Physical Exercise Augmented CBT for GAD (PEXACOG)

Physical Exercise Augmented Cognitive Behaviour Therapy for Older Adults With Generalised Anxiety Disorder

University of Bergen, Norwegian University of Science and Technology, University of Oslo, University of California, Berkeley, William Paterson University of New Jersey, Ohio State University

Generalised anxiety disorder (GAD) is a severe and debilitating anxiety disorder that is highly prevalent among older adults. Anxiety and GAD is a well-documented risk factor for the development of other severe conditions such as depression and dementia, and effective treatments are called for. However, recommended treatment for GAD has consistently been found to yield blunted response rates for older adults compared to younger patients. The purpose of this study is to evaluate the effects of exercise-augmented cognitive behaviour therapy for older adults with GAD. Exercise augmented CBT is expected to yield better results than standard CBT in terms of greater reduction of symptoms and increased rates of remission. The investigators will also investigate the effects of treatment on biological, physiological and neuropsychological measures.

Patients receive 10 sessions of cognitive behavioural therapy for generalized anxiety disorder. Patients also receive 5 weeks of physical exercise pre-treatment, and 10 weeks of physical exercise alongside CBT. Both treatment and physical exercise is administered individually.

Patients receive 10 sessions of cognitive behavioural therapy for generalized anxiety disorder. Patients also receive 5 weeks of placebo control (15 minutes telephone follow-up call each week) pre-treatment, and 10 weeks of attention placebo alongside CBT. Both treatment and placebo control is administered individually.

Cognitive behavioural therapy conducted individually. 10 weekly sessions, first session lasts 90 minutes, the remaining sessions last 45 minutes.

Manualised exercise. 15 weekly sessions with instructor, and two weekly unsupervised sessions performed individually.

One follow-up telephone call à 15 minutes each week for 15 weeks. Aims to control for therapist contact in physical exercise condition and total duration of treatment.

Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up

Change in clinical diagnosis after treatment assessed by independent, blinded rater with Anxiety Disorders Interview Schedule (ADIS-IV)

Remission rates. Assessed by independent, blinded rater with Anxiety Disorders Interview Schedule (ADIS-IV)

Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up

Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up

Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up

Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up

Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up

Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up

Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up

Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up

Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up

Three subtests from Delis-Kaplan Executive Function System battery (D-KEFS; Delis, Kaplan & Kramer, 2001)

Wisconsin Card Sorting Test: Computer Version 4 research edition (WCST-CV4; Heaton, PAR staff & Goldin 2003).

Two subtests from Wechsler Abbreviated Scale of Intelligence (WASI; Wechsler, 1999) will be administered to assess IQ level.

Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up

Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up

Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up

Inclusion Criteria: Primary diagnosis of GAD Exclusion Criteria: Substance abuse Use of benzodiazepines, use of antipsychotica Lack of ability to stabilize other psychotropic medication during participating in the study Medical condition that precludes participation in physical exercise Severe major depression as determined by the MINI International Neuropsychiatric Interview Life-time history of psychosis and/or mania Participation in other ongoing psychotherapy Organic brain disease Positive screening for dementia with Mini Mental State Examination Currently engaged in a regular physical exercise program

Stavestrand SH, Sirevag K, Nordhus IH, Sjobo T, Endal TB, Nordahl HM, Specht K, Hammar A, Halmoy A, Martinsen EW, Andersson E, Hjelmervik H, Mohlman J, Thayer JF, Hovland A. Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): study protocol for a randomized controlled trial. Trials. 2019 Mar 18;20(1):174. doi: 10.1186/s13063-019-3268-9. Erratum In: Trials. 2020 Apr 6;21(1):317.