Trial Outcomes & Findings for Efficacy of the Recovery Workbook as a Psychoeducational Tool for Facilitating Recovery (NCT NCT00375167)

Results Overview

The Herth Hope Index was used to gather information about participants' level of hopefulness. The 12-item scale is easily administered and has been used with persons with serious mental illness . It is a self-report tool, and respondents answer on a 4-point agreement scale that ranges from "strongly disagree" to "strongly agree". The scoring range is from 12-48 with a higher score indicating higher levels of hope. The scale has been shown to have an alpha coefficient of .97 and a test-retest reliability of .91 within two weeks. Criterion-related validity has also been supported by high correlations (.81-.92) with instruments measuring the same construct.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

Within 3 days of completion of intervention

Results posted on

2019-03-06

Participant Flow

Managers of 2 ACT teams reviewed all clients to identify those eligible for study between August and October 2006. Eighty-one identified and informed about the study, with 34 people providing informed consent. Clients were grouped by team and then randomized to one of the two arms. One person dropped out at time of randomization

Participants were grouped according to team prior to randomization because the group intervention was administered by team

Participant milestones

Participant milestones
Measure	ACT With Recovery Workbook Recovery Workbook (Psychoeducation training) Clients of Assertive Community Treatment randomized to condition receiving the Recovery Workbook intervention in a group format over 12 weeks. The sessions focus on the following areas: Introduction; Recovery; Knowledge and Control; Managing life stress; Enhancing personal meaning; Building personal support and; Setting personal goals Recovery Workbook Training (psychoeducational training): The Recovery Workbook uses an educational process to increase awareness of recovery, increase knowledge and control of the illness, increase awareness of the importance and nature of stress, enhance personal meaning, build personal support, and develop goals and plans of action. The intervention period of 30 weekly sessions recommended by Spaniol and colleagues was shortened to 12 weekly sessions to accommodate for clinical and participant commitment. No workbook content was excluded, and all practice exercises were covered.	ACT as Usual Assertive community Treatment The participants were clients of Assertive Community Treatment receiving standard treatment as usual. Assertive Community Treatments are structured to meet set fidelity standards that are evidence-based. ACT as usual: Assertive Community Treatment services provided as per established and evidence-based fidelity standards.
Overall Study STARTED	16	17
Overall Study COMPLETED	16	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of the Recovery Workbook as a Psychoeducational Tool for Facilitating Recovery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ACT With Recovery Workbook n=16 Participants Recovery Workbook (Psychoeducation training) Clients of Assertive Community Treatment randomized to condition receiving the Recovery Workbook intervention in a group format over 12 weeks. The sessions focus on the following areas: Introduction; Recovery; Knowledge and Control; Managing life stress; Enhancing personal meaning; Building personal support and; Setting personal goals Recovery Workbook Training (psychoeducational training): The Recovery Workbook uses an educational process to increase awareness of recovery, increase knowledge and control of the illness, increase awareness of the importance and nature of stress, enhance personal meaning, build personal support, and develop goals and plans of action. The intervention period of 30 weekly sessions recommended by Spaniol and colleagues was shortened to 12 weekly sessions to accommodate for clinical and participant commitment. No workbook content was excluded, and all practice exercises were covered.	ACT as Usual n=17 Participants Assertive community Treatment The participants were clients of Assertive Community Treatment receiving standard treatment as usual. Assertive Community Treatments are structured to meet set fidelity standards that are evidence-based. ACT as usual: Assertive Community Treatment services provided as per established and evidence-based fidelity standards.	Total n=33 Participants Total of all reporting groups
Age, Continuous Age	44.69 years STANDARD_DEVIATION 9.62 • n=5 Participants	44.58 years STANDARD_DEVIATION 8.05 • n=7 Participants	44.62 years STANDARD_DEVIATION 8.50 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Hope, Empowerment, Recovery, QOL Hope	37.13 units on a scale STANDARD_DEVIATION 6.53 • n=5 Participants	36.00 units on a scale STANDARD_DEVIATION 5.36 • n=7 Participants	36.54 units on a scale STANDARD_DEVIATION 5.38 • n=5 Participants
Hope, Empowerment, Recovery, QOL Empowermeent	61.96 units on a scale STANDARD_DEVIATION 6.91 • n=5 Participants	63.88 units on a scale STANDARD_DEVIATION 6.91 • n=7 Participants	62.95 units on a scale STANDARD_DEVIATION 6.87 • n=5 Participants
Hope, Empowerment, Recovery, QOL Quality of Life	20.34 units on a scale STANDARD_DEVIATION 5.01 • n=5 Participants	20.70 units on a scale STANDARD_DEVIATION 4.13 • n=7 Participants	20.53 units on a scale STANDARD_DEVIATION 4.51 • n=5 Participants
Hope, Empowerment, Recovery, QOL Recovery	163.75 units on a scale STANDARD_DEVIATION 22.60 • n=5 Participants	156.41 units on a scale STANDARD_DEVIATION 14.22 • n=7 Participants	159.97 units on a scale STANDARD_DEVIATION 18.87 • n=5 Participants

