- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02470988
Does Disciplined Personal Involvement Precede Change in CBASP?
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Dundee, United Kingdom
- NHS Tayside
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Edinburgh, United Kingdom
- NHS Lothian
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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Other Names:
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Experimental: CBASP Without DPI
In this arm CBASP will be delivered without Disciplined Personal Involvement (DPI) by the therapist.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patient Health Questionnaire - 9 (PHQ-9)
Time Frame: 6 months
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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.
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6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15/WS/0027
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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