DepressionTIDENCT01648049
Treatment of Insomnia and Depression in Elders (TIDE)
A study testing Integrated Cognitive Behavioral Therapy (CBT) and Treatment as usual in people with Depression and Insomnia, run by University of Alabama, Tuscaloosa at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Depression, Insomnia
- What is being tested?
- Integrated Cognitive Behavioral Therapy (CBT) and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Depression, Insomnia
- Being tested
- Integrated Cognitive Behavioral Therapy (CBT), Treatment as usual
- Medical subject headings
- Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Cognitive Behavioral Therapy (CBT)Behavioural
CBT treatment is an abbreviated protocol based on manualized, evidence-based treatments for geriatric insomnia (Lichstein \& Morin, 2000) and geriatric depression (Thompson, Gallagher-Thompson, \& Dick, 1995).
Treatment as usualBehavioural
Standard Care - Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| CBT | Experimental | Cognitive behavior therapy for both insomnia and depression featuring stimulus control and cognitive therapy. Receives: Behavioral: Integrated Cognitive Behavioral Therapy (CBT) |
| Treatment as Usual | Active comparator | No additional treatment besides regular care. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
Insomnia Measure
Measured: 3-month follow-up (23weeks post-treatment)
Hamilton Depression Scale
Depression measure
Measured: 10 weeks Post-treatment
Hamilton Depression Scale
Depression Measure
Measured: 3 Month follow-up (23 weeks post treatment)
Insomnia Severity Index
Insomnia Measure
Measured: 10 weeks Post-treatment
Secondary outcomes (9)
GDS
Self-reported Geriatric Depression Scale
Measured: Pre-Treatment (Baseline/Week 0)
SOL
self-reported Sleep Onset Latency
Measured: Pre-Treatment (Baseline/Week 0)
WASO
Wake-time After Sleep Onset
Measured: Pre-Treatment (Baseline/Week 0)
SOL
Self-reported Sleep onset latency
Measured: 10 weeks Post-treatment
SOL
Self-reported Sleep onset latency
Measured: 3-month follow-up (23weeks post-treatment)
GDS
Self Reported Geriatric Depression Scale
Measured: 10 weeks Post-treatment
GDS
Self-reported Geriatric Depression Scale
Measured: 3-month follow-up (23weeks post-treatment)
WASO
Wake-time After Sleep Onset
Measured: 10 weeks Post-treatment
WASO
Wake-time After Sleep Onset
Measured: 3-month follow-up (23weeks post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Kenneth L. Lichstein, Ph.D., Principal investigator, University of Alabama, TuscaloosaForrest Scogin, Ph.D., Principal investigator, University of Alabama, Tuscaloosa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648049
- Sponsor's protocol ID
- 10-0309
- Other IDs
- 1R34MH086643-01A2
- Acronym
- TIDE
- Status last verified
- Nov 2015
- First submitted
- 26 Jun 2012
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Insomnia and Depression in Elders (TIDE)
- ClinicalTrials.gov ID
- NCT01648049
- Acronym / sponsor ID
- TIDE / 10-0309
- Conditions
- Depression, Insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2012
- Primary completion
- Mar 2015 (actual)
- First posted
- 24 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT | Experimental | Behavioral: Integrated Cognitive Behavioral Therapy (CBT)Cognitive behavior therapy for both insomnia and depression featuring stimulus control and cognitive therapy. |
| Treatment as Usual | Active comparator | Behavioral: Treatment as usualNo additional treatment besides regular care. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Cognitive Behavioral Therapy (CBT)CBT treatment is an abbreviated protocol based on manualized, evidence-based treatments for geriatric insomnia (Lichstein \& Morin, 2000) and geriatric depression (Thompson, Gallagher-Thompson, \& Dick, 1995). | Behavioural | CBT |
| Treatment as usualStandard Care - Treatment as usual | Behavioural | Treatment as Usual |
Primary outcome
Insomnia Severity Index
Time frame: 3-month follow-up (23weeks post-treatment)
Insomnia Measure
Hamilton Depression Scale
Time frame: 10 weeks Post-treatment
Depression measure
Hamilton Depression Scale
Time frame: 3 Month follow-up (23 weeks post treatment)
Depression Measure
Insomnia Severity Index
Time frame: 10 weeks Post-treatment
Insomnia Measure
9 secondary outcomes
GDS
Time frame: Pre-Treatment (Baseline/Week 0)
SOL
Time frame: Pre-Treatment (Baseline/Week 0)
WASO
Time frame: Pre-Treatment (Baseline/Week 0)
SOL
Time frame: 10 weeks Post-treatment
SOL
Time frame: 3-month follow-up (23weeks post-treatment)
GDS
Time frame: 10 weeks Post-treatment
GDS
Time frame: 3-month follow-up (23weeks post-treatment)
WASO
Time frame: 10 weeks Post-treatment
WASO
Time frame: 3-month follow-up (23weeks post-treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth L. Lichstein, Ph.D. principal investigator
University of Alabama, Tuscaloosa
Forrest Scogin, Ph.D. principal investigator
University of Alabama, Tuscaloosa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Cognitive Behavioral Therapy (CBT) and Treatment as usual in people with Depression and Insomnia, run by University of Alabama, Tuscaloosa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: 3-month follow-up (23weeks post-treatment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.