Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Does Disciplined Personal Involvement Precede Change in CBASP?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Chronic Depression Behavioral: Cognitive Behavioural Analysis System of Psychotherapy Behavioral: CBASP Without DPI Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: Cognitive Behavioural Analysis System of Psychotherapy
Other Name: CBASP

Experimental: CBASP Without DPI
In this arm CBASP will be delivered without Disciplined Personal Involvement (DPI) by the therapist.
Behavioral: CBASP Without DPI



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470988


Locations
Layout table for location information
United Kingdom
NHS Tayside
Dundee, United Kingdom
NHS Lothian
Edinburgh, United Kingdom
Sponsors and Collaborators
University of Edinburgh
Layout table for additonal information
Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02470988    
Other Study ID Numbers: 15/WS/0027
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: June 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Behavioral Symptoms