Brief Culturally Adapted Cognitive Behaviour Therapy for Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Cognitive behaviour therapy (CBT) has an effective evidence base in the west and is
      recommended by the national bodies in many countries in the West. Our group has adapted CBT
      for depression and psychosis in Pakistan for use with local clients. Initial evaluations have
      found that these therapies are effective. However, due to the financial restraints it would
      be useful if the investigators find that brief version of the CBT might be applicable and
      effective in non western cultures. Therefore in this study, the investigators will be testing
      effectiveness of brief version of culturally adapted CBT for depression in a randomized
      controlled trial (RCT) in Pakistan.
    

Detailed description: 
      BACKGROUND There is a strong evidence base in favour of the CBT on its role in treating
      Depression and Anxiety (Embling et. al., 2002; Thase et. al., 2000; Rief. et .al, 2000)). CBT
      has been shown to be effective for prophylaxis (Shaw, 1989) and for the prevention of
      depressive relapse (Paykel et al, 1999, Fava et al; 1999). The current evidence suggests that
      Cognitive Behaviour Therapy (CBT) is as effective as antidepressants for treating depression
      (DeRubeis, Hollon et al. 1982; Murphy, Simons et al. 1984; Simons, Murphy et al. 1986), and
      is more effective than antidepressants in preventing relapse (Evans, Hollon et al. 1992;
      Hollon, DeRubeis et al. 1992). CBT is now included in national treatment guidelines in the
      USA and the UK (e.g. APA, 2004; NICE, 2004). However, in spite of the large body of the
      evidence suggesting effectiveness of the CBT for depression in the West, little progress has
      been made in its delivery in developing countries.

      Cognitive behavioral therapy for depression was developed by Beck (Beck et al, 1979). CBT
      focuses on "how depressed people think and perceive themselves, others and their future". The
      key aspects of therapy include, taking an educative approach, working in collaboration with
      the client and develop insights through a Socratic dialogue. The therapist helps the
      depressed person to learn to recognize his "negative thinking patterns" and to re-evaluate
      his thinking. Clients are asked to carry out exercises at home to learn new ways of dealing
      with their problems (called homework). Modern psychotherapies were developed in the west and
      hence are likely to be underpinned by western values. It is therefore believed that CBT might
      need modification before it can be used in the non-western cultures because it involves
      exploration and attempts to modify automatic thoughts and core beliefs (Padesky et al, 1995).
      A systematic literature search found few studies of cognitive therapy from the non western
      world. However, the research so far indicates towards effectiveness of this therapy
      (Sumathipala, 2008, Araya et al, 2003, Wong et al, 2008 & Rahman et al, 2009). We have
      adapted CBT for depression in Pakistan (Naeem et al, 2009) and a pilot study to evaluate the
      effectiveness of CBT has shown it to be effective (Naeem et al, 2011).

      The focus of the mental health services in Pakistan seem to be in the secondary care.
      Psychiatric services are available in major cities and patients come to see professionals
      from around the country. As such it seems only logical that we try to assess the
      effectiveness of CBT in secondary care. However, given the deficits in resources both human
      and financial, as well as based on the experience of our team, it will make more sense if we
      evaluate brief interventions. In this trial we would like to test the applicability of a
      brief culturally adapted CBT for patients with depression who attend secondary care in
      Pakistan.

      Methodology Objective To assess effectiveness of brief Culturally Sensitive CBT (CS-CBT) for
      depression against care as usual.

      Study design and duration This study is a Randomized Control Trial (RCT) which aims to assess
      effectiveness of brief Culturally Sensitive CBT (CS-CBT) against care as usual for
      depression. Study participants will be randomly assigned to two groups the intervention group
      will receive brief CBT developed and adapted for use in Pakistan using a series of
      qualitative studies (Naeem et.al 2009).

      Intervention focuses on psycho-education, symptoms management, changing negative thinking,
      behavioral activation, problem solving, improving relationships and communication skills. One
      person from the family will be involved in order to improve compliance with therapy and
      follow up. The intervention consists of 6 sessions, plus one additional session for family.

      The assessments will be carried out at the base line and then at the end of therapy (8
      weeks). Control group will receive care as usual. In Pakistan this usually means, contact
      with a medical professional and being on antidepressants. A number equal to intervention
      group will be employed in this group. Bind raters will be used to assess the change in
      depression.

      Inclusion and exclusion criteria All those who fulfill the diagnostic criteria of Depressive
      episode (F32) or Recurrent depressive disorder (F33 except 33.4 ) using ICD10 RDC (based on
      interviews using SCAN Urdu version), are between the ages of 18-60, score 8 or more on HADS,
      Depression Subscale, and who live within traveling distance of the psychiatry department will
      be approached. Those patients, who have agreed to enter the study, will be assessed 2 weeks
      later, to fill in the baseline measures when they attend their first appointment. Patients
      will be asked to attend a further appointment at the end of study period and will be assessed
      again.

      The exclusion criteria include; excessive use of alcohol or drugs (using ICD 10 RDC for
      alcohol or drug abuse or dependence) significant cognitive impairment (for example learning
      disability or dementia) and active psychosis.

      Procedure Patients who have been referred for the study will be provided brief information
      about the study. Those who meet the criteria and consent will be then asked to join the study
      and will be allocated to one arm of the trial after randomization.

