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Evaluation of Self-help Books for Depression

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ClinicalTrials.gov Identifier: NCT03796143
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Levin, Utah State University

Brief Summary:

The goal of this study is to compare the efficacy of acceptance and commitment therapy (ACT) and cognitive behavioral therapy (CBT) for depression in a bibliotherapy format and assess hypothesized mechanisms of change in depression symptomatology, quality of life, and functioning.

This study will test the following hypotheses:

  1. CBT and ACT will both result in decreased depression, distress, and self-stigma associated with depression. Life satisfaction and values progress will increase in both conditions.
  2. CBT will result in greater use of reappraisal than ACT.
  3. ACT will results in greater use of defusion and decreased psychological inflexibility than CBT.
  4. Changes in experiential avoidance and defusion will predict changes in depression in the ACT condition.
  5. Changes in reappraisal will predict changes in depression in the CBT condition.
  6. Participants who are given their choice of treatment will show better adherence and satisfaction in the intervention.

Condition or disease Intervention/treatment Phase
Mental Health Behavioral: The Mindfulness and Acceptance Workbook for Depression Behavioral: The Cognitive Behavioral Workbook for Depression Not Applicable

Detailed Description:

The investigators aim to recruit 150 participants for this RCT (50 per treatment condition). This will provided adequate power (0.80) to detect differences between groups of medium effect size (d=0.50). Note that detailed eligibility criteria are listed in the "Eligibility" section. Participants will be recruited via SONA, flyers, online postings, classroom announcements, and through the USU CBS lab website.

All study procedures will be completed online, on a computer/mobile phone. After completing informed consent online through Qualtrics, participants will complete an online baseline survey. Participants will then be randomized to one of three groups: a CBT book, an ACT book, or a choice between the two books. Participants will be asked not to access other self-help books during the study duration. A link will be provided to access the book online along with a 10-week suggested reading schedule. Participants will be asked to complete a midtreatment survey 5 weeks after the beginning of treatment, and a posttreatment survey 10 weeks after the beginning of treatment. A follow-up survey will be sent to participants 3 months after the posttreatment survey. In addition to psychological measures, these surveys will also ask about adherence and use of strategies taught in the book. Researcher contact will involve reminders to complete assessments and weekly reminders of the suggested reading schedule.

Participants assigned to the CBT condition will receive a link to access The Cognitive Behavioral Workbook for Depression (Knaus, 2008), based on a psychosocial treatment that has shown effectiveness in reducing depression symptoms (Jiménez, 2012). The primary treatment components in this book are psychoeducation (introducing the cognitive behavioral model of depression), self-assessment worksheets (e.g. identifying depressive thought patterns, separating sensations from appraisals), cognitive restructuring, using metacognition/logic, and avoiding perfectionism.

Participants assigned to the ACT condition will receive a link to access The Mindfulness and Acceptance Workbook for Depression (Strosahl & Robinson, 2008), based on a modern cognitive behavioral therapy that combines acceptance and mindfulness methods with values and behavior change methods (Hayes, Strosahl & Wilson, 2011). The primary treatment components in this book are psychoeducation (introducing the ACT model of depression), values and goals, mindfulness, acceptance, defusion, committed action, and "rewriting" inflexible life stories.

An additional subset of study participants will be given their choice of the two self-help books described above after completing the baseline assessment. Participants who are randomized to receive their choice of book will be provided a brief description of the contents of each book before making a decision.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to one of two active self-help interventions, or their choice of intervention, for the duration of the study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial (RCT) Comparing Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT) Self-help Books for Depression
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : October 7, 2019
Estimated Study Completion Date : October 7, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ACT self-help book condition
Participants in this condition will be asked to read The Mindfulness and Acceptance Workbook for Depression by Strosahl and Robinson (2008), a self-help book based on acceptance and commitment therapy.
Behavioral: The Mindfulness and Acceptance Workbook for Depression
Participants assigned to this condition will be asked to read this self-help book over an 8-week period.

