Physical Exercise Augmented CBT for GAD (PEXACOG)

Solli Distriktspsykiatriske Senter

Status: Active, not recruiting

Conditions: Generalized Anxiety Disorder

Treatments: Behavioral: Cognitive Behavioural Therapy; Behavioral: Placebo control; Behavioral: Physical Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02690441

971427272T1

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 60 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

CBT augmented with physical exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Physical Exercise

Behavioral: Cognitive Behavioural Therapy

CBT and placebo control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Placebo control

Behavioral: Cognitive Behavioural Therapy