PRIMARY outcome

Timeframe: Within 3 days of completion of intervention

The Herth Hope Index was used to gather information about participants' level of hopefulness. The 12-item scale is easily administered and has been used with persons with serious mental illness . It is a self-report tool, and respondents answer on a 4-point agreement scale that ranges from "strongly disagree" to "strongly agree". The scoring range is from 12-48 with a higher score indicating higher levels of hope. The scale has been shown to have an alpha coefficient of .97 and a test-retest reliability of .91 within two weeks. Criterion-related validity has also been supported by high correlations (.81-.92) with instruments measuring the same construct.

Outcome measures

Outcome measures
Measure	ACT With Recovery Workbook n=16 Participants Recovery Workbook These participants were clients of Assertive Community Treatment who were randomized to condition where in addition to usual service they received the Recovery Workbook intervention in a group format over 12 weeks. The sessions focus on the following areas: Introduction; Recovery; Knowledge and Control; Managing life stress; Enhancing personal meaning; Building personal support and; Setting personal goals Recovery Workbook Training:The Recovery Workbook uses an educational process to increase awareness of recovery, increase knowledge and control of the illness, increase awareness of the importance and nature of stress, enhance personal meaning, build personal support, and develop goals and plans of action. The intervention period of 30 weekly sessions recommended by Spaniol and colleagues was shortened to 12 weekly sessions to accommodate for clinical and participant commitment. No workbook content was excluded, and all practice exercises were covered.	ACT as Usual n=17 Participants Assertive community Treatment The participants were clients of Assertive Community Treatment receiving standard treatment as usual. Assertive Community Treatments are structured to meet set fidelity standards that are evidence-based. ACT as usual: Assertive Community Treatment services provided as per established and evidence-based fidelity standards.
Hope Herth Index	38.93 units on a scale Standard Deviation 5.34	35.06 units on a scale Standard Deviation 5.36

PRIMARY outcome

Timeframe: Within 3 days of completion of interventions

The construct measured is empowerment. The Empowerment Scale is a self-reported measure that contains 28 statements about empowerment to which participants respond on a 4-point agreement scale. Scoring range is 28-112, with a lower score indicating higher empowerment. Studies have demonstrated the scale's high internal consistency ({alpha}=.85-.90) and good reliability ({alpha}\>.60) and validity (28,31,32).

Outcome measures

Outcome measures
Measure	ACT With Recovery Workbook n=16 Participants Recovery Workbook These participants were clients of Assertive Community Treatment who were randomized to condition where in addition to usual service they received the Recovery Workbook intervention in a group format over 12 weeks. The sessions focus on the following areas: Introduction; Recovery; Knowledge and Control; Managing life stress; Enhancing personal meaning; Building personal support and; Setting personal goals Recovery Workbook Training:The Recovery Workbook uses an educational process to increase awareness of recovery, increase knowledge and control of the illness, increase awareness of the importance and nature of stress, enhance personal meaning, build personal support, and develop goals and plans of action. The intervention period of 30 weekly sessions recommended by Spaniol and colleagues was shortened to 12 weekly sessions to accommodate for clinical and participant commitment. No workbook content was excluded, and all practice exercises were covered.	ACT as Usual n=17 Participants Assertive community Treatment The participants were clients of Assertive Community Treatment receiving standard treatment as usual. Assertive Community Treatments are structured to meet set fidelity standards that are evidence-based. ACT as usual: Assertive Community Treatment services provided as per established and evidence-based fidelity standards.
Empowerment Scale	55.93 units on a scale Standard Deviation 6.91	61.96 units on a scale Standard Deviation 7.33

PRIMARY outcome

Timeframe: Within 3 days of completion of intervention

The construct is Personal Recovery, defined as a person's ability to live a full and meaningful life. The Recovery Assessment Scale (RAS) has 41-items and uses a 5-point agreement scale, and a total score is used, with scores ranging from 41-205, with a higher score indicating a higher sense of personal recovery. The RAS also has 5 subscales (see below). Subscales are added to produce a total score. Domain 1 is Confidence and Hope. he scoring range here is 9-45, where a higher score indicating higher recovery. Domain 2 is Willingness to Ask for Help. Scoring range is 3-15. Domain 3: Ability rely on others: Scoring range 5-25. Domain 4 Symptoms: Scoring range 4-20. Domain 5: Goal and Success Orientation: Scoring range 3-15. For each domain, higher values represent a better outcome.

Outcome measures

Outcome measures
Measure	ACT With Recovery Workbook n=16 Participants Recovery Workbook These participants were clients of Assertive Community Treatment who were randomized to condition where in addition to usual service they received the Recovery Workbook intervention in a group format over 12 weeks. The sessions focus on the following areas: Introduction; Recovery; Knowledge and Control; Managing life stress; Enhancing personal meaning; Building personal support and; Setting personal goals Recovery Workbook Training:The Recovery Workbook uses an educational process to increase awareness of recovery, increase knowledge and control of the illness, increase awareness of the importance and nature of stress, enhance personal meaning, build personal support, and develop goals and plans of action. The intervention period of 30 weekly sessions recommended by Spaniol and colleagues was shortened to 12 weekly sessions to accommodate for clinical and participant commitment. No workbook content was excluded, and all practice exercises were covered.	ACT as Usual n=17 Participants Assertive community Treatment The participants were clients of Assertive Community Treatment receiving standard treatment as usual. Assertive Community Treatments are structured to meet set fidelity standards that are evidence-based. ACT as usual: Assertive Community Treatment services provided as per established and evidence-based fidelity standards.
Recovery Assessment Scale Recovery total	168.81 units on a scale Standard Deviation 20.11	149.11 units on a scale Standard Deviation 22.09
Recovery Assessment Scale Confidence and Hope	37.13 units on a scale Standard Deviation 5.51	31.82 units on a scale Standard Deviation 7.92
Recovery Assessment Scale Willingness to Ask for Help	12.00 units on a scale Standard Deviation 2.33	11.11 units on a scale Standard Deviation 1.73
Recovery Assessment Scale Ability rely on others	21.31 units on a scale Standard Deviation 2.91	18.35 units on a scale Standard Deviation 4.74
Recovery Assessment Scale Symptoms	17.18 units on a scale Standard Deviation 1.79	14.76 units on a scale Standard Deviation 2.61
Recovery Assessment Scale Goal and Success Orientation	11.75 units on a scale Standard Deviation 2.11	9.65 units on a scale Standard Deviation 2.62

PRIMARY outcome

Timeframe: Within 3 days of completion of intervention

The Quality of Life Index, General Version (37), is a 33-item self-report scale measuring satisfaction with and importance of aspects of life. It includes four subscales: health and functioning, socioeconomic status, psychological status, and significant others. Satisfaction and importance are measured on a 6-point agreement scale. A high score indicates higher quality of life. Full scoring instructions and computer algorithm is available at http://qli.org.uic.edu/questionaires/pdf/genericversionIII/genericscoring.pdf. Importance ratings are used to weight satisfaction responses so that scores reflect satisfaction with aspects of life that are valued by the individual (37). For internal consistency and reliability, Cronbach's alpha is .92 for the entire tool and .88, .75, .80, and .68, respectively, for the subscales (37). Possible range for the final scores = 0 to 30, where a higher value represents a better outcome..

Outcome measures

Outcome measures
Measure	ACT With Recovery Workbook n=16 Participants Recovery Workbook These participants were clients of Assertive Community Treatment who were randomized to condition where in addition to usual service they received the Recovery Workbook intervention in a group format over 12 weeks. The sessions focus on the following areas: Introduction; Recovery; Knowledge and Control; Managing life stress; Enhancing personal meaning; Building personal support and; Setting personal goals Recovery Workbook Training:The Recovery Workbook uses an educational process to increase awareness of recovery, increase knowledge and control of the illness, increase awareness of the importance and nature of stress, enhance personal meaning, build personal support, and develop goals and plans of action. The intervention period of 30 weekly sessions recommended by Spaniol and colleagues was shortened to 12 weekly sessions to accommodate for clinical and participant commitment. No workbook content was excluded, and all practice exercises were covered.	ACT as Usual n=17 Participants Assertive community Treatment The participants were clients of Assertive Community Treatment receiving standard treatment as usual. Assertive Community Treatments are structured to meet set fidelity standards that are evidence-based. ACT as usual: Assertive Community Treatment services provided as per established and evidence-based fidelity standards.
Quality of Life Index, General Version	20.34 units on a scale Standard Deviation 5.01	20.70 units on a scale Standard Deviation 4.13

Adverse Events

ACT With Recovery Workbook

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ACT as Usual

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

Dr. Terry Krupa

Queens University

Phone: 613-533-6236

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place