Brief Culturally Adapted Cognitive Behavior Therapy for Psychosis
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      While Cognitive behavior therapy for psychosis (CBTp) is now established as an effective and
      evidence based therapy for psychotic illnesses in the west and is recommended by the national
      organizations both in Europe and in the USA. However, CBT remains limited to the western
      clients. We have adapted CBT for psychosis in Pakistan for use with local clients. Initial
      evaluations have found that these therapies are effective. Due to the financial restraints we
      would like to test a brief version of the Culturally adapted CBTp (CaCBTp) in Pakistan. We
      want to see if brief CaCBTp (6 sessions of CBT) would be effective in non western cultures in
      educing symptoms of schizophrenia. This study will test brief CaCBTp against care as usual in
      Pakistan in secondary care.
    

Detailed description: 
      BACKGROUND A number of systematic reviews and meta-analyses (for example, Wykes, Steel,
      Everitt, & Tarrier, 2008) have concluded that Cognitive Behaviour Therapy (CBT) is effective
      in treating people with schizophrenia. Most of this work was however, conducted in the West.
      In a literature search no study of CBT for psychosis in English language literature was found
      from a low or middle income country, including from Pakistan. Only two studies of
      psychological interventions for schizophrenia were found from Pakistan (Farooq et al., 2011;
      Nasr, Kausar, & others, 2009).

      It has been suggested that cultural differences can influence the process of Cognitive
      Behaviour Psychotherapy, and therefore therapy might need adapting to the cultural needs of a
      given country. Our group has adapted Cognitive Therapy for depression in Pakistan (F. Naeem,
      Ayub, Gobbi, & Kingdon, 2009; F. Naeem, Gobbi, Ayub, Kingdon, & others, 2010; Farooq Naeem,
      Ayub, Kingdon, & Gobbi, 2012; Farooq Naeem, Gobbi, Ayub, & Kingdon, 2009) , which was found
      to be effective in a small trial (Farooq Naeem, Waheed, Gobbi, Ayub, & Kingdon, 2011). Same
      methodology was useed to adapt CBT for schizophrenia for local use (Naeem et al, under
      review). A small pilot found it to be effective in inpatient settings. (Habib et al, under
      review). This is a RCT to test the effectiveness of Culturally adapted CBT for psychosis
      (CaCBTp).

      METHODS Aims The aim of this RCT is to test brief culturally adapted Cognitive Therapy for
      Schizophrenia against Treatment As Usual in Pakistan.

      Study area and population:

      Study participants will be recruited mainly from hospitals in Lahore/Karachi, Pakistan.

      Sample Inclusion criteria include;

        -  living within travelling distance of the hospital

        -  and with a diagnosis of Schizophrenia according to ICD10, RDC

        -  age between 18 to 65 years

        -  and at least 5 years of education/ or the main carer with at least 5 years of education.
           The exclusion criteria include;

        -  co-morbid alcohol or substance dependence

        -  organic brain syndrome or learning disability

        -  and high levels of disturbed behavior/or high risk of suicide or homicide.

      Sample size The sample size was calculated on showing a difference in the post-treatment
      PANSS positive symptoms score between groups. A previous study (reference in here?) found a
      standard deviation for the post-treatment scores of 5.8 in the control group, and 1.8 in the
      CBT group. In the analysis, the pre-treatment scores will be adjusted for, and the previous
      study found a correlation of 0.2 between the pre and post treatment scores. A difference
      between groups of 15% of the pre-treatment values would be regarded as being of clinical
      importance. This equates to a difference of 3 units on the PANNS positive symptoms score
      scale. Using a 5% significance level and 90% power, it is calculated that 41 subjects per
      group are required, 82 in total. It is expected that up to 30% of patients may drop-out of
      the study. To allow for this, a total of 120 patients will be recruited into the study.

      Procedure Mental health professional from the hospitals will be contacted and the purpose of
      the study will be explained to them. Patients referred by them received information about the
      study. After taking informed consent participants will be assessed by blind assessors who
      will be psychology graduates and had received one day training in using assessment tools.
      After completion of the assessment, participants will be randomly assigned to either CBT or
      Treatment As Usual group. Randomization will be performed using randomization.com.

      Ethical approval The Ethics Committee of Pakistan Association of Cognitive Therapists (PACT)
      has granted ethical approval for this study.

