Treatment Resistant DepressionNCT02971150
Treatment Resistant Depression and Insomnia in Older Veterans
A study testing Brief Behavioral Treatment for Insomnia in people with Treatment Resistant Depression and Insomnia, run by VA Pittsburgh Healthcare System at 1 site in United States.
Trial summary
The purpose of this pilot study is to obtain information about older Veterans' preferences for treatment of depression and insomnia and to pilot test the feasibility and clinical effect of Brief Behavioral Treatment for Insomnia (BBTI) BBTI for older Veterans living with Treatment Resistant Depression (TRD) and… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Treatment Resistant Depression, Insomnia
- What is being tested?
- Brief Behavioral Treatment for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Mar 2017
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60
- Diagnosis of Major Depressive Disorder (MDD)
- Diagnosis of Insomnia Disorder
- Must have failed ≥ 1 antidepressant trial
Who cannot join
- Lifetime/current Bipolar I/II diagnosis
- Lifetime/current Schizophrenia Spectrum Disorder diagnosis
- Substance Use Disorder within past 3 months
- High Suicide Risk that cannot be safely managed
- Untreated Obstructive Sleep Apnea (OSA)
- Restless Legs Syndrome
- Rapid Eye Movement (REM) Sleep Behavior Disorder
- Active OR untreated Post Traumatic Stress Disorder (PTSD)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240
About this study
Official title: Treatment Resistant Depression and Insomnia in Older Veterans: A Pilot Study
The purpose of this pilot study is to obtain information about older Veterans' preferences for treatment of depression and insomnia and to pilot test the feasibility and clinical effect of Brief Behavioral Treatment for Insomnia (BBTI) BBTI for older Veterans living with Treatment Resistant Depression (TRD) and insomnia.
Read the detailed description
Quantitative and qualitative methods will be used to obtain information to aid in developing treatment approaches appropriate for older Veterans with TRD and insomnia. Qualitative data will be gathered to better understand Veterans' preferences for treatment approaches, particularly relating to preference for pharmacotherapy versus augmentation with a behavioral intervention such as BBTI. Using a Randomized Controlled Trial (RCT) design, we will test whether augmentation with BBTI will be acceptable to older Veterans and improve treatment response in those whose depression has not improved with antidepressant pharmacotherapy alone and assess for an association between preference and treatment response. Our aims and hypotheses are:
Aim 1: To characterize the depression, insomnia, and relevant clinical and neuropsychiatric characteristics of older Veterans with TRD.
H1a: In Veterans with TRD, Antidepressant History Form (ATHF) scores will have a positive association with Montgomery-Asberg Depression Rating scale (MADRS) scores.
H1b: In Veterans with TRD, MADRS scores will have a positive association with Insomnia Severity Index (ISI) scores.
Aim 2: Perform qualitative interviews in older Veterans to collect information about their views of their depression and insomnia and attitudes and preferences for treatment of both depression and insomnia.
Aim 3: To examine the feasibility of using BBTI to treat Veterans with TRD and insomnia.
H3a: Use of BBTI will be feasible in older adults with TRD as defined by acceptability and retention.
Aim 4: To determine if antidepressant augmentation with BBTI leads to improvement in scores on MADRS and ISI scales in older Veterans receiving BBTI versus those receiving only antidepressant optimization.
H4a: Augmentation with BBTI will improve both PHQ-9 and ISI scores relative treatment with antidepressant alone.
