Trial Outcomes & Findings for Intervention for Veterans With Depression, Substance Disorder, and Trauma (NCT NCT00958217)

Last Updated: 2016-03-24

Results Overview

Depression symptoms were assessed using a structured clinical interview assessment consisting of 21 items. Depression symptoms experienced in the past week are rated on a 0 (none) to 4 (most severe) scale. The total score is summed from the item scores and range from 0 (none) to 84 (most severe). We tested whether treatment group interacted with time in order to examine whether trajectories of symptom scores differed across treatment conditions. Linear mixed effects models were used to ascertain trajectories of total scores from randomization through end of study (6 timepoints across approximately 15 months). This analytic approach was advantageous in that it provided examination of change in depression across all quarterly assessments. Models were estimated with maximum likelihood methods. Total score at the time of randomization is reported in Data Table and coefficient estimates for trajectories are reported in Statistical Analysis.

Recruitment status

COMPLETED

Study phase

Target enrollment

154 participants

Primary outcome timeframe

Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months)

Results posted on

2016-03-24

Participant Flow

Veterans referred to a VA dual diagnosis outpatient clinic who were diagnosed with depressive disorder, substance use disorder, and had a history of trauma (with and without a posttraumatic stress disorder diagnosis) were recruited from December 2009 through October 2012.

All participants engaged in 12 weeks of group Integrated Cognitive Behavioral Therapy and were then randomized to the individual study interventions. 31 participants were not randomized (3 died, 6 moved, 6 withdrew, 4 lost, 4 not stable, 4 did not meet study criteria, 4 sober living facility did not allow).

Participant milestones

Participant milestones
Measure	Arm 1: Cognitive Processing Therapy- Modified Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions. CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills.	Arm 2: Integrated Cognitive Behavioral Therapy Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions. ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse
Overall Study STARTED	61	62
Overall Study End of Treatment	56	57
Overall Study COMPLETED	37	37
Overall Study NOT COMPLETED	24	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: Cognitive Processing Therapy- Modified Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions. CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills.	Arm 2: Integrated Cognitive Behavioral Therapy Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions. ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse
Overall Study Death	2	1
Overall Study Withdrawal by Subject	4	3
Overall Study Lost to Follow-up	17	19
Overall Study Moved out of area	1	1
Overall Study Inpatient hospitalization	0	1

Baseline Characteristics

Intervention for Veterans With Depression, Substance Disorder, and Trauma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: CPT-M n=61 Participants Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) were recruited. CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills.	Arm 2: ICBT n=62 Participants Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) were recruited. ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse	Total n=123 Participants Total of all reporting groups
Age, Continuous	47.2 years STANDARD_DEVIATION 12.1 • n=5 Participants	47.3 years STANDARD_DEVIATION 11.9 • n=7 Participants	47.3 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	54 Participants n=7 Participants	109 Participants n=5 Participants
PTSD Current diagnosis with PTSD diagnosis	51 participants n=5 Participants	50 participants n=7 Participants	101 participants n=5 Participants
PTSD Current diagnosis without PTSD diagnosis	10 participants n=5 Participants	12 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months)

Outcome measures

Outcome measures
Measure	Arm 1: Cognitive Processing Therapy- Modified n=61 Participants Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions. CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills.	Arm 2: Integrated Cognitive Behavioral Therapy n=62 Participants Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions. ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse
Depression Symptoms Were Assessed With the Hamilton Depression Rating Scale.	31.92 units on a scale Standard Deviation 12.37	28.85 units on a scale Standard Deviation 12.25

PRIMARY outcome

Timeframe: Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months)

The Posttraumatic Stress Disorder Checklist - Civilian version (PCL-C) is a 17 item self-report checklist of PTSD symptoms experienced in the past month rated on a 1 (not at all) to 5 (extremely) scale; total score is summed from the item scores and range from 17 (none) to 85 (most severe). . Civilian version was selected as it allows for a variety of trauma types. Scores above 50 are considered clinical levels. We tested whether treatment group interacted with time to examine whether trajectories of symptom scores differed across treatment conditions. Linear mixed effects models were used to ascertain trajectories of total scores. This analytic approach was advantageous in that it provided examination of change in PTSD across all quarterly assessments. Models were estimated with maximum likelihood methods. Total score at the time of randomization is reported in Data Table and coefficient estimates for trajectories are reported in Statistical Analysis.

Outcome measures

Outcome measures
Measure	Arm 1: Cognitive Processing Therapy- Modified n=61 Participants Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions. CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills.	Arm 2: Integrated Cognitive Behavioral Therapy n=62 Participants Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions. ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse
Posttraumatic Stress Disorder (PTSD) Symptoms	58.4 units on a scale Standard Deviation 12.4	55.5 units on a scale Standard Deviation 14.2

PRIMARY outcome

Timeframe: Assessed quarterly; trajectories analyzed from randomization through end of study (covering approximately 15 months)

The Timeline Followback is a calendar-assisted structured interview that assesses the frequency of alcohol and drug use on a daily basis and the quantity of alcohol use. Summary proportion of days abstinent were calculated at each time point. Trajectory analyses examine two substance use outcomes: probability of any alcohol or drug use on a given day and probability of heavy drinking (5 or more drinks consumed in a day) on a given day. Trajectories of substance use (any alcohol or drug use on a particular day) and heavy drinking (\>5 drinks on a particular day) were modeled as dichotomous outcomes, using logit links to predict the probability of substance use or heavy drinking on a particular day. Data Table reports starting proportion of days abstinent at time of randomization.