      Sample size Based on our pilot study, we calculated sample size for larger trial based on
      comparison between groups in terms of the change in the HADS Depression scores. A difference
      of 2 units between groups would be of clinical importance. Pilot data suggests that the
      within group standard deviation of the change in values over time is 3 units. With a 5%
      significance level and 90% power it is calculated that 48 subjects per group are required, 96
      in total. It is expected that up to 30% of patients will drop out of the study. To allow for
      this it is planned to recruit 140 subjects into the study.

      Randomization Randomization will be performed distantly by a statistician, from the list of
      all the patients who have been accepted for each group. After randomization patients will be
      allocated to either treatment or the control arm. Randomization will be performed for each
      group separately.

      INSTRUMENTS The Bradford Somatic Inventory (BSI) (Mumford et al, 1991) is used to measure
      somatic symptoms. An Urdu version is available. It was developed in South Asia. It has been
      widely used. It has 45 items. Scores above 21 indicate depression. It was developed from
      symptom reports by psychiatric patients in Pakistan and Britain with clinical diagnoses of
      anxiety or depression. The BSI inquires about a wide range of somatic symptoms during the
      previous month, and if the subject has experienced a particular symptom, whether the symptom
      has occurred on more or less than 15 days during the month (scoring 2 or 1, respectively).

      The Hospital Anxiety and Depression Scale (HAD) (Zigmond and Snaith, 1983) is a 14 item, self
      assessment scale designed to measure anxiety and depression. It has a high internal
      consistency, face validity and concurrent validity. Even-numbered questions relate to
      depression and odd-numbered questions relate to anxiety. Each question has 4 possible
      responses. Responses are scored on a scale from 3 to 0. The maximum score is therefore 21 for
      depression and 21 for anxiety. A score of 11 or higher indicates the probable presence of the
      mood disorder with a score of 8 to 10 being just suggestive of the presence of the respective
      state. The two subscales, anxiety and depression, have been found to be independent measures.
      In its current form the HADS is now divided into four ranges: normal (0-7), mild (8-10),
      moderate (11-15) and severe (16-21).

      Brief Disability Questionnaire (BDQ) was developed by the WHO to measure disability due to
      physical and psychological problems and has been used extensively in research (Von Korff et
      al., 1996).

      A data form will be used to collect information from the client.

      Study sites Trial will be carried out in psychiatry departments in Lahore/Karachi, Pakistan
      Acknowledgements We will acknowledge the psychology graduates, R&D, LIRD and PACT for their
      support in publications.

      INTERVENTION Clients in intervention group will receive a CBT intervention using a manual.
      Intervention was developed for use in primary and secondary care using a series of
      qualitative studies (Naeem et al a, 2010, Naeem et al c, 2009, Naeem et al, 2009, Naeem et
      al, in press) during the last 5 years in Pakistan and has proven to be effective in a pilot
      study (Naeem et al, 2011). Intervention will consist of 6 sessions and will focus on
      psycho-education, symptoms management, changing negative thinking, problem solving, improving
      relationships and communication skills. One person from the family will be involved as a
      facilitator.

      Withdrawals and dropouts During our work in Pakistan to modify CBT for use in Pakistan, we
      have noticed that patients frequently drop out of therapy. We have incorporated techniques to
      address this issue in therapy manual, which improved drop out rates. These include giving the
      patients a direct number (can be a mobile phone or a wireless phone), contacting them once or
      twice a week to remind them of their homework and to attend the follow up sessions, speaking
      in client's language with minimum number of English terms and establishing a good rapport and
      a trusting relationship during the session. However, the risk of dropout remains high.
      Therefore, we will employ a higher number of clients in our study, with a probable dropout
      rate of 30%.

      Data entry and analysis Statistical analyses would be carried out using an intention to
      treat. Analyses will be carried out using SPSS v16 . Both parametric and non parametric tests
      will be carried out as appropriate to compare groups. An analysis of covariance will be used
      to measure the differences between the two groups at three time points, where the data is
      normally distributed. A t test will be used to compare groups, both paired and unpaired. SPSS
      frequency and descriptive commands will be used to measure descriptive statistics. SPSS
      explore command will be used to measure normality of the data, using histograms and
      Kolmorogov Smirnov test. If the therapy is proved to be more effective than the control, we
      will also use a binary logistic regression analysis to explore factors which predict good
      outcome. An intention to treat analysis will be performed. Number Needed to Treat (NNT) will
      be calculated to assist clinicians with clinical decision making.

      Research in clinically naturalistic settings It is recognized that such research is most
      likely to provide results that are relevant to routine clinical practice; the current study
      provides a more rigorous evaluation for an intervention that can be provided in current
      service in Pakistan and at no extra costs.
    

Intervention name(s): Ca CBT
Intervention type(s): Behavioral
Intervention description(s): Clients in intervention group will receive a CBT intervention using a manual. Intervention was developed for use in primary and secondary care using a series of qualitative studies (Naeem et al a, 2010, Naeem et al c, 2009, Naeem et al, 2009, Naeem et al, in press) during the last 5 years in Pakistan and has proven to be effective in a pilot study (Naeem et al, 2011). Intervention will consist of 6 sessions and will focus on psycho-education, symptoms management, changing negative thinking, problem solving, improving relationships and communication skills. One person from the family will be involved as a facilitator.
Other intervention name(s): Culturally adapted Brief Cognitive Behaviour Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depression; Culture; CBT; Adaptation