharmacotherapy for insomnia and/or depression must evidence
residual symptoms of both disorders of sufficient magnitude to be evaluated as
clinically significant and warranting further treatment by their primary care
physician.
Exclusion Criteria:
- age is below 50
- not receiving services from one of our primary care collaborators
- significant cognitive impairment is present as indicated by a score of 23 or lower
(16 or lower for those with only an eighth grade education) on the MMSE
- currently receiving psychological treatment
- presence of serious suicidality
- intrusive and unstable concurrent psychiatric/medical disorders
- primary care physician declines to refer
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