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Intensive Rhythm Stabilisation for Bipolar Disorder

Effect of Social Rhythm and Bright Light Therapy on symptom burden in treatment resistant bipolar disorder

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001157864
Acronym
IRS study
Enrollment
8
Registered
2021-08-27
Start date
2021-10-20
Completion date
2023-07-11
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The most common approach to the treatment of the bipolar disorder (BD) is medication. There is good evidence that evidence-based psychotherapies also add to treatment efficacy. However, they are relatively rarely used because of resource issues. Some people with BD do not respond well to standard medication treatment (‘treatment resistance’). In this case, psychotherapy is clearly indicated, but seldom available. Disturbance in circadian and social rhythms is an important feature of BD and is more marked in patients who do not respond to treatment. Social Rhythm Therapy (SRT) is short psychotherapy that aims to address disturbance in circadian rhythms. The incorporation of Bright Light Therapy into this psychotherapy may have added benefit in stabilising sleep-wake cycles. This study will be an open-label, pilot study to determine whether Social Rhythm Therapy for BD, as well as Bright Light Therapy (SRT + Bright Light), is effective in improving mood, social rhythm stability, cognitive and general functioning, and quality of life. Twenty patients with treatment-resistant BD will receive SRT + Bright Light over a 12-week treatment period, with weekly individual therapy sessions and daily bright light exposure. Findings will help inform larger-scale studies of adjunctive chronobiological treatments for BD.

Interventions

Patients will recieve both Social rhythm therapy and Bright Light Therapy. SRT: Social Rhythm Therapy - a structured therapy delivered weekly over 12 weeks based on a stress-diathesis model of disruption to circadian rhythms focusing on stabilisation of the social rhythms that underpin circadian rhythms. SRT 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 reg

Patients will recieve both Social rhythm therapy and Bright Light Therapy. SRT: Social Rhythm Therapy - a structured therapy delivered weekly over 12 weeks based on a stress-diathesis model of disruption to circadian rhythms focusing on stabilisation of the social rhythms that underpin circadian rhythms. SRT 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). A range of strategies for addressing disruption to the sleep/wake cycle is utilised, including setting a regular wake time, avoiding blue light in the evening, incorporating wind down activities into sleep preparation, ensuring the stability of key social rhythms (e.g. daily activities and eating), daily scheduling of work and recreational activities, discouraging naps during daylight hours, utilising stimulus control strategies for use of the bedroom, and exposure to morning bright light and dim evening light. This therapy, in contrast to other evidence-based psychotherapies for BD, is relatively short and easily trained, so it may be more practical and likely to be adopted in routine practice. In the current study, SRT will be provided by trained therapists in an individual format. Each session will be one hour and will occur weekly for 12 weeks. According to a manualised protocol (developed with the University of Pittsburgh) and supervised by an experienced therapist, therapy will be delivered according to a manualised protocol (developed with the University of Pittsburgh). All sessions will be audio-taped and 10% will be randomly selected and rated to ensure adherence to therapy protocols. Bright Light: Bright Light Therapy (BLT) patients will be provided with a lightbox (Daylight Simulator “Day-Light” Classic Model) to deliver 30 minutes of bright light at approximately 10,000 lux, for 12 weeks. Exposure will occur daily at midday, with the exact schedule being determined by a predictive algorithm based on Morningness-Eveningness Questionnaire scores. Treatment adherence will be monitored by daily logs of device treatment times completed by patients and reviewed at each therapy session.

Sponsors

University of Otago, Christchurch
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

(i) aged over 18 years, (ii) currently under community mental health service care, (iii) diagnosis of Bipolar I or Bipolar II Disorder, and (iv) treatment-resistance, defined as being in treatment with mental health services for at least 9 months and with no planned discharge within the coming six months.

Exclusion criteria

(i) BD not the primary diagnosis, (ii) unable to provide informed consent, (iii) unable to participate in 12-week psychotherapy, and (iv) unable to undergo bright light exposure (e.g., retinal disease, light sensitivity).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026