Active Comparator: CBT self-help book condition
Participants in this condition will be asked to read Cognitive Behavioral Workbook for Depression by Knaus (2006), a self-help book based on acceptance and commitment therapy.
Behavioral: The Cognitive Behavioral Workbook for Depression
Participants assigned to this condition will be asked to read this self-help book over an 8-week period.

Choice of two self-help books
Participants in this condition will have the option of receiving either the self-help book by Strosahl and Robinson (2008) or the book by Knaus (2006).
Behavioral: The Mindfulness and Acceptance Workbook for Depression
Participants assigned to this condition will be asked to read this self-help book over an 8-week period.

Behavioral: The Cognitive Behavioral Workbook for Depression
Participants assigned to this condition will be asked to read this self-help book over an 8-week period.




Primary Outcome Measures :
  1. Change in Depression, Anxiety and Stress [ Time Frame: Baseline, midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline), and follow-up (3-months after posttreatment) ]
    Depression, Anxiety and Stress Scale (DASS) : a self-report measure of depression, anxiety, and stress symptoms. Higher scores indicate higher negative emotional states of depression, anxiety, and stress. This measure assesses each of these symptoms as a distinct subscale. Items are rated on a 4-point scale ranging from 0 "did not apply to me at all" to 3 "applied to me very much, or most of the time." Ranges for depression, anxiety, and stress are 0-28, 0-20, and 0-33, respectively.


Secondary Outcome Measures :
  1. Self-Stigma of Depression Scale (SSDS; Barney, Griffiths, Christensen, & Jorm, 2010) [ Time Frame: Baseline, midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline), and follow-up (3-months after posttreatment) ]
    The SSDS is a 16-item measure of self-directed stigma about one's own experience of depression and consists of subscales of shame, self-blame, social inadequacy, and help-seeking inhibition. The measure generates four subscales for shame, self-blame, help-seeking inhibition, and feelings of social inadequacy, with higher scores indicating greater presence of these experiences. The subscales are summed to calculate a total score which ranges from 16 to 80, with higher scores indicating greater overall self-stigma.

  2. Acceptance and Action Questionnaire-II (AAQ-II; Bond et al., 2011) [ Time Frame: Baseline, midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline), and follow-up (3-months after posttreatment) ]
    The AAQ-II is a 10-item measure of psychological inflexibility and experiential avoidance. Items are rated on a 7-point scale ranging from 1 "never true" to 7 "always true." A total score is calculated by reverse coding so that higher scores indicate greater psychological flexibility.

  3. Cognitive Fusion Questionnaire (CFQ; Gillanders et al., 2014) [ Time Frame: Baseline, midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline), and follow-up (3-months after posttreatment) ]
    The CFQ is a 7-item measure of cognitive fusion. Items are rated on a 7-point scale, ranging from 1 "never true" to 7 "always true." Total scores range from 7 to 49 with higher scores indicating greater levels of cognitive fusion.

  4. The Behavioral Activation for Depression Scale (BADS; Kanter, Mulick, Busch, Berlin, & Martell, 2007) [ Time Frame: Baseline, midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline), and follow-up (3-months after posttreatment) ]
    The BADS is a 25-item measure of approach and avoidance behaviors in depression, separated into two subscales. Two additional subscales measure work/school and social impairment due to depressive symptoms. Within each subscale, higher scores indicate greater frequency of these behaviors.

  5. Automatic Thoughts Questionnaire-Frequency (ATQ-30; Hollon & Kendall, 1980) [ Time Frame: Baseline, midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline), and follow-up (3-months after posttreatment) ]
    The ATQ is a 30-item measure of the frequency of automatic negative self-statements associated with depression. Items are rated on a 5-point scale, ranging from 1 "not at all" to 5 "all the time," with higher scores indicating a greater frequency of automatic thoughts.

