Brief Inpatient Psychotherapy for Depression

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)

1. 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.

2. 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.

3. 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.

4. 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)

1. 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.

2. 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.

3. 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.

4. 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:

Inclusion Criteria:

- 1) Adults from 18-80; 2) PHQ>12; 3) Medical conditions needing inpatient medical care.

Exclusion Criteria:

- 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.