Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
5963
Study information
Scientific title
Recovery Approaches in Mental Health: Evaluating the Whole Life Approach Manual (WLAM) for Therapy in Persons with Schizophrenia
Acronym
WLAM
Study hypothesis
The study is a non-randomised, repeated-measures, comparative study of the Whole Life Approach Manual (WLAM). Outcomes will be assessed using both quantitative measures of health and social outcome, and qualitative measures of user perceptions and experience. The principal aim is to evaluate the effectiveness of WLAM using pre-therapy to post-therapy change in the Social Adaptation Self Assessment Scale (SASS) score in persons with schizophrenia. A comparison with a non-intervention control group will also be made. Further aims are to assess the cost of delivering WLAM, to measure adherence to the therapy and to obtain qualitative data which will illuminate which ingredients in the therapy are most successful and how the therapy can be further developed.
Ethics approval
MREC approved (ref: 08/H0311/122)
Study design
Single centre non-randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: Mental Health Research Network; Subtopic: Schizophrenia; Disease: Schizophrenia
Intervention
The Whole Life Approach Manual for Therapy is a novel therapeutic approach. It is a 15-step, 48-week, program that supports greater well being, social adaptation, life satisfaction and independence. A comparison with a non-intervention group receiving treatment as usual will also be made.
Study entry: registration only.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Social Adaptation Self-evaluation Scale (SASS). This is a self-report scale of 21 items, measured at baseline, week 24, week 48, week 60 and week 72.
Secondary outcome measures
1. Adherence with the program: adherence will be recorded by the Whole Life therapist using a five-point scale
2. Hospital Anxiety and Depression Scale (HADS), measured at baseline, week 24, week 48, week 60 and week 72
3. Health of the Nation Outcome Scales, measured at baseline, week 24, week 48, week 60 and week 72
4. Participant's perception of therapy
5. Qualitative evaluation of Whole Life Therapy
6. Social and Occupational Functioning Assessment Scale, measured at baseline, week 24, week 48, week 60 and week 72
Overall trial start date
14/01/2009
Overall trial end date
30/09/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18 - 65 years at study recruitment visit (week 0), either sex
2. A current diagnosis of schizophrenia, schizoaffective disorder, delusional disorder or schizophreniform disorder within the meaning of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), confirmed either by the treating clinician or case record examination by a research psychiatrist
3. Current impairment in social, personal and occupational function as defined by the presence of both of a score of 35 on the SASS and a score of 75 on the Social and Occupational Functioning Assessment Scale (SOFAS)
4. Currently taking antipsychotic pharmacotherapy and with a clinical evaluation that at least 50% compliance can reasonably be expected in the forthcoming one-year period. This would typically be taken to mean that the intended dose is taken fully on 50% of days or that the full intended dose is taken on 50% of days or permutations falling between these limits.
5. Considered clinically stable by the treating psychiatrist
6. WLAM therapy is judged an appropriate therapeutic intervention by the treating psychiatrist
7. Able to give informed consent
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Planned sample size: 120; UK sample size: 120
Participant exclusion criteria
1. Within 180 days of the first date of diagnosis. Date of diagnosis will be taken to be the date of first diagnosis by a clinician.
2. Inpatient psychiatric attention for greater than 7 days, with any of those days being within 30 days of study entry (recruitment visit, week 0)
3. Presence of an affective psychosis which, in the opinion of the treating psychiatrist, dominates the clinical picture
4. Currently severely depressed, as defined by a score of greater than 14 on the depression subscale of the Hospital Anxiety and Depression Scale (HAD)
5. Meets DSM-IV syndromal criteria for borderline personality disorder. Potential participants with borderline personality features not meeting full criteria may be included provided that the treating psychiatrist is of the opinion that there is not syndromal borderline personality disorder.
6. Previously received WLAM for greater than 30 days
7. Received specialist therapeutic attention for a substance dependence disorder in the past 6 months. The use of illicit substances is not, in itself, exclusionary.
8. Currently subject to any legal limitation or restriction on freedom (e.g. subject to court order, probation or the Mental Health Act)
9. Currently taking exceptionally high doses of antipsychotic pharmacotherapy meaning: a total dose exceeding an aggregated 170% of BNF upper limit dosing for one or more antipsychotic drugs singly or combined, e.g., two antipsychotic drugs both being taken at 90% of their respective BNF maxima would be exclusionary
10. Currently receiving a structured psychotherapy that would continue concomitantly with WLAM therapy. Structured psychotherapy will be taken to include cognitive-behavioural therapy, interpersonal therapy, cognitive-analytic therapy, psychodynamic therapy. Therapies such as anxiety management, assertiveness training and social therapies will not be regarded as exclusionary.
11. Would be unable to undertake any free market employment because of physical disabilities directly attributable to a physical disease or handicap and that disease or handicap is permanent and irremediable
Recruitment start date
14/01/2009
Recruitment end date
30/09/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
College Lane
Hatfield
AL10 9AB
United Kingdom
Sponsor information
Organisation
Hertfordshire Partnership Foundation NHS Trust (UK)
Sponsor details
Hertfordshire Partnership Foundation NHS Trust
99 Waverley Road
St. Albans
AL3 5TL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary