Brief Inpatient Psychotherapy for Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

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, 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)

        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:
    

Intervention name(s): Cognitive factors; Behavioral factors; Increase engagement of pleasant events
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The Cognitive-Behavioral Therapy (CBT) intervention will focus on catastrophizing and rumination. CBT emphasizes the role of cognitive and behavioral factors on affective distress; The Cognitive-Behavioral Therapy (CBT) intervention will focus on catastrophizing and rumination. Behavioral factors on affective distress.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Treatment
Keywords: Psychological Therapy