NCT02470988

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 23, 2021

Status Verified

June 1, 2021

Enrollment Period

1.5 years

First QC Date

June 10, 2015

Last Update Submit

June 22, 2021

Conditions

Chronic Depression

Outcome Measures

Primary Outcomes (1)

  • Patient Health Questionnaire - 9 (PHQ-9)

    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.

    6 months

Study Arms (2)

CBASP

ACTIVE COMPARATOR

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

CBASP Without DPI

EXPERIMENTAL

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

Behavioral: CBASP Without DPI

Interventions

Cognitive Behavioural Analysis System of PsychotherapyBEHAVIORAL
Also known as: CBASP
CBASP
CBASP Without DPIBEHAVIORAL
CBASP Without DPI

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Able to provide informed consent to participate in the study
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NHS Tayside

Dundee, United Kingdom

Location

NHS Lothian

Edinburgh, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 12, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 23, 2021

Record last verified: 2021-06

Locations

GB(2)