Trial Outcomes & Findings for One-Day Acceptance and Commitment Training Intervention in Primary Care Patients (NCT NCT01879800)

Last Updated: 2017-05-25

Results Overview

The World Health Organization Quality of Life Measure- Physical scale assesses quality of life in physical health- specifically in activities of daily living, Dependence on medicinal substances and medical aids, Energy and fatigue, Mobility, Pain and discomfort, Sleep and rest, and Work Capacity. Outcome measure will be the change from baseline, at 3, and 6 months. Each item ranges in score from 1-5. Individual items are rated on a 5 point Likert scale where 1 indicates low, negative perceptions and 5 indicates high, positive perceptions. As such, domain and facet scores are scaled in a positive direction where higher scores denote higher quality of life. The mean score of the items within this physical domain is used to calculate the overall physical domain score. Mean scores are then multiplied by 4, yielding a score of 4 to 20. A higher domain score indicates a higher quality of life in physical ability.

Recruitment status

COMPLETED

Study phase

Target enrollment

44 participants

Primary outcome timeframe

Change at 3 and 6- Month Follow-up

Results posted on

2017-05-25

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment As Usual/Waitlist Treatment As Usual/Waitlist	Acceptance and Commitment Therapy Plus Illness Management Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations . Acceptance and Commitment Therapy plus Illness Management
Overall Study STARTED	14	30
Overall Study COMPLETED	14	26
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One-Day Acceptance and Commitment Training Intervention in Primary Care Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment As Usual/Waitlist n=14 Participants Treatment As Usual/Waitlist	Acceptance and Commitment Therapy Plus Illness Management n=30 Participants Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations . Acceptance and Commitment Therapy plus Illness Management	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	30 Participants n=7 Participants	44 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	45 Years n=5 Participants	45 Years n=7 Participants	45 Years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	21 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	30 participants n=7 Participants	44 participants n=5 Participants
Completed College Completed College	10 Participants n=5 Participants	21 Participants n=7 Participants	31 Participants n=5 Participants
Completed College Did Not Complete College	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Employed Employed	10 Participants n=5 Participants	26 Participants n=7 Participants	36 Participants n=5 Participants
Employed Unemployed	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
On Antidepressant medication On Antidepressants	9 participants n=5 Participants	15 participants n=7 Participants	24 participants n=5 Participants
On Antidepressant medication Not on Antidepressants	5 participants n=5 Participants	15 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Change at 3 and 6- Month Follow-up

Outcome measures

Outcome measures
Measure	Treatment As Usual/Waitlist n=14 Participants Treatment As Usual/Waitlist	Acceptance and Commitment Therapy Plus Illness Management n=26 Participants Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations . Acceptance and Commitment Therapy plus Illness Management
Mean Change in Participants World Health Organization Quality of Life Measure- Physical Score: Change From Baseline to 3 and 6 Month Follow-up. 3 Month Change from baseline	.85 units on a scale Standard Error 1	2.8 units on a scale Standard Error .7
Mean Change in Participants World Health Organization Quality of Life Measure- Physical Score: Change From Baseline to 3 and 6 Month Follow-up. 6 Month Change from baseline	1.9 units on a scale Standard Error 1	4.1 units on a scale Standard Error .7

SECONDARY outcome

Timeframe: 3-month and 6-Month Follow-Up

The HAM-D is a structured clinical interview for assessing depression severity. Outcome measure will be change from Baseline in Hamilton Depression Rating Scale and at 3 and 6 month follow-ups. Measure is scored by adding individual items and attaining an overall severity score. Scores range from 0 to 53, with higher values signifying a higher level of depression severity (and thus a worse outcome). A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.

Outcome measures

Outcome measures
Measure	Treatment As Usual/Waitlist n=14 Participants Treatment As Usual/Waitlist	Acceptance and Commitment Therapy Plus Illness Management n=26 Participants Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations . Acceptance and Commitment Therapy plus Illness Management
Mean Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 3 and 6 Month Follow-up 3 month change from baseline	-2.8 units on a scale Standard Deviation 2.1	-9.9 units on a scale Standard Deviation 1.4
Mean Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 3 and 6 Month Follow-up 6 month change from baseline	-.8 units on a scale Standard Deviation 2.5	-11.7 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 3- and 6- Month Follow-Up

The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety. Each item is scored independently based on a five-point, ratio scale. Upon the completion of the evaluation, the clinician compiles a total, composite score based upon the summation of each of the 14 individually rated items. This calculation will yield a comprehensive score in the range of 0 to 56. It has been predetermined that the results of the evaluation can be interpreted as follows. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. A score of 25 to 30 indicates a moderate to severe anxiety severity. Lastly, a score above 30 represents severe anxiety severity. The mean change in ratings will be assessed from baseline to 3 and 6 months follow up.

Outcome measures

Outcome measures
Measure	Treatment As Usual/Waitlist n=14 Participants Treatment As Usual/Waitlist	Acceptance and Commitment Therapy Plus Illness Management n=26 Participants Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations . Acceptance and Commitment Therapy plus Illness Management
Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 3 and 6 Month Follow-up 3 Month change from baseline	-2.8 units on a scale Standard Error 2.3	-12.2 units on a scale Standard Error 1.6
Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 3 and 6 Month Follow-up 6 month change from baseline	0 units on a scale Standard Error 2.4	-12.7 units on a scale Standard Error 1.6

Adverse Events

Treatment As Usual/Waitlist

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acceptance and Commitment Therapy Plus Illness Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lilian Dindo

Baylor College of Medicine

Phone: 713-791-1414

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place