DepressionNCT03091582
Brief Inpatient Psychotherapy for Depression
A study testing Cognitive factors, Behavioral factors and Increase engagement of pleasant events in people with Depression, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The primary objective of the proposed pilot study is to seek to compare the efficacy of two brief psychological therapies during inpatient hospitalization - cognitive behavioral therapy (CBT) versus Behavioral Activation for Medical Inpatients with Depression (BAMID or BA) - for improving depressive symptoms… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Depression
- What is being tested?
- Cognitive factors, Behavioral factors and Increase engagement of pleasant events
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 1 Jan 2018
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Adults from 18-80; 2) PHQ>12; 3) Medical conditions needing inpatient medical care.
Who cannot join
- 1) Patients who unable to provide informed consent; 2) Patients deemed in critical medical condition; 3) Conditions that preclude administration of the PHQ for depression screening (e.g., delirium, dementia, acute stroke, loss of consciousness, substance intoxication or withdrawal, agitation, psychotic disorders); 4) Homeless patients, as patient follow-up by mail would be difficult; 5) Meeting criteria for involuntary admission due to imminent danger to self or others, as they are transferred to offsite psychiatric facilities.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Pilot Testing of a Rapid-Onset Psychological Therapy Intervention for Depressed Medical Inpatients
The primary objective of the proposed pilot study is to seek to compare the efficacy of two brief psychological therapies during inpatient hospitalization - cognitive behavioral therapy (CBT) versus Behavioral Activation for Medical Inpatients with Depression (BAMID or BA) - for improving depressive symptoms, functioning, and quality of life (QOL). The treatments will consist of four sessions, which will be delivered during hospitalization.
Read the detailed description
First Visit (after Identification by PHQ Intake Score): If, after being clearly told that participation in the study will not impact subsequent care at CSMC, the patient agrees to participate, the patient will review and sign the informed consent form. Next, the subject will be randomized to either receive CBT or BA therapy, and scheduled for CBT or BA therapy sessions. These sessions will be provided subsequently by an attending psychiatrist or health psychologist in Psychiatry (currently Drs. IsHak, Danovitch, Hedrick, Chaudhry, and Sumner).
Study Visits #'s 2 - 5: Details about the four therapy sessions are listed below. Study Participants will participate in therapy in the hospital room, with no other staff or patients present. Family and friends will not be allowed to be present. If nurses need to enter the room during the therapy session, therapy will be temporarily suspended. The treating clinician will choose a time for therapy that minimizes interruption by examining the patient's schedule and consulting with the attending psychiatrist.
At the end of Visit #5, the study participant will also be offered a referral, by the attending psychiatrist or health psychologist, to a community-based therapist who is not affiliated with CSMC, and if the subject decides to participate, to continue therapy after discharge. The community-based therapist may or may not utilize the same approach utilized during the study. Community-based therapists will be selected among those who are known in the community to the treating psychiatrist/health psychologist, for whom the treating psychiatrist/psychologist can personally vouch. The treating psychiatrist/psychologist may select a community-based therapist whom the patient can afford, or is covered by the patient's insurance. Study participants and therapist will work together to select a community-based provider for use after discharge. The community-based therapy is not part of the research study and, therefore, subjects will be told that seeking this additional therapy is up to the subject and any potential costs related to these sessions will be covered by the subject and/or their insurance company. In the event of early discharge based on medical reasons, the therapy will be concluded and the patient will be referred to the community-based therapist. This will be considered an incomplete delivery of the sessions (early withdrawal).
Treatments Both treatments will consist of four sessions during inpatient hospitalization.
Cognitive Behavioral Therapy (CBT)
- Session one = Will last 1.5 hours and focus on depression psychoeducation, orient the study participant to brief CBT, treatment goal settings, and identification of maladaptive thoughts and beliefs. Solicit participant feedback and set agenda. Homework includes patient identifying automatic thoughts and core beliefs and associated emotions. Support and encouragement will be provided.
