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Does Disciplined Personal Involvement Precede Change in CBASP?

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ClinicalTrials.gov Identifier: NCT02470988
Recruitment Status : Unknown
Verified June 2015 by University of Edinburgh.
Recruitment status was:  Active, not recruiting
First Posted : June 12, 2015
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh

Tracking Information
First Submitted Date  ICMJE June 10, 2015
First Posted Date  ICMJE June 12, 2015
Last Update Posted Date December 7, 2016
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2015)
Patient Health Questionnaire - 9 (PHQ-9) [ Time Frame: 6 months ]
Administered at three weekly baseline assessments and then at every therapy session for all participants over a period of 6 months or up to 20 sessions.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Disciplined Personal Involvement Precede Change in CBASP?
Official Title  ICMJE How is Psychological Change Experienced by Individuals Receiving Cognitive Behaviour Analysis System of Psychotherapy (CBASP) and How is This Affected by Disciplined Personal Involvement? A Multiple Baseline Single Case Design
Brief Summary The purpose of the study is to investigate the process of symptom change in Cognitive Behavioural Analysis System of Psychotherapy (CBASP), and how the individual components of the therapy affect this change in individuals with chronic depression.
Detailed Description

A form of psychotherapy called Behaviour Analysis System of Psychotherapy (CBASP) has been developed specifically to treat individuals suffering from chronic, long-standing depression. There is a growing evidence base to suggest that CBASP is effective for these individuals, especially when combined with anti-depressant medication. This evidence comes from case series and randomised controlled trials that have compared CBASP with other forms of therapy such as Interpersonal Psychotherapy and Cognitive Behaviour Therapy, and with medication. The evidence from these studies consistently shows CBASP to be effective, and it compares favourably with other forms of therapy.

Given these findings, it is important to understand how change happens in CBASP and how it is affected by the components of the therapy. Understanding how individuals experience change within CBASP will have important implications for how the therapy is delivered in the future. For example if change is found to be non-linear it would be important to understand what components of the therapy are associated with improvement. There could also be organisational implications, for example relating to the optimal number of sessions to offer in order to achieve acceptable change while balancing therapist time.

The proposed study aims to investigate the process of psychological change in CBASP. This will be done by providing CBASP to a small number of individuals and gathering outcome data (rating of mood) at every therapy appointment. Session--by-session change will then be mapped for each participant. The study will include two arms: CBASP; and CBASP without Disciplined Personal Involvement (DPI). DPI involves specifically using the therapist--client relationship to help the client to discriminate between previous maladaptive relationships and other, positive ones. The reason for including this condition is to investigate whether DPI affects the process of psychological change in CBASP, as it is a unique feature of the therapy.

The study will use a single-case design, as the aim is to map change within each individual participant in the context of the therapy. This design was deemed appropriate as the study does not aim to make claims about the overall effectiveness of CBASP, but to provide an analysis of individual psychological change for participants receiving CBASP.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Depression
Intervention  ICMJE
  • Behavioral: Cognitive Behavioural Analysis System of Psychotherapy
    Other Name: CBASP
  • Behavioral: CBASP Without DPI
Study Arms  ICMJE
  • Active Comparator: CBASP
    Cognitive Behavioural Analysis System of Psychotherapy (CBASP) is a form of therapy specifically designed to treat individuals with chronic depression. CBASP combines a number of elements, with a focus on teaching the client to become aware of their interpersonal behaviour and its consequences.
    Intervention: Behavioral: Cognitive Behavioural Analysis System of Psychotherapy
  • Experimental: CBASP Without DPI
    In this arm CBASP will be delivered without Disciplined Personal Involvement (DPI) by the therapist.
    Intervention: Behavioral: CBASP Without DPI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: December 6, 2016)
13
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2015)
12
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged between 18 and 64 years, inclusive
  • Have been depressed for 2 years or longer
  • Have had previous episodes of depression
  • Previous treatment (medication, psychotherapy or both) unsuccessful or participant has relapsed
  • Do not meet any of the exclusion criteria
  • Able to provide informed consent to participate in the study

Exclusion Criteria:

  • Received psychological therapy in previous 12 months
  • Current significant substance misuse
  • Presence of learning difficulties
  • Presence of psychosis
  • Unable to commit to the full duration of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02470988
Other Study ID Numbers  ICMJE 15/WS/0027
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Edinburgh
Study Sponsor  ICMJE University of Edinburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Edinburgh
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP