ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001348347p

Ethics application status

Submitted, not yet approved

Date submitted

13/09/2017

Date registered

25/09/2017

Date last updated

17/10/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Social rhythm therapy for treatment-resistant Bipolar Disorder

Scientific title

Effect of social rhythm therapy on mood symptoms for treatment-resistant Bipolar Disorder

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

SRT-TR

Linked study record

None

Health condition

Health condition(s) or problem(s) studied:

Bipolar Disorder

Condition category

Condition code

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Social rhythm therapy is an adaptation of Interpersonal and Social Rhythm Therapy. It is 12-session face-to-face and online course of Social Rhythm Therapy over 12-14 weeks. In most cases this will be completed over 12 weeks but in order to maintain a patient-centred approach we have built in the flexibility for an extension of two weeks if patients are unable to attend some sessions.
The goals of SRT are to improve sleep quality, monitor and assess social rhythmicity, regularise social rhythms in the context of promoting self-awareness of how BD is impacting on each person’s life. It is a structured therapy and incorporates two generic psychotherapy components (promotion of self-awareness and articulation of the experience of BD symptoms) and one specific component (promotion of social rhythm regularity). It will be delivered by psychotherapists with at least 6 years experience in the Psychological Medicine Clinical Research Unit, University of Otago, Christchurch. The intervention will be delivered as 1 x one hour session per week for 12 sessions.
The intervention is manualised and sessions will be audio-recorded and reviewed by a psychotherapy supervisor. Fidelity will be assessed using an adaptation of the fidelity scale developed by Frank et al 2005.

Intervention code [1]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Mood symptoms measured using The Longitudinal Interval Follow-up Evaluation (LIFE) (Keller et al. 1987)

Timepoint [1]

Baseline and 6 months from baseline.

Secondary outcome [1]

Quality of life assessed using QoL-BD (Michalak and Murray 2010)

Timepoint [1]

Baseline, following 12 session of SRT and 6 months from baseline

Secondary outcome [2]

Social rhythm stability measured using social rhythm matrix (Frank 2005)

Timepoint [2]

From baseline daily for two weeks; daily following during weeks 11 and 12 of SRT; and 6 months from baseline

Secondary outcome [3]

Level of functioning using The Functioning Assessment Short Test (Rosa et al. 2007)

Timepoint [3]

Baseline, following 12 sessions of SRT and 6 months from baseline

Eligibility

Key inclusion criteria

aged 18 years +; currently under community mental health service care; diagnosis of Bipolar I or Bipolar II; treatment resistant BD (have been in treatment with mental health services for two years during which time they have spent at least 4 months in each year in an episode of depression, mania, hypomania or mixed mood); must have been trialled on three mood stabilisers including a trial of Lithium; able to access internet.

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

BD not primary diagnosis; unable to provide informed consent; unable to participate in a 12-week psychotherapy.

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The primary analysis will compare scores on LIFE (mood symptoms) generated at baseline (from the 6 months prior to baseline) and those generated 6 months post baseline (from the 6 months after baseline) using paired T-tests. Other comparisons will also be by simple paired t-tests in order to generate effect size differences to power a more definitive randomised controlled trial.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

22/01/2018

Actual

Date of last participant enrolment

Anticipated

6/12/2019

Actual

Date of last data collection

Anticipated

6/06/2020

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago, Christchurch

Address [1]

4 Oxford Tce
Christchurch
8011

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Otago, Christchurch

Address

4 Oxford Tce
Christchurch
8011

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

HDEC

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

10/10/2017

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

While medication is considered the first line of treatment in BD, there is increasing evidence that the course of BD can be further modified by interventions targeted at the social and environmental context. Most people with BD are discharged within 4-6 months there is a sub-group who spend years on community mental health service caseloads because they do not respond to medication, may have a rapid cycling form of the disorder and/or do not recover from mood episodes. There are no formal adjunctive therapies available for BD in usual practice. 
SRT is a clinical adaptation of Interpersonal and Social Rhythm Therapy (IPSRT) (Frank 2005). It is based on the stress-vulnerability model.
Design
This study is an open-label trial of SRT for patients under the care of community mental health services with treatment resistant BPD. The aim of the study is to examine whether SRT is effective in stabilizing social rhythms in patients with treatment resistant BD.
	Participants
Twenty patients will be recruited from community mental health services for 12 weeks of SRT as an adjunct to their usual care. Participants will remain under the care of mental health services but will have weekly one-hour SRT sessions. 
Primary hypothesis: Following 12 sessions of SRT and 6 months from baseline patients will demonstrate improved mood symptoms.
Secondary hypotheses: Following 12 weeks of SRT patients will have:
o	Improvement in quality of life
o	Improvement in social rhythm stability
o	Improvement in level of functioning
Measurement:
•	Mood symptoms will be measured using The Longitudinal Interval Follow-up Evaluation (LIFE) (Keller et al. 1987) at baseline and 6 months to determine the occurrence of episodes of hypomania, major depressive disorder or mania.
•	Stability in social rhythms will be measured using the Social Rhythm Matrix (Monk et al. 1991). This is a daily self-report of social rhythm activities: sleep, eating, activities. Stability will be measured as < 45-minute discrepancy between the times of target and actual social rhythms. Stability is defined as a score indicating that all social rhythms have been occurring within a 45-minute window over the final 2 weeks of SRT.
•	Quality of life will be measured using QoL-BD (Michalak and Murray 2010) a validated measure for those with BD.
•	Level of functioning will be measured using The Functioning Assessment Short Test (Rosa et al. 2007).
Qualitative interviews
Qualitative interviews will be conducted at baseline exploring the participants’ experiences of BD and treatment, and their perceptions on what they need to recover. 
The primary analysis will compare scores generated at baseline (from the 6 months prior to baseline) and those generated 6 months post baseline (from the 6 months after baseline) using paired T-tests. Other comparisons will also be by simple paired t-tests in order to generate effect size differences.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Richard Porter

Address

Dept of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8011

Country

New Zealand

Phone

+64 3 3720400

Fax

richard.porter@otago.ac.nz

Contact person for public queries

Name

Professor Richard Porter

Address

Dept of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8011

Country

New Zealand

Phone

+64 3 3720400

Fax

richard.porter@otago.ac.nz

Contact person for scientific queries

Name

Richard Porter

Address

Dept of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8011

Country

New Zealand

Phone

+64 3 3720400

Fax

richard.porter@otago.ac.nz

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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