ACT-smart: Smartphone-supplemented iCBT for Social Phobia and/or Panic Disorder

Stockholm University

Status: Completed

Conditions: Panic Disorder; Phobic Disorders

Treatments: Behavioral: Therapist support; Other: Active waiting list; Behavioral: Smartphone-supplemented iCBT

Study type: Interventional

Funder types: Other

Identifiers

NCT01963806

ACT-smart

Details and patient eligibility

About

BACKGROUND: Smartphone technology presents a novel and promising opportunity to extend the reach of psychotherapeutic interventions by moving selected parts of the therapy into the real-life situations causing distress. This randomised controlled trial will investigate the effect of a transdiagnostic, Internet-administered cognitive behavioural (iCBT) self-help program for anxiety, supplemented with a tailored smartphone application. The effect of added therapist support will also be studied.

METHODS/DESIGN: 150 participants meeting diagnostic criteria for social anxiety disorder and/or panic disorder will be evenly randomised to one of three treatment arms: (1) smartphone-supplemented iCBT with therapist support; (2) smartphone-supplemented iCBT without therapist support; or (3) an active waiting list control group with delayed treatment. After the 10 week treatment period, the control group (3) will receive the same treatment as group (2). Primary outcome measure will be the Generalised Anxiety Disorder 7-item self-rating scale. Secondary measures include other anxiety, depression and quality of life measures. In addition to pre- and post-treatment measurements, the study includes two mid-treatment and two follow-up assessments (12 and 24 months).

HYPOTHESES: Based on prior research, we hypothesise that the therapist-guided form will be superior to the unguided form in reducing anxiety levels, and that both delivery modes will be superior to an active waiting-list control group.

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Satisfy DSM-IV-TR criteria for panic disorder and/or social anxiety disorder as assessed by the SCID.
• Daily access to the Internet via computer and smartphone
• Residing in Sweden and speaking sufficient Swedish to communicate with the research team

Exclusion criteria

• Parallel psychological treatment
• Non-stable dosage of psychoactive medication during last 3 months
• Participants deemed to suffer from suicidal tendencies or another condition requiring specialized treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 3 patient groups

Smartphone-supplemented iCBT with therapist support

Experimental group

Description:

n = 50

Treatment:

Behavioral: Smartphone-supplemented iCBT

Behavioral: Therapist support

Smartphone-supplemented iCBT without therapist support

Experimental group

Description:

n = 50

Treatment:

Behavioral: Smartphone-supplemented iCBT

Active waiting list control group with delayed treatment

Active Comparator group

Description:

n = 50

Treatment:

Other: Active waiting list

Behavioral: Smartphone-supplemented iCBT