- Session two = Will last 50 min and will review homework, introduce cognitive strategies to test the accuracy of those beliefs by identifying and modifying negative thoughts and beliefs that give rise to them. Teach and practice identifying ruminative and catastrophizing thoughts. Will also review cognitive distortions and provide support and encouragement. Homework includes participants identifying ruminative and catastrophizing thoughts and challenging those thoughts. Will also teach relaxation techniques (e.g. deep breathing, guided imagery). Support and encouragement will be provided.
- Session three = Will last 50min and focus on reviewing homework, monitoring moods and activities, planning of exercises to test negative beliefs, and thought records to identify and examine the accuracy of negative automatic thoughts and underlying beliefs. Teach problem-solving skills Provide support and encouragement.
- Session four = Will last 50 minutes and focus on reviewing and consolidating newly learning cognitive strategies. Practicing. Generate plan for change and provide support and encouragement.
Behavioral Activation for Medical Inpatients with Depression (BAMID or BA)
- Session one = Will last 1.5 hours of depression psychoeducation (recognition of depression), treatment rationale, assessment of baseline activity level. Identification of factors that contribute to or exacerbate depressive behavior (e.g. withdrawal from friends or family), activity and goal selection, assessment of daily activities and environmental support prior to hospitalization, identification of pleasurable activities in which engaged (could be making a telephone call, journaling, reading, coloring, or if medically stable, having a plaza visit) and homework assignment (reporting a numerical rating of both enjoyment and importance for each activity identified). Provide support and encouragement.
- Session two = Will last 50 min and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement. Homework will be to chart progress of activity engagement by duration, frequency, self-reported level of mastery. Provide support and encouragement.
- Session three =Will last 50 min. Session will include a review of engagement in 3-5 activities considered rewarding and important for values. Discussion of how to continue activities, monitor depressive symptoms and identify rewards for activity engagement. Provide support and encouragement.
- Session Four = 50 minutes. Will review progress, provide support and encouragement and plan for continued engagement post-discharge. Provide support and encouragement.
Study Visit #6 - Discharge: Before discharge, participants will complete three questionnaires administered by study staff, as follows: 1) a paper version of the PHQ-9 depression inventory, to assess depressive symptoms; 2) the National Institute of Health Patient Reported Outcome Measurement Information System (NIH PROMIS) 10-item Global Health scale, to assess QOL (PROMIS-10); and 3) the World Health Organization Disability Assessment Schedule (WHODAS) 2.0, to assess functioning. These measures will serve as a baseline for comparison with data obtained 90 days later. Participants will also be asked whether they agree to be contacted in 90 days for follow-up assessment; those who agree will be contacted by study staff for Visit #7.
Study Visit #7 - After Discharge: 90 days after the study participant is discharged from the hospital, study staff will contact the subject by phone to inquire about whether they utilized the referral to community-based therapy or not; those who did use the referral will be asked the number of sessions completed over the last 90 days, and the frequency of those sessions. In addition, study staff will also ask whether the subject started antidepressant medication after they left the hospital. If so, they will be asked what the medication and dosage was and how much of the medication they took and (assuming a 30-day dosage), how many pills they have left from the current bottle and when this bottle was prescribed. Any mental health issues that arise during this phone call will be referred to the original attending psychiatrist, or to the community-based therapist if the study participant chose to utilize the referral. Next, the staff member will ask if the study participant is interested in completing study measures over the phone, or on paper. If the subject agrees, the study staff member will administer the same three questionnaires given before discharge over the phone, taking approximately 30 minutes. If the subject prefers to complete these on paper, questionnaires will be mailed by US postal mail along with a self-addressed stamped envelope, and the phone call will end after 5 minutes. These data will be collected and de-identified for analysis.
