Trial Outcomes & Findings for The Street Smart Group: A Feasibility Trial of a Group Intervention Targeting Anxiety Processes in Paranoia (NCT NCT02408198)

Results Overview

The GPTS consists of two 16-item scales. Ideas of reference (part A) and ideas of persecution (part B) are rated over the past month on a scale ranging from one (not at all) to five (totally). A total score is produced by summing all items for part A and B (minimum score = 32; maximum score = 160). A higher score indicates more paranoid thoughts.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

Assessed at baseline, at 6 weeks and 10 weeks

Results posted on

2020-02-18

Participant Flow

Participant milestones

Participant milestones
Measure	Immediate Therapy Therapy will be delivered for a period of 6 weeks immediately after randomisation Anxiety intervention: The intervention is based on a brief CBT for psychosis (CBTp) programme, focusing on understanding and managing anxiety processes that contribute to persecutory threat beliefs when in busy urban environments. The novel aspect of this intervention is that it is delivered in a group format. The intervention consists of six sessions which will be delivered on a weekly basis. Throughout the intervention there is an emphasis on setting tasks to practice applying the new skills outside of sessions, to help the person build confidence in being able to manage paranoia and feel less distressed in their daily life.	Delayed Therapy Therapy will be delayed until 10 weeks following randomisation, and then delivered over a 6 week period
Overall Study STARTED	13	5
Overall Study COMPLETED	10	5
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Street Smart Group: A Feasibility Trial of a Group Intervention Targeting Anxiety Processes in Paranoia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Immediate Therapy n=13 Participants Therapy will be delivered for a period of 6 weeks immediately after randomisation Anxiety intervention: The intervention is based on a brief CBT for psychosis (CBTp) programme, focusing on understanding and managing anxiety processes that contribute to persecutory threat beliefs when in busy urban environments. The novel aspect of this intervention is that it is delivered in a group format. The intervention consists of six sessions which will be delivered on a weekly basis. Throughout the intervention there is an emphasis on setting tasks to practice applying the new skills outside of sessions, to help the person build confidence in being able to manage paranoia and feel less distressed in their daily life.	Delayed Therapy n=5 Participants Therapy will be delayed until 10 weeks following randomisation, and then delivered over a 6 week period	Total n=18 Participants Total of all reporting groups
Age, Continuous	46.7 years STANDARD_DEVIATION 10.4 • n=5 Participants	46.6 years STANDARD_DEVIATION 8.5 • n=7 Participants	46.7 years STANDARD_DEVIATION 9.66 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized White	9 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed at baseline, at 6 weeks and 10 weeks

Population: A total of 18 participants were randomised. In the immediate therapy condition, 3 participants withdrew after baseline assessments and were not able to be contacted, 1 participant completed all assessments but did not feel able to attend the intervention. 1 participant was unable to complete all measures due to language difficulties and fatigue.

The GPTS consists of two 16-item scales. Ideas of reference (part A) and ideas of persecution (part B) are rated over the past month on a scale ranging from one (not at all) to five (totally). A total score is produced by summing all items for part A and B (minimum score = 32; maximum score = 160). A higher score indicates more paranoid thoughts.

Outcome measures

Outcome measures
Measure	Immediate Therapy n=10 Participants Therapy will be delivered for a period of 6 weeks immediately after randomisation Anxiety intervention: The intervention is based on a brief CBT for psychosis (CBTp) programme, focusing on understanding and managing anxiety processes that contribute to persecutory threat beliefs when in busy urban environments. The novel aspect of this intervention is that it is delivered in a group format. The intervention consists of six sessions which will be delivered on a weekly basis. Throughout the intervention there is an emphasis on setting tasks to practice applying the new skills outside of sessions, to help the person build confidence in being able to manage paranoia and feel less distressed in their daily life.	Delayed Therapy n=5 Participants Therapy will be delayed until 10 weeks following randomisation, and then delivered over a 6 week period
Green Paranoid Thoughts Scale (GPTS) Baseline	109.77 score on a scale Standard Deviation 13.18	114.6 score on a scale Standard Deviation 24.93
Green Paranoid Thoughts Scale (GPTS) 6 weeks (post therapy)	84.8 score on a scale Standard Deviation 38.72	82.6 score on a scale Standard Deviation 30.25
Green Paranoid Thoughts Scale (GPTS) 10 weeks (follow up)	82.1 score on a scale Standard Deviation 25.72	69 score on a scale Standard Deviation 36.22

Adverse Events

Immediate Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Amy Hardy

King's College London

Phone: 0207 848 0033

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place