Outcome measures

Outcome measures
Measure	Arm 1: Cognitive Processing Therapy- Modified n=61 Participants Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions. CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills.	Arm 2: Integrated Cognitive Behavioral Therapy n=62 Participants Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions. ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse
Timeline Followback	.84 proportion of days abstinent Standard Deviation .26	.81 proportion of days abstinent Standard Deviation .30

Adverse Events

Arm 1: Cognitive Processing Therapy- Modified

Serious events: 15 serious events

Other events: 25 other events

Deaths: 0 deaths

Arm 2: Integrated Cognitive Behavioral Therapy

Serious events: 19 serious events

Other events: 55 other events

Deaths: 0 deaths

ICBT Prior to Randomization

Serious events: 10 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1: Cognitive Processing Therapy- Modified n=61 participants at risk Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions. CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills.	Arm 2: Integrated Cognitive Behavioral Therapy n=62 participants at risk Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions. ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse	ICBT Prior to Randomization n=20 participants at risk；n=23 participants at risk All participants attended 12 weeks of group Integrated Cognitive Behavioral Therapy prior to randomization to provide for a period of stabilization and to develop relapse prevention and mood management skills. This portion will report on only those participants who were not randomized to individual CPT-M or ICBT.
Gastrointestinal disorders Medical inpatient admission - alcohol related	1.6% 1/61 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	3.2% 2/62 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	4.3% 1/23 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.
Infections and infestations Medical inpatient admission - infection	1.6% 1/61 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	4.8% 3/62 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	0.00% 0/23 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.
Psychiatric disorders Inpatient psychiatric admission for suicidal ideation/behaviors	9.8% 6/61 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	16.1% 10/62 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	13.0% 3/23 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.
Psychiatric disorders Inpatient admission for alcohol/drug treatment	6.6% 4/61 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	1.6% 1/62 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	4.3% 1/23 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.
General disorders Death - unknown cause	1.6% 1/61 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	0.00% 0/62 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	13.0% 3/23 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.
Hepatobiliary disorders Death - liver disease	1.6% 1/61 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	0.00% 0/62 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	0.00% 0/23 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.
Injury, poisoning and procedural complications Death - hit by motor vehicle	0.00% 0/61 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	1.6% 1/62 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	0.00% 0/23 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.
Psychiatric disorders Suicidal behavior under the influence	0.00% 0/61 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	1.6% 1/62 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	0.00% 0/23 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.
Gastrointestinal disorders Medical inpatient admission - surgery	0.00% 0/61 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	0.00% 0/62 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	4.3% 1/23 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.
Injury, poisoning and procedural complications Medical inpatient admission - assault injuries	1.6% 1/61 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	0.00% 0/62 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	0.00% 0/23 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.
Psychiatric disorders Disappearance	0.00% 0/61 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	1.6% 1/62 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	0.00% 0/23 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.
Psychiatric disorders Emergency Dept visit - intoxication	0.00% 0/61 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	0.00% 0/62 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	4.3% 1/23 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.

Other adverse events

Other adverse events
Measure	Arm 1: Cognitive Processing Therapy- Modified n=61 participants at risk Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions. CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills.	Arm 2: Integrated Cognitive Behavioral Therapy n=62 participants at risk Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions. ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse	ICBT Prior to Randomization n=20 participants at risk；n=23 participants at risk All participants attended 12 weeks of group Integrated Cognitive Behavioral Therapy prior to randomization to provide for a period of stabilization and to develop relapse prevention and mood management skills. This portion will report on only those participants who were not randomized to individual CPT-M or ICBT.
Psychiatric disorders Arrest/jail/legal	9.8% 6/61 • Number of events 6 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	16.1% 10/62 • Number of events 10 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	5.0% 1/20 • Number of events 1 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.
General disorders Outpatient surgery	1.6% 1/61 • Number of events 1 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	16.1% 10/62 • Number of events 10 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	0.00% 0/20 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.
General disorders Urgent Care, Medical	24.6% 15/61 • Number of events 15 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	51.6% 32/62 • Number of events 32 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	0.00% 0/20 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.
Psychiatric disorders Urgent Care, Psychiatric	4.9% 3/61 • Number of events 3 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	4.8% 3/62 • Number of events 3 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.	0.00% 0/20 • 4 years Number at Risk for Serious Adverse Events in the ICBT Prior to Randomization Arm is 23, excluding 4 participants who were lost and 4 participants who did not meet study criteria; we have no data and Adverse Events were not collected for these 8. For Other Adverse Events, we excluded 3 participants who died and not at risk for events.

Additional Information

Susan R. Tate, Ph.D., Clinical Psychologist

VA San Diego Healthcare System/UCSD

Phone: 619-426-9402

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place