---
title: Physical Exercise Augmented CBT for GAD
nct_id: NCT02690441
overall_status: ACTIVE_NOT_RECRUITING
phase: NA
sponsor: Solli Distriktspsykiatriske Senter
study_type: INTERVENTIONAL
primary_condition: Generalized Anxiety Disorder
countries: Norway
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02690441.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02690441"
ct_last_update_post_date: 2026-04-28
last_seen_at: "2026-05-12T06:20:39.086Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Physical Exercise Augmented CBT for GAD

**Official Title:** Physical Exercise Augmented Cognitive Behaviour Therapy for Older Adults With Generalised Anxiety Disorder

**NCT ID:** [NCT02690441](https://clinicaltrials.gov/study/NCT02690441)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 53
- **Lead Sponsor:** Solli Distriktspsykiatriske Senter
- **Collaborators:** 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
- **Conditions:** Generalized Anxiety Disorder
- **Start Date:** 2016-03
- **Completion Date:** 2026-12
- **CT.gov Last Update:** 2026-04-28

## Brief Summary

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.

## Eligibility

- **Minimum age:** 60 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **CBT augmented with physical exercise** (EXPERIMENTAL) — 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.
- **CBT and placebo control** (ACTIVE_COMPARATOR) — 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.

## Interventions

- **Cognitive Behavioural Therapy** (BEHAVIORAL) — Cognitive behavioural therapy conducted individually. 10 weekly sessions, first session lasts 90 minutes, the remaining sessions last 45 minutes.
- **Physical Exercise** (BEHAVIORAL) — Manualised exercise. 15 weekly sessions with instructor, and two weekly unsupervised sessions performed individually.
- **Placebo control** (BEHAVIORAL) — 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.

## Primary Outcomes

- **Changes in The Penn State Worry Questionnaire** _(time frame: 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)_ — Assesses symptom severity of GAD
- **Change in clinical diagnosis after treatment assessed by independent, blinded rater with Anxiety Disorders Interview Schedule (ADIS-IV)** _(time frame: Baseline and post-treatment (up to 20 weeks after baseline))_ — Remission rates. Assessed by independent, blinded rater with Anxiety Disorders Interview Schedule (ADIS-IV)

## Secondary Outcomes

- **Geriatric Anxiety Inventory** _(time frame: 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)_
- **Generalized Anxiety Disorder 7-item scale (GAD-7)** _(time frame: 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)_
- **Beck Anxiety Inventory** _(time frame: 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)_
- **Beck Depression Inventory - II** _(time frame: 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)_
- **Bergen Insomnia Scale** _(time frame: 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)_
- **Quality of Life Inventory** _(time frame: 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)_
- **International Physical Activity Questionnaire (IPAQ)** _(time frame: 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)_
- **5-item Treatment Credibility and Expectancy Scale (CES)** _(time frame: Baseline)_

## Locations (1)

- Solli DPS, Bergen, Nesttun, Norway

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.solli dps|bergen|nesttun|norway` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT02690441*  
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