4 Anticipated Level of Risk:
- Conditions
- Depression
- Being tested
- Cognitive factors, Behavioral factors, Increase engagement of pleasant events
- Keywords
- Psychological Therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive factorsBehavioural
The Cognitive-Behavioral Therapy (CBT) intervention will focus on catastrophizing and rumination. CBT emphasizes the role of cognitive and behavioral factors on affective distress
Behavioral factorsBehavioural
The Cognitive-Behavioral Therapy (CBT) intervention will focus on catastrophizing and rumination. Behavioral factors on affective distress.
Increase engagement of pleasant eventsBehavioural
Behavioral Activation is grounded in learning theory and posits that lack of positive/active engagement of the person with his/her environment contributes to an increase in avoidant or passive behaviors and decreased reinforcement. An empirically validated treatment, behavioral activation reduces depressive symptoms and increase engagement of pleasant events.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy | Experimental | The Cognitive-Behavioral Therapy (CBT) intervention will focus on catastrophizing and rumination. CBT emphasizes the role of cognitive factors and behavioral factors on affective distress. Receives: Behavioral: Cognitive factors; Behavioral: Behavioral factors |
| Behavioral Activation | Experimental | Behavioral Activation is grounded in learning theory and posits that lack of positive/active engagement of the person with his/her environment contributes to an increase in avoidant or passive behaviors and decreased reinforcement. An empirically validated treatment, behavioral activation reduces depressive symptoms and increase engagement of pleasant events. Receives: Behavioral: Increase engagement of pleasant events |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptom Severity
The PHQ-9 is used to measure depressive symptoms
Measured: 12 weeks
Secondary outcomes (2)
Functioning
WHODAS is used to measure functioning
Measured: 12 weeks
Overall Health and Quality of life (QOL)
NIH-PROMIS-10 is used to measure the overall health and QOL
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start1 Jul 2017
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
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.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- 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
- Model description
- After being clearly told that participation in the study will not impact subsequent care at CSMC, the patient agrees to participate, the patient will review and sign the informed consent form. Next, the patient will be randomized to either receive CBT or BA therapy, and scheduled for CBT or BA therapy sessions.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waguih IsHak, Cedars-Sinai Medical Center
- Investigators
- Waguih W IsHak, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091582
- Sponsor's protocol ID
- Pro00046076
- Status last verified
- Sep 2018
- First submitted
- 21 Mar 2017
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing of a Rapid-Onset Psychological Therapy Intervention for Depressed Medical Inpatients
- ClinicalTrials.gov ID
- NCT03091582
- Acronym / sponsor ID
- Pro00046076
- Conditions
- Depression
- Keywords
- Psychological Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 27 Mar 2017 (actual)
- 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 primary objective of the proposed pilot study is to seek to compare the efficacy of two brief psychological therapies during inpatient hospitalization - cognitive behavioral therapy (CBT) versus Behavioral Activation for Medical Inpatients with Depression (BAMID or BA) - for improving depressive symptoms, functioning, and quality of life (QOL). The treatments will consist of four sessions, which will be delivered during hospitalization.
Detailed description
First Visit (after Identification by PHQ Intake Score): If, after being clearly told that participation in the study will not impact subsequent care at CSMC, the patient agrees to participate, the patient will review and sign the informed consent form. Next, the subject will be randomized to either receive CBT or BA therapy, and scheduled for CBT or BA therapy sessions. These sessions will be provided subsequently by an attending psychiatrist or health psychologist in Psychiatry (currently Drs. IsHak, Danovitch, Hedrick, Chaudhry, and Sumner).
Study Visits #'s 2 - 5: Details about the four therapy sessions are listed below. Study Participants will participate in therapy in the hospital room, with no other staff or patients present. Family and friends will not be allowed to be present. If nurses need to enter the room during the therapy session, therapy will be temporarily suspended. The treating clinician will choose a time for therapy that minimizes interruption by examining the patient's schedule and consulting with the attending psychiatrist.
