Trial Outcomes & Findings for Dual Diagnosis Self-Help Referral (NCT NCT00286728)

Results Overview

Addiction Severity Index psychiatric composite ranges from 0 to 1, with 1 indicating more severe problems.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

287 participants

Primary outcome timeframe

6 months

Results posted on

2019-05-08

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 Intensive Referral Intensive referral to dual-focused self-help groups Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups	Arm 2 Usual Care Usual care
Overall Study STARTED	142	145
Overall Study COMPLETED	106	116
Overall Study NOT COMPLETED	36	29

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dual Diagnosis Self-Help Referral

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 Intensive Referral n=142 Participants Intensive referral to dual-focused self-help groups Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups	Arm 2 Usual Care n=145 Participants Usual care	Total n=287 Participants Total of all reporting groups
Age, Continuous	50.9 years STANDARD_DEVIATION 9.0 • n=99 Participants	51.2 years STANDARD_DEVIATION 8.8 • n=107 Participants	51.0 years STANDARD_DEVIATION 8.9 • n=206 Participants
Sex: Female, Male Female	11 Participants n=99 Participants	15 Participants n=107 Participants	26 Participants n=206 Participants
Sex: Female, Male Male	131 Participants n=99 Participants	130 Participants n=107 Participants	261 Participants n=206 Participants
Region of Enrollment United States	142 participants n=99 Participants	145 participants n=107 Participants	287 participants n=206 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Explanation of Ns discrepant with patient flow: Ns with psychiatric severity scores at 6 months differ from those having completed the study at 2 years.

Addiction Severity Index psychiatric composite ranges from 0 to 1, with 1 indicating more severe problems.

Outcome measures

Outcome measures
Measure	Arm 1 Intensive Referral n=101 Participants Intensive referral to dual-focused self-help groups Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups	Arm 2 Usual Care n=120 Participants Usual care
Psychiatric Functioning at 6 Months	.333 units on a scale Standard Deviation .199	.387 units on a scale Standard Deviation .228

SECONDARY outcome

Timeframe: 6 months, 1 year, 2 years

Population: Access to data is no longer available.

Outcome measures

Outcome data not reported

Adverse Events

Arm 1 Intensive Referral

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2 Usual Care

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 Intensive Referral n=142 participants at risk Intensive referral to dual-focused self-help groups Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups	Arm 2 Usual Care n=145 participants at risk Usual care
Social circumstances Died	1.4% 2/142	1.4% 2/145
Social circumstances Incarcerated	1.4% 2/142	2.1% 3/145

Other adverse events

Adverse event data not reported

Additional Information

Christine Timko

VAHSRD

Phone: 650-617-2746

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place