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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00375167
Other study ID # 1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2006
Est. completion date May 2007

Study information

Verified date November 2018
Source Queen's University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The present study will determine if Spaniol and colleague's (1994) Recovery Workbook group intervention is an effective clinical tool to move a person with SMI along in their journey of recovery. The primary outcome measurements of this study will be the participants' perceived level of empowerment, hope and optimism, knowledge of recovery, and life satisfaction. This kind of information would add to the current body of knowledge about how principles of recovery can be used in psychoeducational programs used by outpatient community mental health services.


Description:

ABSTRACT:

Objective: Adopting the principles of recovery into the mental health field has been a growing area for discussion at many different levels of care. The present study will determine if Spaniol and colleague's (1994) Recovery Workbook group intervention can be used as an effective clinical tool to move a person with a severe mental illness along in their journey of recovery. The primary outcome measurements of this study will be the participants' perceived level of empowerment, hope and optimism, knowledge of recovery, and life satisfaction. Method: The study will be a multicenter, prospective, single-blinded, randomized control trial. Sixty participants will be recruited from three Assertive Community Treatment Teams (ACTT) in Kingston, Ontario and individuals will be randomized to either the control or intervention arm of the study. The control arm of the study will receive their regular services from ACTT. The intervention arm will participate in a 10-week psychoeducational group program in addition to receiving their regular services from ACTT. Results: Analysis will be performed by intention to treat, based on total scores of four assessments which will be performed at the trial commencement and termination.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date May 2007
Est. primary completion date January 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Receive support from an Assertive Community Treatment Team.

2. Meet the DSM-IV diagnostic classification for schizophrenia, schizoaffective, schizophreniform, delusional disorder, or bipolar disorder.

3. Aged 18-55 years-old.

4. Individuals agree to participate in the study after they have been informed of all the expected benefits and risks.

5. Neither substance misuse nor organic disorder judged to be the major cause of psychotic symptoms.

Exclusion Criteria:

1. Inability to give informed consent

2. Diagnosis of dementia

3. Significant head injury or other brain injury leading to cognitive impairment

4. Mental retardation (premorbid IQ < 65)

5. Require an interpreter

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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 services provided as per established and evidence-based fidelity standards.

Locations

Country Name City State
Canada Queen's University Kingston Ontario

Sponsors (1)

Lead Sponsor Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hope Herth Index 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. Within 3 days of completion of intervention
Primary Empowerment Scale 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). Within 3 days of completion of interventions
Primary Recovery Assessment Scale 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. Within 3 days of completion of intervention
Primary Quality of Life Index, General Version 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.. Within 3 days of completion of intervention
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