At the end of Visit #5, the study participant will also be offered a referral, by the attending psychiatrist or health psychologist, to a community-based therapist who is not affiliated with CSMC, and if the subject decides to participate, to continue therapy after discharge. The community-based therapist may or may not utilize the same approach utilized during the study. Community-based therapists will be selected among those who are known in the community to the treating psychiatrist/health psychologist, for whom the treating psychiatrist/psychologist can personally vouch. The treating psychiatrist/psychologist may select a community-based therapist whom the patient can afford, or is covered by the patient's insurance. Study participants and therapist will work together to select a community-based provider for use after discharge. The community-based therapy is not part of the research study and, therefore, subjects will be told that seeking this additional therapy is up to the subject and any potential costs related to these sessions will be covered by the subject and/or their insurance company. In the event of early discharge based on medical reasons, the therapy will be concluded and the patient will be referred to the community-based therapist. This will be considered an incomplete delivery of the sessions (early withdrawal).
Treatments Both treatments will consist of four sessions during inpatient hospitalization.
Cognitive Behavioral Therapy (CBT)
- Session one = Will last 1.5 hours and focus on depression psychoeducation, orient the study participant to brief CBT, treatment goal settings, and identification of maladaptive thoughts and beliefs. Solicit participant feedback and set agenda. Homework includes patient identifying automatic thoughts and core beliefs and associated emotions. Support and encouragement will be provided.
- Session two = Will last 50 min and will review homework, introduce cognitive strategies to test the accuracy of those beliefs by identifying and modifying negative thoughts and beliefs that give rise to them. Teach and practice identifying ruminative and catastrophizing thoughts. Will also review cognitive distortions and provide support and encouragement. Homework includes participants identifying ruminative and catastrophizing thoughts and challenging those thoughts. Will also teach relaxation techniques (e.g. deep breathing, guided imagery). Support and encouragement will be provided.
- Session three = Will last 50min and focus on reviewing homework, monitoring moods and activities, planning of exercises to test negative beliefs, and thought records to identify and examine the accuracy of negative automatic thoughts and underlying beliefs. Teach problem-solving skills Provide support and encouragement.
- Session four = Will last 50 minutes and focus on reviewing and consolidating newly learning cognitive strategies. Practicing. Generate plan for change and provide support and encouragement.
Behavioral Activation for Medical Inpatients with Depression (BAMID or BA)
- Session one = Will last 1.5 hours of depression psychoeducation (recognition of depression), treatment rationale, assessment of baseline activity level. Identification of factors that contribute to or exacerbate depressive behavior (e.g. withdrawal from friends or family), activity and goal selection, assessment of daily activities and environmental support prior to hospitalization, identification of pleasurable activities in which engaged (could be making a telephone call, journaling, reading, coloring, or if medically stable, having a plaza visit) and homework assignment (reporting a numerical rating of both enjoyment and importance for each activity identified). Provide support and encouragement.
- Session two = Will last 50 min and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement. Homework will be to chart progress of activity engagement by duration, frequency, self-reported level of mastery. Provide support and encouragement.
- Session three =Will last 50 min. Session will include a review of engagement in 3-5 activities considered rewarding and important for values. Discussion of how to continue activities, monitor depressive symptoms and identify rewards for activity engagement. Provide support and encouragement.
- Session Four = 50 minutes. Will review progress, provide support and encouragement and plan for continued engagement post-discharge. Provide support and encouragement.
Study Visit #6 - Discharge: Before discharge, participants will complete three questionnaires administered by study staff, as follows: 1) a paper version of the PHQ-9 depression inventory, to assess depressive symptoms; 2) the National Institute of Health Patient Reported Outcome Measurement Information System (NIH PROMIS) 10-item Global Health scale, to assess QOL (PROMIS-10); and 3) the World Health Organization Disability Assessment Schedule (WHODAS) 2.0, to assess functioning. These measures will serve as a baseline for comparison with data obtained 90 days later. Participants will also be asked whether they agree to be contacted in 90 days for follow-up assessment; those who agree will be contacted by study staff for Visit #7.
