Clinical trial NCT00930293
Conditions: Depression Anxiety
Keywords: Interpersonal Psychotherapy
Sponsor: University of Pittsburgh
Start date: 2009-07-01; Completion date: 2012-06-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the feasibility and efficacy of a personalized psychotherapy treatment for people with depression and co-occurring anxiety.

Detailed description:
Approximately one half of all depressed psychiatric patients also meet the criteria for an anxiety disorder. Compared to people with only depression, people with both depression and panic features experience poorer psychological and social functioning, a greater risk of suicide, less response to medication and therapy treatment, and a greater risk of recurring symptoms. Because people with depression and co-occurring anxiety features do not achieve full symptom remission with either medication or therapy alone, this study will use a treatment that combines the two. A commonly used type of depression medication called a selective serotonin reuptake inhibitor (SSRI) will be combined with a specialized therapy developed to address depression with co-occurring symptoms of panic, anxiety, and avoidance. This study will also test a computer-based method of assessing mood and anxiety symptom profiles and outcomes to determine whether participants find this method acceptable and clinicians find it useful.

Participation in this study will last 20 weeks, with follow-up visits occurring 4 and 8 months after starting. Participants will be randomly assigned to receive either an individualized therapy for depression and anxiety, called interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS), or a standard therapy for depression, called brief supportive psychotherapy (BSP). All participants will complete up to 16 therapy sessions and receive a standard SSRI treatment with the medication citalopram hydrobromide. During the IPT-PS treatment, a study therapist will examine regular computer updates of depression and anxiety scores for participants and talk to them about identifying and addressing life stressors that trigger symptoms. During the BSP treatment, a study therapist will encourage participants to arrive at their own solutions by emphasizing the participants' strengths and examining what has worked in the past.

Participants will complete assessments weekly during the 20 weeks of the study intervention and at 4- and 8-month follow-up visits. These assessments will include self-report questionnaires about symptoms, medication side effects, and treatment adherence; vital sign and weight measurements; and a clinical interview. Regular assessments of medication effectiveness and side effects will occur every 1 to 4 weeks. Starting at the second study visit, participants will also complete monthly computer-based questionnaires about depression and anxiety symptoms.

Arms: arm 1: Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication (citalopram) treatment. arm 2: Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication (citalopram) treatment.
Interventions: intervention 1: Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS) intervention 2: Brief Supportive Psychotherapy (BSP) intervention 3: Citalopram hydrobromide
Intervention descriptions: intervention 1: 16 weekly IPT-PS sessions, each lasting approximately 45 minutes intervention 2: 16 weekly BPS sessions, each lasting approximately 45 minutes intervention 3: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day

Protocol documents: