Depression, Anxiety
Conditions
Brief summary
100 participants will be enrolled in a two-armed randomized controlled trial of the Accumulated Depression and Anxiety Plans and Treatments (ADAPT) platform which integrates internet Cognitive Behavioral Therapy (iCBT) to determine impact on symptoms of depression and anxiety. This trial will pilot the effectiveness of the ADAPT platform, and evaluate the extent to which the ADAPT platform engages putative targets of personal relevance, skills use, and skills mastery.
Detailed description
The investigators will enroll 100 participants in a two-armed randomized controlled trial of the ADAPT platform (iCBT). Participants will be randomly assigned to receive either the ADAPT platform (treatment) or a similar self-guided platform (control) that contains the didactic material (learning) but lacks the ADAPT platforms crowd features. Participants will use their assigned platform for a treatment period of 8 weeks. Participants will receive trial assessments at baseline, week 4, and week 8 (post-treatment). Follow-up evaluations will occur at 16 weeks to evaluate maintenance of gains. This pilot effectiveness trial aims to determine the impact on symptoms of depression and anxiety and whether the platform engages the putative targets of personal relevance, relationship, resulting in increased skills mastery and skills use.
Interventions
BEHAVIORALADAPT Platform (Treatment)
The ADAPT platform consists of 2 modules based on evidence-based strategies from cognitive-behavioral therapy including cognitive restructuring and behavioral experiments. The platform includes didactic material, interactive tools, and crowd-features. Crowd-features are present to increase personal relevance of content and to promote engagement with the ADAPT platform through accountability. Crowd-features include requesting, responding, and exemplars.
BEHAVIORALADAPT Comparison (Control)
The control platform is a self-guided version of the ADAPT platform that includes no crowd-features. As such it will include only didactic material on cognitive restructuring and behavioral experiments and interactive tools.
Sponsors
National Institute of Mental Health (NIMH)
Mental Health America
Northwestern University
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will be unaware of which condition they have been assigned.
Intervention model description
Participants will be randomly assigned to receive either the treatment condition (ADAPT platform, iCBT platform comprised of didactic and interactive content), or a control condition (iCBT comparison platform comprised only of didactic content).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\) Completion of the Mental Health America Screening to Supports (MHA S2S) or significant mood and anxiety symptoms as defined by an accepted cut-off on a validated measure the Depression Anxiety and Stress Scale (DASS). The accepted cut-off is scores greater than 22; * 2\) able to speak and read English; * 3\) at least 18 years of age.
Exclusion criteria
* 1\) severe suicidality (has ideation, plan, and intent)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Scores at Week 16 | Absolute scores at Week 16 | The primary outcome of symptoms of depression will be measured with the self-report depression subscale of the Depression Anxiety Stress Scale (DASS). The subscale for depression ranges from 7 to 28 with lower values (lowest value = 7) indicating lower levels of depression and higher values (highest value = 28) indicating higher levels of depression. |
| Anxiety Scores at 16 Weeks | Absolute scores at Week 16 | The primary outcome of symptoms of anxiety will be measured with the self-report anxiety subscale of the Depression Anxiety Stress Scale (DASS). The subscale for anxiety ranges from 7 to 28 with lower values (lowest value = 7) indicating lower levels of anxiety and higher values (highest value = 28) indicating higher levels of anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive and Behavioral Skills Scores at 16 Weeks | Absolute scores at Week 16 | A secondary outcome is the Frequency of Actions and Thoughts (FATS), which assesses the use of cognitive and behavioral skills. Total scores indicate the average of each item rating and range from 0-4. Lower scores indicate less frequent use of cognitive and behavioral skills and higher scores indicate more frequent use of cognitive and behavioral skills. |
| Self-efficacy Scores at 16 Weeks | Absolute scores at Week 16 | A secondary outcome is the Coping Self-Efficacy (CSE), which produces a single score that ranges from 0-260 with lower scores representing lower coping self-efficacy and higher scores indicating higher coping self-efficacy. |
| Accountability Scores at 16 Weeks | Absolute scores at Week 16 | A secondary outcome is the Supportive Accountability Questionnaire (SAQ), which produces a single score than ranges from 7-91. Data reported are the SAQ total scores with lower levels indicating less supportive accountability and higher values indicating greater supportive accountability. |
| Social Functioning Scores at 16 Weeks | Absolute scores at Week 16 | Functioning will be assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Scale which produces T-scores that have a mean of 50 and a standard deviation of 10. Lower scores indicate lower participation in social roles and activities and higher scores indicate higher participation in social roles and activities. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the Mental Health America screening website between Feburary 2021 and September 2021. The first participant was enrolled on February 18, 2021 and the last participant was enrolled on September September 3, 2021.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Participants randomly assigned to this condition will receive the ADAPT platform (treatment) for a treatment period of 8 weeks.
ADAPT Platform (Treatment): The ADAPT platform consists of 2 modules based on evidence-based strategies from cognitive-behavioral therapy including cognitive restructuring and behavioral experiments. The platform includes didactic material, interactive tools, and crowd-features. Crowd-features are present to increase personal relevance of content and to promote engagement with the ADAPT platform through accountability. Crowd-features include requesting, responding, and exemplars. | 56 |
| Control Participants randomly assigned to this condition will receive a similar self-guided platform (control) for a treatment period of 8 weeks.