      Measures Data regarding demographic characteristics will be collected using a data collection
      form. Psychopathology will be measured using the PANSS (Positive and Negative Syndrome Scale
      of Schizophrenia), PSYRATS (Psychotic Symptom Rating Scales), and the Insight Scale. The
      above scales were translated into Urdu using standard methodology(Ahmer, Faruqui, & Aijaz,
      2007). Positive and Negative Syndrome Scale of Schizophrenia (PANSS) (Kay, Flszbein, & Opfer,
      1987) is a widely used, well established and comprehensive symptom rating scale measuring
      mental state. It has 30 items, each measured on a seven point rating instrument. There are
      three sub-scales (Positive Symptoms, Negative Symptoms and General Psychopathology) along
      with a total score. The test re test reliability of PANSS is 0.88 and Criterion related
      validity is 0.62. The Structured Clinical Interview for PANSS (SCI-PANSS) (Kay, 1991) was
      used in this study.

      Psychotic Symptom Rating Scales (PSYRATS) (Gillian Haddock, McCarron, Tarrier, & Faragher,
      1999) is a 17 item interviewer scored instrument which consist of 2 subscales (PSYRATS Voice,
      PSYRAT Delusion) which measures the severity of a number of dimensions of auditory
      hallucinations and delusions including the amount and intensity of distress associated with
      these symptoms. The 11 item hallucination sub-scale consists of items such as frequency,
      duration, loudness, negative content, intensity of distress and degree of disruption. The six
      item delusion sub-scale (PSYRATS delusion) consists of items such as amount of
      pre-occupation, degree of conviction, intensity of distress and disruption. All items are
      rated on a five point scale of increasing severity (0 = No problem to 4 = Maximum severity).
      The PSYRATS has demonstrated good inter rater reliability (intra class correlation (ICCS) for
      most item > .90), test re test reliability (ICCS for both subscales = .70), concurrent
      validity, and sensitivity to change in patients diagnosed with Schizophrenia.

      Insight will be rated using the Schedule for Assessment of Insight (SAI) (David, Buchanan,
      Reed, & Almeida, 1992). The SAI rates three dimensions of insight; Treatment Adherence
      (SAI-TA), Recognition of Illness (SAI-RI) and Symptom Relabelling (SAI-SR). Symptom
      Relabelling involves the recognition of a psychotic symptom and the understanding that it is
      a pathological event. Each dimension comprises two or three questions which are scored on a
      3-point scale from 0 (no insight) to 2 (good insight), with a maximum total score of 24. The
      sub-scale totals are summed for a total insight score.

      Brief disability rating questionnaire will be used to measure change in level of disability.

      Intervention The CBT intervention will consist of 6 session sessions lasting approximately
      one hour. There will be one additional session for the family. It has been observed that
      family members are involved actively in patient care in Pakistan, so the main carer/family
      member will be involved in the treatment plan from the beginning. A key carer will be
      identified with whom researcher will work in close collaboration. This person helped with
      homework if required. The sessions will be planned according to a manualized treatment
      protocol (Kingdon & Turkington, 1994). Therapy will be delivered using guidelines developed
      for cultural adaptation in Pakistan and therapists will receive regular supervision on skype.
      CBT was adapted using a series of qualitative studies (Naeem et al, 2010, 2009, 2010, 2009,
      accepted for publication, under review). An initial pilot project found this culturally
      adapted CBT for psychosis to be effective in Pakistan (Habib et al, unde review)

      TAU Group The Treatment As Uusual (TAU) group will receive only antipsychotic medication as
      prescribed by the psychiatrist, regular follow up and nursing care.

      STATISTICAL ANALYSES Both parametric and non parametric tests will be carried out. Initially
      data will be examined for errors in input. The analysis will be carried out on intention to
      treat basis using SPSS version 16.0. Initial analyses to compare the two groups were carried
      out using t test and χ2 test. A linear regression analysis will be used, with end of therapy
      as the dependent variable and group allocation, as independent variable. In order to see the
      effect of baseline differences in pre treatment scores on effect of therapy a second analysis
      was carried out with baseline scores entered as independent variables in addition to
      treatment groups (i.e., dependent variable post treatment scores, independent variable
      treatment group and pre treatment scores).
    

Intervention name(s): Brief CaCBTp
Intervention type(s): Behavioral
Intervention description(s): Brief CBT for psychosis is comonly used in the West and had an established evidence base. Recently this therapy has been culturally adapted for use with clients from Pakistan.
Other intervention name(s): RCT of Brief CaCBT for Psychosis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psychosis; Culture; CBT