Study Visit #7 - After Discharge: 90 days after the study participant is discharged from the hospital, study staff will contact the subject by phone to inquire about whether they utilized the referral to community-based therapy or not; those who did use the referral will be asked the number of sessions completed over the last 90 days, and the frequency of those sessions. In addition, study staff will also ask whether the subject started antidepressant medication after they left the hospital. If so, they will be asked what the medication and dosage was and how much of the medication they took and (assuming a 30-day dosage), how many pills they have left from the current bottle and when this bottle was prescribed. Any mental health issues that arise during this phone call will be referred to the original attending psychiatrist, or to the community-based therapist if the study participant chose to utilize the referral. Next, the staff member will ask if the study participant is interested in completing study measures over the phone, or on paper. If the subject agrees, the study staff member will administer the same three questionnaires given before discharge over the phone, taking approximately 30 minutes. If the subject prefers to complete these on paper, questionnaires will be mailed by US postal mail along with a self-addressed stamped envelope, and the phone call will end after 5 minutes. These data will be collected and de-identified for analysis.
4 Anticipated Level of Risk:
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After being clearly told that participation in the study will not impact subsequent care at CSMC, the patient agrees to participate, the patient will review and sign the informed consent form. Next, the patient will be randomized to either receive CBT or BA therapy, and scheduled for CBT or BA therapy sessions.
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy | Experimental | Behavioral: Cognitive factors, Behavioral: Behavioral factorsThe Cognitive-Behavioral Therapy (CBT) intervention will focus on catastrophizing and rumination. CBT emphasizes the role of cognitive factors and behavioral factors on affective distress. |
| Behavioral Activation | Experimental | Behavioral: Increase engagement of pleasant eventsBehavioral Activation is grounded in learning theory and posits that lack of positive/active engagement of the person with his/her environment contributes to an increase in avoidant or passive behaviors and decreased reinforcement. An empirically validated treatment, behavioral activation reduces depressive symptoms and increase engagement of pleasant events. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Adults from 18-80; 2) PHQ>12; 3) Medical conditions needing inpatient medical care.
Key exclusion criteria (1 listed)
- 1) Patients who unable to provide informed consent; 2) Patients deemed in critical medical condition; 3) Conditions that preclude administration of the PHQ for depression screening (e.g., delirium, dementia, acute stroke, loss of consciousness, substance intoxication or withdrawal, agitation, psychotic disorders); 4) Homeless patients, as patient follow-up by mail would be difficult; 5) Meeting criteria for involuntary admission due to imminent danger to self or others, as they are transferred to offsite psychiatric facilities.
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 |
|---|---|---|
| Cognitive factorsThe Cognitive-Behavioral Therapy (CBT) intervention will focus on catastrophizing and rumination. CBT emphasizes the role of cognitive and behavioral factors on affective distress | Behavioural | Cognitive behavioral therapy |
| Behavioral factorsThe Cognitive-Behavioral Therapy (CBT) intervention will focus on catastrophizing and rumination. Behavioral factors on affective distress. | Behavioural | Cognitive behavioral therapy |
| Increase engagement of pleasant eventsBehavioral Activation is grounded in learning theory and posits that lack of positive/active engagement of the person with his/her environment contributes to an increase in avoidant or passive behaviors and decreased reinforcement. An empirically validated treatment, behavioral activation reduces depressive symptoms and increase engagement of pleasant events. | Behavioural | Behavioral Activation |
Primary outcome
Depressive Symptom Severity
Time frame: 12 weeks
The PHQ-9 is used to measure depressive symptoms
2 secondary outcomes
Functioning
Time frame: 12 weeks
Overall Health and Quality of life (QOL)
Time frame: 12 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 28 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Waguih W IsHak, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive factors, Behavioral factors and Increase engagement of pleasant events in people with Depression, run by Cedars-Sinai Medical Center 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 1 inclusion and 1 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 28 Sep 2018. 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?
Depressive Symptom Severity (time frame: 12 weeks). 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 28 Sep 2018.