ADAPT Comparison (Control): The control platform is a self-guided version of the ADAPT platform that includes no crowd-features. As such it will include only didactic material on cognitive restructuring and behavioral experiments and interactive tools. | 51 |
| Total | 107 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 16 | 13 |
| Overall Study | Withdrawal by Subject | 5 | 3 |
Baseline characteristics
| Characteristic | Total | Treatment | Control |
|---|---|---|---|
| Age, Continuous | 33.92 years STANDARD_DEVIATION 12.34 | 33.41 years STANDARD_DEVIATION 11.41 | 34.57 years STANDARD_DEVIATION 13.39 |
| Depression Anxiety Stress Scale (DASS) | 64.51 scores on a scale STANDARD_DEVIATION 24.06 | 65.7 scores on a scale STANDARD_DEVIATION 23.8 | 63.2 scores on a scale STANDARD_DEVIATION 24.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 8 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 85 Participants | 48 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 11 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) White | 68 Participants | 36 Participants | 32 Participants |
| Sex/Gender, Customized Female | 64 Participants | 33 Participants | 31 Participants |
| Sex/Gender, Customized Male | 41 Participants | 22 Participants | 19 Participants |
| Sex/Gender, Customized Non-Binary | 2 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 51 |
| other Total, other adverse events | 0 / 56 | 0 / 51 |
| serious Total, serious adverse events | 0 / 56 | 0 / 51 |
Outcome results
Primary
Anxiety Scores at 16 Weeks
The primary outcome of symptoms of anxiety will be measured with the self-report anxiety subscale of the Depression Anxiety Stress Scale (DASS). The subscale for anxiety ranges from 7 to 28 with lower values (lowest value = 7) indicating lower levels of anxiety and higher values (highest value = 28) indicating higher levels of anxiety.
Time frame: Absolute scores at Week 16
Population: Data was analyzed using an intent-to-treat analysis including all participants who provided baseline data entered into a mixed models analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Anxiety Scores at 16 Weeks | 12.4 score on a scale | Standard Deviation 10.8 |
| Control | Anxiety Scores at 16 Weeks | 11.0 score on a scale | Standard Deviation 9.77 |
p-value: 0.6195% CI: [-2.52, 4.32]Mixed Models Analysis
Primary
Depression Scores at Week 16
The primary outcome of symptoms of depression will be measured with the self-report depression subscale of the Depression Anxiety Stress Scale (DASS). The subscale for depression ranges from 7 to 28 with lower values (lowest value = 7) indicating lower levels of depression and higher values (highest value = 28) indicating higher levels of depression.
Time frame: Absolute scores at Week 16
Population: Data was analyzed using an intent-to-treat analysis including all participants who provided baseline data entered into a mixed models analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Depression Scores at Week 16 | 15.7 score on a scale | Standard Deviation 12.9 |
| Control | Depression Scores at Week 16 | 15.7 score on a scale | Standard Deviation 10.3 |
p-value: 0.7995% CI: [-3.71, 4.88]Mixed Models Analysis
Secondary
Accountability Scores at 16 Weeks
A secondary outcome is the Supportive Accountability Questionnaire (SAQ), which produces a single score than ranges from 7-91. Data reported are the SAQ total scores with lower levels indicating less supportive accountability and higher values indicating greater supportive accountability.
Time frame: Absolute scores at Week 16
Population: Data was analyzed using an intent-to-treat analysis including all participants who provided baseline data entered into a mixed models analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Accountability Scores at 16 Weeks | 75.1 score on a scale | Standard Deviation 23.3 |
| Control | Accountability Scores at 16 Weeks | 74.7 score on a scale | Standard Deviation 22 |
p-value: 0.10995% CI: [-15.28, 1.54]Mixed Models Analysis
Secondary
Cognitive and Behavioral Skills Scores at 16 Weeks
A secondary outcome is the Frequency of Actions and Thoughts (FATS), which assesses the use of cognitive and behavioral skills. Total scores indicate the average of each item rating and range from 0-4. Lower scores indicate less frequent use of cognitive and behavioral skills and higher scores indicate more frequent use of cognitive and behavioral skills.
Time frame: Absolute scores at Week 16
Population: Data was analyzed using an intent-to-treat analysis including all participants who provided baseline data entered into a mixed models analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Cognitive and Behavioral Skills Scores at 16 Weeks | 2.03 score on a scale | Standard Deviation 0.84 |
| Control | Cognitive and Behavioral Skills Scores at 16 Weeks | 1.78 score on a scale | Standard Deviation 0.9 |
p-value: 0.08895% CI: [-0.05, 0.68]Mixed Models Analysis
Secondary
Self-efficacy Scores at 16 Weeks
A secondary outcome is the Coping Self-Efficacy (CSE), which produces a single score that ranges from 0-260 with lower scores representing lower coping self-efficacy and higher scores indicating higher coping self-efficacy.
Time frame: Absolute scores at Week 16
Population: Data was analyzed using an intent-to-treat analysis including all participants who provided baseline data entered into a mixed models analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Self-efficacy Scores at 16 Weeks | 134.0 score on a scale | Standard Deviation 58.6 |
| Control | Self-efficacy Scores at 16 Weeks | 124.0 score on a scale | Standard Deviation 57.8 |
p-value: 0.14295% CI: [-4.62, 31.99]Mixed Models Analysis
Secondary
Social Functioning Scores at 16 Weeks
Functioning will be assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Scale which produces T-scores that have a mean of 50 and a standard deviation of 10. Lower scores indicate lower participation in social roles and activities and higher scores indicate higher participation in social roles and activities.
Time frame: Absolute scores at Week 16
Population: Data was analyzed using an intent-to-treat analysis including all participants who provided baseline data entered into a mixed models analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Social Functioning Scores at 16 Weeks | 78.4 T-score | Standard Deviation 14.2 |
| Control | Social Functioning Scores at 16 Weeks | 79.3 T-score | Standard Deviation 16 |
p-value: 0.73695% CI: [-6.92, 4.89]Mixed Models Analysis