NCT01876056

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable schizophrenia

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

October 29, 2014

Status Verified

October 1, 2014

Enrollment Period

1.4 years

First QC Date

April 29, 2013

Last Update Submit

October 27, 2014

Conditions

Schizophrenia

Keywords

PsychosisCultureCBT

Outcome Measures

Primary Outcomes (1)

  • PANSS (Positive and Negative Syndrome Scale of Schizophrenia)Positive symptoms

    Measurement of positive symptoms

    Participants will be assessed at baseline and then end of therapy at 12 weeks

Secondary Outcomes (3)

  • PANSS (Positive and Negative Syndrome Scale of Schizophrenia)Negative symptoms

    Participants will be assessed at baseline and then end of therapy at 12 weeks

  • PSYRATS (Psychotic Symptom Rating Scales)

    Participants will be assessed at baseline and then end of therapy at 12 weeks

  • Schedule for Assessment of Insight

    Participants will be assessed at baseline and then end of therapy at 12 weeks

Study Arms (2)

Brief CaCBTp

EXPERIMENTAL

The experimental group will receive brief for of Culturally adapted CBT for psychossis

Behavioral: Brief CaCBTp

Treatment As Usual

NO INTERVENTION

Treatment as usual means seeing a mental health professional and taking the prescribed anti psychotics and being cared by family members

Interventions

Brief CaCBTpBEHAVIORAL

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.

Also known as: RCT of Brief CaCBT for Psychosis
Brief CaCBTp

Eligibility Criteria

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

You may qualify if:

  • being able to engage with a therapist,
  • living within travelling distance of the hospital, and
  • with a diagnosis of Schizophrenia according to DSM-IV-TR (Association \& DSM-IV, 2000),
  • age between 18 to 65 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Association of Cognitive Therapists

Lahore, Pakistan

Location

Related Publications (11)

  • Ahmer S, Faruqui RA, Aijaz A. Psychiatric rating scales in Urdu: a systematic review. BMC Psychiatry. 2007 Oct 26;7:59. doi: 10.1186/1471-244X-7-59.

    PMID: 17963494BACKGROUND

  • Turkington D, Kingdon D, Turner T; Insight into Schizophrenia Research Group. Effectiveness of a brief cognitive-behavioural therapy intervention in the treatment of schizophrenia. Br J Psychiatry. 2002 Jun;180:523-7. doi: 10.1192/bjp.180.6.523.

    PMID: 12042231BACKGROUND

  • David A, Buchanan A, Reed A, Almeida O. The assessment of insight in psychosis. Br J Psychiatry. 1992 Nov;161:599-602. doi: 10.1192/bjp.161.5.599.

    PMID: 1422606BACKGROUND

  • Haddock G, McCarron J, Tarrier N, Faragher EB. Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychol Med. 1999 Jul;29(4):879-89. doi: 10.1017/s0033291799008661.

    PMID: 10473315BACKGROUND

  • Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.

    PMID: 3616518BACKGROUND

  • Wykes T, Steel C, Everitt B, Tarrier N. Cognitive behavior therapy for schizophrenia: effect sizes, clinical models, and methodological rigor. Schizophr Bull. 2008 May;34(3):523-37. doi: 10.1093/schbul/sbm114. Epub 2007 Oct 25.

    PMID: 17962231BACKGROUND

  • Naeem F, Ayub M, Kingdon D, Gobbi M. Views of depressed patients in Pakistan concerning their illness, its causes, and treatments. Qual Health Res. 2012 Aug;22(8):1083-93. doi: 10.1177/1049732312450212. Epub 2012 Jun 15.

    PMID: 22707343BACKGROUND

  • Farooq S, Nazar Z, Irfan M, Akhter J, Gul E, Irfan U, Naeem F. Schizophrenia medication adherence in a resource-poor setting: randomised controlled trial of supervised treatment in out-patients for schizophrenia (STOPS). Br J Psychiatry. 2011 Dec;199(6):467-72. doi: 10.1192/bjp.bp.110.085340.

    PMID: 22130748BACKGROUND

  • Naeem F, Waheed W, Gobbi M, Ayub M, Kingdon D. Preliminary evaluation of culturally sensitive CBT for depression in Pakistan: findings from Developing Culturally-sensitive CBT Project (DCCP). Behav Cogn Psychother. 2011 Mar;39(2):165-73. doi: 10.1017/S1352465810000822. Epub 2010 Nov 19.

    PMID: 21092353BACKGROUND

  • Naeem F, Gobbi M, Ayub M, Kingdon D. Psychologists experience of cognitive behaviour therapy in a developing country: a qualitative study from Pakistan. Int J Ment Health Syst. 2010 Jan 28;4(1):2. doi: 10.1186/1752-4458-4-2.

    PMID: 20181039BACKGROUND

  • Javed Z, Naeem F, Kingdon D, Irfan M, Izhar N, Ayub M. Attitude of the university students and teachers towards mentally ill, in Lahore, Pakistan. J Ayub Med Coll Abbottabad. 2006 Jul-Sep;18(3):55-8.

    PMID: 17348315BACKGROUND

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • farooq naeem, MRCPsych,PhD

    Pakistan Association of Cognitive Therapists

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President, Pakistan Association of Cognitive Therapists

Study Record Dates

First Submitted

April 29, 2013

First Posted

June 12, 2013

Study Start

February 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

October 29, 2014

Record last verified: 2014-10

Locations

PA(1)