Trial Outcomes & Findings for Body Signal Integration Training: A Case Series (NCT NCT05941702)

Results Overview

This is a measure of adherence to the intervention. 80% of participants attending 80% of sessions offered will be considered acceptable adherence

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

8 weeks (span of intervention delivery)

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Full session plan of the 8 sessions is uploaded to documents. This arm will consist of weekly 1 hour 1:1 sessions with Trainee Clinical Psychologist doing exercises aimed at improving interoception. Exercises will include tuning into the body under different circumstances e.g., while having a drink, looking at pictures to induce a positive mood state. Body Signal Integration Training: Information and protocol uploaded to documents.
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Body Signal Integration Training: A Case Series

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=8 Participants Full session plan of the 8 sessions is uploaded to documents. This arm will consist of weekly 1 hour 1:1 sessions with Trainee Clinical Psychologist doing exercises aimed at improving interoception. Exercises will include tuning into the body under different circumstances e.g., while having a drink, looking at pictures to induce a positive mood state. Body Signal Integration Training: Information and protocol uploaded to documents.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	36 years STANDARD_DEVIATION 11 • n=99 Participants
Sex: Female, Male Female	7 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants
Race/Ethnicity, Customized White British	4 Participants n=99 Participants
Race/Ethnicity, Customized Caribbean	1 Participants n=99 Participants
Race/Ethnicity, Customized Black/Black British/Caribbean	1 Participants n=99 Participants
Race/Ethnicity, Customized Mixed Ethnicity	1 Participants n=99 Participants
Race/Ethnicity, Customized White European	1 Participants n=99 Participants

PRIMARY outcome

Timeframe: 8 weeks (span of intervention delivery)

Population: Number of participants that completed intervention

This is a measure of adherence to the intervention. 80% of participants attending 80% of sessions offered will be considered acceptable adherence

Outcome measures

Outcome measures
Measure	Intervention n=8 Participants Full session plan of the 8 sessions is uploaded to documents. This arm will consist of weekly 1 hour 1:1 sessions with Trainee Clinical Psychologist doing exercises aimed at improving interoception. Exercises will include tuning into the body under different circumstances e.g., while having a drink, looking at pictures to induce a positive mood state. Body Signal Integration Training: Information and protocol uploaded to documents.
Number of Participants That Complete 80% of the Intervention	7 Participants

PRIMARY outcome

Timeframe: 8 weeks (span of intervention delivery)

Measure of acceptability of intervention

Outcome measures

Outcome measures
Measure	Intervention n=7 Participants Full session plan of the 8 sessions is uploaded to documents. This arm will consist of weekly 1 hour 1:1 sessions with Trainee Clinical Psychologist doing exercises aimed at improving interoception. Exercises will include tuning into the body under different circumstances e.g., while having a drink, looking at pictures to induce a positive mood state. Body Signal Integration Training: Information and protocol uploaded to documents.
Number of Participants Rating the Therapy as Acceptable on Questionnaire of Therapy Satisfaction	7 Participants

PRIMARY outcome

Timeframe: 8 weeks (span of the intervention delivery)

Population: Number of participants that experienced adverse reaction to treatment

Number of serious adverse reactions will be a measure of feasibility and acceptability of the intervention

Outcome measures

Outcome measures
Measure	Intervention n=8 Participants Full session plan of the 8 sessions is uploaded to documents. This arm will consist of weekly 1 hour 1:1 sessions with Trainee Clinical Psychologist doing exercises aimed at improving interoception. Exercises will include tuning into the body under different circumstances e.g., while having a drink, looking at pictures to induce a positive mood state. Body Signal Integration Training: Information and protocol uploaded to documents.
Number of Serious Adverse Reactions as Evidenced by Significant Increase in Distress or Symptom Rating on Euroqol Health Questionnaire (EQ5D), Clinical Outcomes in Routine Evaluation (CORE-10) or FND Questionnaire	0 Participants

SECONDARY outcome

Timeframe: Approximately 3 months - measure will be from baseline measure completion to end of therapy

Measure of treatment efficacy

Outcome measures

Outcome measures
Measure	Intervention n=7 Participants Full session plan of the 8 sessions is uploaded to documents. This arm will consist of weekly 1 hour 1:1 sessions with Trainee Clinical Psychologist doing exercises aimed at improving interoception. Exercises will include tuning into the body under different circumstances e.g., while having a drink, looking at pictures to induce a positive mood state. Body Signal Integration Training: Information and protocol uploaded to documents.
Number of Participants Showing a Reliable Change Reduction in Core FND Symptoms as Measured by Screening for Somatic Symptom Disorders (SOMS-7)	3 Participants

SECONDARY outcome

Timeframe: Approximately 3 months - measure will be from baseline completion until end of therapy

Number of Participants with a Clinically Significant Change of Interoception Measuring Treatment Efficacy

Outcome measures

Outcome measures
Measure	Intervention n=7 Participants Full session plan of the 8 sessions is uploaded to documents. This arm will consist of weekly 1 hour 1:1 sessions with Trainee Clinical Psychologist doing exercises aimed at improving interoception. Exercises will include tuning into the body under different circumstances e.g., while having a drink, looking at pictures to induce a positive mood state. Body Signal Integration Training: Information and protocol uploaded to documents.
Number of Particip	5 Participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intervention n=8 participants at risk Full session plan of the 8 sessions is uploaded to documents. This arm will consist of weekly 1 hour 1:1 sessions with Trainee Clinical Psychologist doing exercises aimed at improving interoception. Exercises will include tuning into the body under different circumstances e.g., while having a drink, looking at pictures to induce a positive mood state. Body Signal Integration Training: Information and protocol uploaded to documents.
Social circumstances Psychological Distress	12.5% 1/8 • Number of events 1 • 3 months No unanticipated adverse events occurred or serious adverse events occurred. One individual reported increased awareness of FND symptoms and associated distress, they chose to drop out of the study and subsequently contacted researchers to inform symptoms had resolved - this was deemed an 'anticipated adverse reaction' to treatment. No further events/reactions occurred during the trial

Additional Information

Krishna Panchmatia

University of Manchester

Phone: 07857543272

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place