- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00375167
Efficacy of the Recovery Workbook as a Psychoeducational Tool for Facilitating Recovery
Efficacy of the Recovery Workbook as a Psychoeducational Tool for Facilitating Recovery in Persons With Severe and Persistent Mental Illness
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 3N6
- Queen's University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Receive support from an Assertive Community Treatment Team.
- Meet the DSM-IV diagnostic classification for schizophrenia, schizoaffective, schizophreniform, delusional disorder, or bipolar disorder.
- Aged 18-55 years-old.
- Individuals agree to participate in the study after they have been informed of all the expected benefits and risks.
- Neither substance misuse nor organic disorder judged to be the major cause of psychotic symptoms.
Exclusion Criteria:
- Inability to give informed consent
- Diagnosis of dementia
- Significant head injury or other brain injury leading to cognitive impairment
- Mental retardation (premorbid IQ < 65)
- Require an interpreter
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Recovery Workbook Intervention
12-week Recovery Intervention: The intervention is a 12-week group-based intervention.
The intervention is informed by the Recovery Workbook- a validated intervention for people with serious mental illness.
The intervention includes 2 hour sessions for 12 weeks that focus on the following areas: Introduction to the intervention; Recovery; Knowledge and Control; Managing life stress; Enhancing personal meaning; Building personal support; and Setting personal goals.
The total time period of the intervention is 24 hours.
Participants in this arm also receive treatment as usual.
|
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.
Assertive Community Treatment services provided as per established and evidence-based fidelity standards.
|
|
NO_INTERVENTION: Treatment as usual
The participants in the control arm will continue to receive treatment as usual.
TAU is Assertive Community Treatment.
Assertive Community Treatments are structured to meet set fidelity standards that are evidence-based.
This arm did not receive any intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hope Herth Index
Time Frame: 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.
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Within 3 days of completion of intervention
|
|
Empowerment Scale
Time Frame: 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).
|
Within 3 days of completion of interventions
|
|
Recovery Assessment Scale
Time Frame: 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.
|
Within 3 days of completion of intervention
|
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Quality of Life Index, General Version
Time Frame: 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..
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Within 3 days of completion of intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Skye Barbic, BScOT, Queen's University
- Principal Investigator: Terry Krupa, PhD, Queen's University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1 (Other Identifier: Mobile Health and Wellness Program)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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