Trial Outcomes & Findings for Testing Resources: Manual and Webinar Guided Treatment vs. Manual Guided Treatment (NCT NCT01743092)

Results Overview

The questionnaire asks the client about their perceived stress. The Perceived Stress Scale (Cohen, S., Kamarck, T., and Mermelstein, R. (1983). A global measure of perceived stress. Journal of Health and Social Behavior, 24, 386-396. December 1983) is a scale developed to measure the degree to which situations in one's life are appraised as stressful. Psychological stress has been defined as the extent to which persons perceive (appraise) that their demands exceed their ability to cope. The PSS has become one of the most widely used psychological instruments for measuring nonspecific perceived stress. The scale has ten questions asking respondents to circle a number between 0 and 4. (0 the feelings and thoughts during the last month: 0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often. The range of possible score is from 0 to 40. Scores around 13 are considered average. Scores of 20 or higher are considered to be indicative of high stress levels.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

59 participants

Primary outcome timeframe

12 weeks

Results posted on

2016-04-01

Participant Flow

Participant milestones

Participant milestones
Measure	Tutorial Workbook Tutorial Workbook Group only receives a Tutorial Workbook Group Tutuorial workbook: A work book about their addiciton	Tutorial Workbook Group Plus Webinar Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource. Webinar: Some clients will receive a webinar as part of their treatment. Tutuorial workbook: A work book about their addiciton
Overall Study STARTED	33	26
Overall Study COMPLETED	19	11
Overall Study NOT COMPLETED	14	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Tutorial Workbook Tutorial Workbook Group only receives a Tutorial Workbook Group Tutuorial workbook: A work book about their addiciton	Tutorial Workbook Group Plus Webinar Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource. Webinar: Some clients will receive a webinar as part of their treatment. Tutuorial workbook: A work book about their addiciton
Overall Study Lost to Follow-up	14	15

Baseline Characteristics

Testing Resources: Manual and Webinar Guided Treatment vs. Manual Guided Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tutorial Workbook n=33 Participants Tutorial Workbook Group only receives a Tutorial Workbook Group Tutuorial workbook: A work book about their addiciton	Tutorial Workbook Group Plus Webinar n=26 Participants Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource. Webinar: Some clients will receive a webinar as part of their treatment. Tutuorial workbook: A work book about their addiciton	Total n=59 Participants Total of all reporting groups
Age, Continuous	51 years n=5 Participants	56 years n=7 Participants	53 years n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	26 Participants n=7 Participants	59 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized white / european	22 participants n=5 Participants	22 participants n=7 Participants	44 participants n=5 Participants
Race/Ethnicity, Customized other	11 participants n=5 Participants	4 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment Canada	33 participants n=5 Participants	26 participants n=7 Participants	59 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: The number of data points in this analysis equals the number who completed the study, minus 2. There were 2 missing data points in this analysis because two people did not complete the questionnaire.

The questionnaire asks the client about their perceived stress. The Perceived Stress Scale (Cohen, S., Kamarck, T., and Mermelstein, R. (1983). A global measure of perceived stress. Journal of Health and Social Behavior, 24, 386-396. December 1983) is a scale developed to measure the degree to which situations in one's life are appraised as stressful. Psychological stress has been defined as the extent to which persons perceive (appraise) that their demands exceed their ability to cope. The PSS has become one of the most widely used psychological instruments for measuring nonspecific perceived stress. The scale has ten questions asking respondents to circle a number between 0 and 4. (0 the feelings and thoughts during the last month: 0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often. The range of possible score is from 0 to 40. Scores around 13 are considered average. Scores of 20 or higher are considered to be indicative of high stress levels.

Outcome measures

Outcome measures
Measure	Tutorial Workbook n=17 Participants Tutorial Workbook Group only receives a Tutorial Workbook Group Tutuorial workbook: A work book about their addiciton	Tutorial Workbook Group Plus Webinar n=11 Participants Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource. Webinar: Some clients will receive a webinar as part of their treatment. Tutuorial workbook: A work book about their addiciton
Perceived Stress Scale	15.2 units on a scale Standard Deviation 7.9	14.5 units on a scale Standard Deviation 7.1

SECONDARY outcome

Timeframe: 12 weeks

Population: The number of data points in this analysis equals the number who completed the study.

The Depression, Anxiety and Stress Scale (DASS 21) is a 21 item self-report questionnaire developed by Lovibond, S.H. \& Lovibond, P.F. (1995, Manual for the Depression Anxiety Stress Scales, 2nd. Ed., Sydney: Psychology Foundation). The range of total scores for each subscale is from 0 to 21. Higher values represent a worse outcome. Depression Normal 0-4 Mild 5-6 Moderate 7-10 Severe 11-13 Extremely Severe 14+ Anxiety Normal 0-3 Mild 4-5 Moderate 6-7 Severe 8-9 Extremely Severe 10+ Stress Normal 0-7 Mild 8-9 Moderate 10-12 Severe 13-16 Extremely Severe 17+

Outcome measures

Outcome measures
Measure	Tutorial Workbook n=19 Participants Tutorial Workbook Group only receives a Tutorial Workbook Group Tutuorial workbook: A work book about their addiciton	Tutorial Workbook Group Plus Webinar n=11 Participants Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource. Webinar: Some clients will receive a webinar as part of their treatment. Tutuorial workbook: A work book about their addiciton
DASS Depression depression	4.3 units on a scale Standard Deviation 4.2	3.5 units on a scale Standard Deviation 6.2
DASS Depression anxiety	3.8 units on a scale Standard Deviation 4.9	2.4 units on a scale Standard Deviation 3.3
DASS Depression Stress	3.6 units on a scale Standard Deviation 4.0	5.7 units on a scale Standard Deviation 4.9

Adverse Events

Tutorial Workbook

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tutorial Workbook Group Plus Webinar

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nigel Turner, Ph.D.

Centre for Addiction and Mental Health

Phone: 416-535-8501

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place