  6. Thought Control Questionnaire-Reappraisal Subscale (TCQ; Wells & Davies, 1994) [ Time Frame: Baseline, midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline), and follow-up (3-months after posttreatment) ]
    The TCQ-Reappraisal subscale is 6-item measure of cognitive reappraisal of negative thoughts. Items are rated on a 4 point scale ranging from 1 "never" to 4 "almost always" indicating the frequency of cognitive reappraisal of negative thoughts. Total scores range from 6 to 24, with higher scores indicating greater frequency of cognitive reappraisal of negative thoughts.


Other Outcome Measures:
  1. Adherence to self-help book [ Time Frame: Midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline) ]
    Participants will be asked to rate their adherence to the exercises in the book with a single question on 7-point scale from "Did all recommended assignments" to "Did no recommended assignments," with higher scores indicating a greater proportion of the assignments were completed. This is adapted from previous studies of self-help adherence (Abramowitz, Moore, Braddock, & Harrington, 2009).

  2. Satisfaction with self-help book [ Time Frame: Posttreatment (10 weeks after baseline) ]
    Participants will be asked to rate 7 items evaluating their satisfaction with the self-help book on a 6-point scale from "Strongly disagree" to "Strongly agree." The scale produces a total score ranging from 7 to 42, with higher scores indicating greater satisfaction with the book. These items have been used to evaluate program satisfaction in previous self-help research conducted by our lab (e.g., Levin, Pierce, & Schoendorff, in press).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Enrolled at Utah State University
  • Have not participated in other self-help studies run by the USU CBS Lab
  • Interested in using self-help book for depression
  • Elevated depressive symptoms as determined by scoring a 10 or higher on the depression subscale of the Depression, Anxiety, and Stress Scale (DASS-21)

Exclusion Criteria:

  • Below the age of 18
  • Not a student at Utah State University
  • Have participated in other self-help studies run by the USU CBS Lab
  • Not interested in using self-help book for depression
  • No elevated depressive symptoms as determined by scoring lower than 10 on the depression subscale of the Depression, Anxiety, and Stress Scale (DASS-21)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796143


Contacts
Contact: Carter H Davis, BFA (385) 374-0338 carter.davis@aggiemail.usu.edu

Locations
United States, Utah
Utah State University Recruiting
Logan, Utah, United States, 84322
Contact: Michael Levin, PhD    541-531-3892    mike.levin@usu.edu   
Principal Investigator: Michael Levin, PhD         
Sub-Investigator: Michael Twohig, PhD         
Sponsors and Collaborators
Utah State University
Investigators
Principal Investigator: Michael Levin, PhD Utah State University

Publications:
Hayes, S. C., Strosahl, K. D., & Wilson, K. G. (2011). Acceptance and commitment therapy: The process and practice of mindful change. Guilford Press.
Hollon, S. D., & Kendall, P. C. (1980). Cognitive self-statements in depression: Development of an automatic thoughts questionnaire. Cognitive Therapy and Research, 4(4), 383-395.
Jiménez, F. J. R. (2012). Acceptance and commitment therapy versus traditional cognitive behavioral therapy: A systematic review and meta-analysis of current empirical evidence. International Journal of Psychology and Psychological Therapy, 12(3), 333-358.
Knaus, W. J. (2006). The cognitive behavioral workbook for depression: a step-by-step program. New Harbinger Publications.
Levin, M. E., Haeger, J., & Cruz, R. A. (2018). Tailoring Acceptance and Commitment Therapy Skill Coaching in the Moment Through Smartphones: Results from a Randomized Controlled Trial. Mindfulness, 1-11.
Masuda, A., & Tully, E. C. (2012). The role of mindfulness and psychological flexibility in somatization, depression, anxiety, and general psychological distress in a nonclinical college sample. Journal of Evidence-Based Complementary & Alternative Medicine, 17(1), 66-71.
Strosahl, K. D., & Robinson, P. J. (2008). The mindfulness and acceptance workbook for depression: Using acceptance and commitment therapy to move through depression and create a life worth living. New Harbinger Publications.

Responsible Party: Michael Levin, Associate Professor, Utah State University
ClinicalTrials.gov Identifier: NCT03796143     History of Changes
Other Study ID Numbers: 9766
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Behavioral Symptoms