- Conditions
- Treatment Resistant Depression, Insomnia
- Being tested
- Brief Behavioral Treatment for Insomnia
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Behavioral Treatment for InsomniaBehavioural
Also called BBTI
| Study group | Role | What they receive |
|---|---|---|
| BBTI | Experimental | Participants will receive Brief Behavioral Treatment for Insomnia (BBTI). This will be administered over the course of 4 weeks. BBTI is based on the concepts of sleep restriction and stimulus control. The first and third session are in person and the 2 and 4th session are conducted over the phone. Throughout the treatment, participants will complete daily sleep dairies. After 4 weeks of treatment, participants randomized to this group will cross over to the no intervention group and will be called once a week to assess mood and sleep symptoms. Receives: Behavioral: Brief Behavioral Treatment for Insomnia |
| Control | No intervention | Participants will not receive treatment. They will be contacted by phone once a week to complete assessments of mood and sleep. After 4 weeks, they will cross over to the experimental BBTI group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PHQ-9 ( depression)
Measured: 8 weeks
ISI score ( insomnia)
Measured: 8 weeks
Secondary outcomes (2)
Short Form Survey (SF-12) SF-12 ( quality of life)
Measured: 8 weeks
Emotional Closeness Questionnaire ( ECQ)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Pittsburgh Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971150
- Sponsor's protocol ID
- PRO0001567
- Status last verified
- May 2017
- First submitted
- 17 Nov 2016
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Resistant Depression and Insomnia in Older Veterans: A Pilot Study
- ClinicalTrials.gov ID
- NCT02971150
- Acronym / sponsor ID
- PRO0001567
- Conditions
- Treatment Resistant Depression, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- VA Pittsburgh Healthcare SystemUS federal agency
- Study start
- Apr 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 22 Nov 2016 (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.
The purpose of this pilot study is to obtain information about older Veterans' preferences for treatment of depression and insomnia and to pilot test the feasibility and clinical effect of Brief Behavioral Treatment for Insomnia (BBTI) BBTI for older Veterans living with Treatment Resistant Depression (TRD) and insomnia.
Detailed description
Quantitative and qualitative methods will be used to obtain information to aid in developing treatment approaches appropriate for older Veterans with TRD and insomnia. Qualitative data will be gathered to better understand Veterans' preferences for treatment approaches, particularly relating to preference for pharmacotherapy versus augmentation with a behavioral intervention such as BBTI. Using a Randomized Controlled Trial (RCT) design, we will test whether augmentation with BBTI will be acceptable to older Veterans and improve treatment response in those whose depression has not improved with antidepressant pharmacotherapy alone and assess for an association between preference and treatment response. Our aims and hypotheses are:
Aim 1: To characterize the depression, insomnia, and relevant clinical and neuropsychiatric characteristics of older Veterans with TRD.
H1a: In Veterans with TRD, Antidepressant History Form (ATHF) scores will have a positive association with Montgomery-Asberg Depression Rating scale (MADRS) scores.
H1b: In Veterans with TRD, MADRS scores will have a positive association with Insomnia Severity Index (ISI) scores.
Aim 2: Perform qualitative interviews in older Veterans to collect information about their views of their depression and insomnia and attitudes and preferences for treatment of both depression and insomnia.
Aim 3: To examine the feasibility of using BBTI to treat Veterans with TRD and insomnia.
H3a: Use of BBTI will be feasible in older adults with TRD as defined by acceptability and retention.
Aim 4: To determine if antidepressant augmentation with BBTI leads to improvement in scores on MADRS and ISI scales in older Veterans receiving BBTI versus those receiving only antidepressant optimization.
H4a: Augmentation with BBTI will improve both PHQ-9 and ISI scores relative treatment with antidepressant alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BBTI | Experimental | Behavioral: Brief Behavioral Treatment for InsomniaParticipants will receive Brief Behavioral Treatment for Insomnia (BBTI). This will be administered over the course of 4 weeks. BBTI is based on the concepts of sleep restriction and stimulus control. The first and third session are in person and the 2 and 4th session are conducted over the phone. Throughout the treatment, participants will complete daily sleep dairies. After 4 weeks of treatment, participants randomized to this group will cross over to the no intervention group and will be called once a week to assess mood and sleep symptoms. |
| Control | No intervention | –Participants will not receive treatment. They will be contacted by phone once a week to complete assessments of mood and sleep. After 4 weeks, they will cross over to the experimental BBTI group. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (8 listed)
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 |
|---|---|---|
| Brief Behavioral Treatment for InsomniaAlso: BBTI | Behavioural | BBTI |
Primary outcome
PHQ-9 ( depression)
Time frame: 8 weeks
ISI score ( insomnia)
Time frame: 8 weeks
2 secondary outcomes
Short Form Survey (SF-12) SF-12 ( quality of life)
Time frame: 8 weeks
Emotional Closeness Questionnaire ( ECQ)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Treatment for Insomnia in people with Treatment Resistant Depression and Insomnia, run by VA Pittsburgh Healthcare System 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 1 Jun 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PHQ-9 ( depression) (time frame: 8 weeks). The study lists 2 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 1 Jun 2017.