NCT00375167

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
11.9 years until next milestone

Results Posted

Study results publicly available

March 6, 2019

Completed
Last Updated

March 6, 2019

Status Verified

November 1, 2018

Enrollment Period

4 months

First QC Date

September 11, 2006

Results QC Date

October 26, 2015

Last Update Submit

November 7, 2018

Conditions

Keywords

Recovery, Hope, Empowerment, Randomized Control Trial

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Recovery Workbook Intervention

EXPERIMENTAL

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.

Behavioral: Recovery Workbook Training (psychoeducational training)Behavioral: ACT as usual

Treatment as usual

NO INTERVENTION

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.

Interventions

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.

Recovery Workbook Intervention
ACT as usualBEHAVIORAL

Assertive Community Treatment services provided as per established and evidence-based fidelity standards.

Recovery Workbook Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

MeSH Terms

Conditions

Mental DisordersEmpowerment

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Results Point of Contact

Title
Dr. Terry Krupa
Organization
Queens University

Study Officials

  • Skye Barbic, BScOT

    Queen's University

    PRINCIPAL INVESTIGATOR
  • Terry Krupa, PhD

    Queen's University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 11, 2006

First Posted

September 12, 2006

Study Start

September 1, 2006

Primary Completion

January 1, 2007

Study Completion

May 1, 2007

Last Updated

March 6, 2019

Results First Posted

March 6, 2019

Record last verified: 2018-11

Locations